Tag Archives: neuropathy

Trigger events for Charcot neuroarthropathy: A retrospective review

by Brent H. Bernstein DPM  FACFAS1, Payel Ghosh DPM2, Colleen Law DPM3, Danielle Seiler DPM4, Thuyhien Vu DPM5

The Foot and Ankle Online Journal 10 (2): 3

Charcot arthropathy is a rare, but devastating disease process that has significantly debilitating sequelae. While several theories have been discussed within the literature regarding the causative factors, there remains much debate to the exact pathogenesis. Nevertheless, recognition and timely treatment of this issue remains a paramount task for every healthcare provider. In order to accomplish this, we investigated specific trigger events that led to the onset of the Charcot, by subjectively interviewing patients.  Ultimately, we were able to identify acute trauma, surgical events, infections, and also overuse injuries all as inciting events to this disease process. The overall goal of this paper is to improve recognition of the possible triggers that leads to the Charcot disease process in order to better care for patients. 

Keywords: Charcot, diabetic foot, trigger event, neuropathy, neuroarthropathy

ISSN 1941-6806
doi: 10.3827/faoj.2017.1002.0003

1 – Attending, Research Coordinator, Podiatry Residency, St. Luke’s Hospital Allentown, PA
2 – Podiatric Resident, St. Luke’s Hospital Allentown, PA
3 – Podiatric Resident, St. Luke’s Hospital Allentown, PA
4 – Associate at Premier Foot & Ankle Associates Wyomissing, PA
5 – Teaching Staff, Mercy Medical Center, Cambodia
* – Corresponding author: ghosh.payel@gmail.com


Charcot neuroarthropathy is a progressive and destructive process that can lead to debilitating sequelae such as ulcerations, foot deformity, fracture, dislocations, and even amputation [1]. Charcot has been associated with a number of different conditions; however, today diabetes mellitus is found to be the primary cause [2]. The epidemiological data shows that the prevalence of Charcot arthropathy in diabetic patients ranges from 0.08% to 13% while the incidence varies between 0.10% and 29% [1]. This wide difference in incidence within the literature is linked to higher index of suspicion from tertiary providers, such as wound care specialists.

The exact pathogenesis of Charcot remains ill defined.  The neurotraumatic and neurovascular theories continue to be the fundamental teachings; however, it is likely that there are a combination of several mechanisms involved [3]. It is thought that autonomic neuropathy, creates a hyperemic response by means of arterio-venous shunting leading to bone resorption and osteopenia.  Furthermore, it is suggested that motor neuropathy causes muscle imbalances within the foot, which leads to repetitive microtrauma.  This alone, or in combination with a traumatic event begins the process of osseous destruction.  Sensory neuropathy prevents the patient from recognizing this microtrauma, thus propagating the Charcot process [4].   Newer relate the pathogenesis to the disruption in the Charcot patient’s ability to regulate inflammation.  This results in increased levels of proinflammatory cytokines, such as tumor necrosis factor alpha (TNFα) and interleukin-1β (IL-1β) and a decrease of anti-inflammatory factors interleukin-4 and interleukin-10.  Increased TNFα leads to a cytokine cascade that eventually results in the activation of NF-κB, which causes osteoclast precursor cells to become mature osteoclasts.  This process causes excessive bone turnover due to increased osteoclast activity, thus resulting in the Charcot process [5].

To our knowledge, there have been no published reports aimed specifically at the initial inciting event that triggers the acute Charcot cascade. The purpose of this study was to analyze the trigger events leading to the development of Charcot neuroarthropathy with the hope that this information will give rise to preventative measures for these at risk patients.   

Methods

Data were obtained from the medical records of patients being treated by the primary author (BHB) with a diagnosis of Charcot neuroarthropathy between 2003 and 2010.  The diagnosis of Charcot was based on clinical presentation and radiographic evidence, including advanced imaging studies.  Swelling, erythema, warmth, pain, and a temperature gradient of four degrees Fahrenheit or more between the affected and contralateral limb were pertinent to the clinical diagnosis.  The clinical diagnosis was then confirmed with MRI or triple phase bone scan.

A total of 211 feet from the records were identified with Charcot; however, only 179 had complete data available. The triggering event was identified through patient interview and clinical examination.  Questions regarding prior trauma, surgery, infection, or overuse were discussed in detail in order to help determine the inciting event.  In 70 of the feet, a trigger could not be identified, and thus were excluded from the data analysis.  The triggering event preceding the acute onset of Charcot was analyzed and classified into five major categories.  The first category was acute injury, which included any single, identifiable event such as fractures or sprains that resulted in the onset of the Charcot process.  Diabetic ankle fractures were placed in their own separate category from the acute injury category due to their higher morbidity rate and more unique surgical protocol vs. a non-ankle fracture.  The surgical category consisted of patients who developed Charcot following recent non-elective or elective foot surgery.   The patients who had a recent of history of infection as an inciting event, but did not undergo any surgical procedures was placed into the infection category.  Lastly, the overuse category was for individuals who had an identifiable continued repetitive trauma from a particular event over a period of time.  Each foot was then classified based on Sander’s anatomic classification system as follows: Type 1=forefoot, Type II = tarso-metatarsal joint, Type III = naviculocuneiform and midtarsal joints, Type IV = ankle joint, Type V = calcaneus [1].  

The frequency of each trigger category as well as each anatomic location was analyzed.  For exploratory purposes only, given the small subgroup sizes, a chi square test of general association was conducted to compare trigger types by anatomic site.  A p-value < .05 denotes statistical significance.

Results

Complete data was available on 179 out of 211 feet.  A specific trigger event could not be identified in 70 feet and these were excluded from the data analysis; therefore, the final cohort included 109 feet.  Demographic information is summarized in Table 1.  The mean age was 55.97 years old ranging from 28 to 84.  There were 64 males and 45 females included in the study.  90% of our patient population was diabetic while the other 10% had neuropathy from other etiologies. Other etiologies did include, but were not limited to Alcoholic Neuropathy, Cauda Equina Syndrome, Agent Orange Syndrome, Idiopathic and Hypothyroidism. Of note, there were two cases of combined Diabetic and Syphilitic Neuropathy.

 

Age

(mean + standard deviation)

Gender Diagnosis
55.97 + 11.72(range 28 – 84) 64 male (58.7%)45 female (41.3%) Type II IDDM: 48 (44%)Type II NIDDM: 26 (23.9%)

Type I DM: 13 (11.09%)

DM Type unspecified: 11 (10%)

Idiopathic neuropathy: 2 (1.8%)

Syphilis/Type I DM: 2 (1.8%)

Alcohol/ETOH: 2 (1.8%)

Agent Orange poisoning: 1 (.9%)

Cauda Equina Syndrome: 1 (.9%)

Hypothyroid: 1 (.9%)

Type II IDDM/Agent Orange: 1 (.9%)

Non-diabetic: 1 (.9%)

Table 1 Demographic Characteristics (N=109)

Overall, the two most common trigger types identified were acute injury and overuse at 44% (48/109) and 18.3% (20/109) respectively as seen in Table 2.  These were followed by diabetic ankle fracture and foot surgery (17/109) for the third most common trigger at 15.6% (17/109).  Infection was the trigger event in 6.4% of the total feet (7/109).

 

Trigger Type Frequency (%)
Acute injury 48 (44%)
Overuse 20 (18.3%)
DM Ankle Fx 17 (15.6%)
Sx 17 (15.6%)
Infection 7 (6.4%)
TOTAL 109

Table 2 Trigger Category Percentages

After categorizing the inciting event into a classification of a trigger type, the data was analyzed to compare each event to its associated anatomic location. Acute Trauma was distributed affecting the forefoot 4.2% (2/48), the tarsometatarsal joint 45.8% (22/48), the midtarsal 22.9% (11/48), the ankle 18.8% (9/48) and the Calcaneus 8.3%  (4/48). Diabetic ankle fractures accounted for 17 cases and led to a midtarsal arthropathy 5.9% (1/17) and an ankle arthropathy 94.1% (16/17) of the time. Surgical intervention resulted in 17.6% (3/17) forefoot arthropathy, 41.2% (7/17) tarsometatarsal arthropathy, 23.5% (4/17) midtarsal arthropathy and 7.6% (3/17) ankle arthropathy.  Infection, which accounted for 7 cases of arthropathy, was observed 71.4% (5/7) at the tarsometatarsal level and 28.6% (2/7) at the level of the ankle joint. Overuse injury was observed to lead to arthropathy in 20 patients with 50% of those observed at the tarsometatarsal level (10/20), 45% (9/20) at the midtarsal level and 5% (1/20) at the level of the ankle joint.

Based on a chi square test of general association, there is a statistically significant association between trigger category and anatomic classification (p < .0001) in terms of the difference in frequencies (Table 3).

 

Anatomic Classification
I II III IV V
Trigger Category Acute Trauma Count 2 22 11 9 4
% within Trigger Category 4.2% 45.8% 22.9% 18.8% 8.3%
DM Ankle Fx Count 0 0 1 16 0
% within Trigger Category .0% .0% 5.9% 94.1% .0%
Sx Count 3 7 4 3 0
% within Trigger Category 17.6% 41.2% 23.5% 17.6% .0%
Infection Count 0 5 0 2 0
% within Trigger Category .0% 71.4% .0% 28.6% .0%
Overuse Count 0 10 9 1 0
% within Trigger Category .0% 50.0% 45.0% 5.0% .0%
Total Count 5 44 25 31 4
% within Trigger Category 4.6% 40.4% 22.9% 28.4% 3.7%

Table 3 Association Between Anatomic Site and Trigger Categories

Discussion

This study examines patients with Charcot neuroarthropathy and investigates the individual trigger events leading to the development of the disease process to further our insight as healthcare providers. The different trigger categories, as well as the anatomic classifications for each event were evaluated.  Our results indicate that the two most common triggers for developing acute Charcot were acute trauma and overuse.  Also, 40% of the total cases involved, developed Sanders type II Charcot.  Anatomic site II arthropathy was the most common form of Charcot that developed in all of the trigger categories, with the exception of a diabetic ankle fracture, which was the second most common and generated mainly type IV arthropathy.  This supports the general teaching that tarso-metatarsal joint Charcot arthropathy is traditionally the most common anatomic type that is observed [6]. In the process of investigating individual trigger events, the authors encountered patterns of inciting events, while no statistical significance could be drawn from these anecdotal incidences. One mechanism that was most closely associated with a Sanders type II arthropathy was the action of stepping on a ladder. This becomes important as a significant number of our patients work in a more industrial environment and are likely prone to an overuse or acute type injury of the tarsometatarsal complex. A similar mechanism that was demonstrated in a handful of patients was the actions of stepping down to a lower level or onto a curb.  Through these mechanisms was both Sanders II and Sanders IV type injuries were associated. Ultimately, while the collection of these events was not statistically significant, they have provided enlightenment to the providers and have affected the questions asked during intake today.

The results of this study were compared to current literature available where other researchers have attempted to understand the causes of Charcot neuroarthropathy. When looking further into the data it is interesting to note that 39% of the original 179 feet could not recall any precipitating event to their acute Charcot.  These patients were ultimately eliminated from data analysis for the purpose of this study.  This is in contrast to Armstrong et al where 73% of the subjects could not identify a single trigger event; however, it is possible that there is overlap between the overuse category and these patients.7 Furthermore, Papanas et al reported patients recalling a traumatic event in 36% of their patient population with a 12% association with surgical intervention [6]. Regardless, it is important to remember a singular trigger event may not always be identifiable and Charcot arthropathy should not be ruled out of the differential diagnosis subsequently.

In order to perform a comprehensive assessment of the diabetic foot, it is important to incorporate other considerations. Foltz et al evaluated both vascular and neurological findings in patients with Charcot foot deformity in order to identify high risk factors for development of a protocol for early detection in the non-hospital setting [8].   Additionally, Armstrong and Lavery analyzed peak plantar pressures of Charcot and non-Charcot feet to examine if this was a risk factor for or associated with the development of Charcot [7].  In conclusion, the authors felt that measuring these plantar pressures may be an effective addition to the screening protocol for these types of patients [9]. Rajbhandari et al proposed that pathognomonic factors for Charcot neuroarthropathy, likely involve a synthesis of competing classic theories [10]. It was believed that a substantial number of cases were likely triggered by a traumatic event, which also instigated an abnormal vascular reflex resulting in hyperemia to osseous components [11].

The limitations of this study includes the fact that it was a retrospective analysis.  Additionally, the report of each trigger event was subjective and dependent upon the insight from each patient.

We believe that the information from this study could be used in order to better educate our diabetic neuropathic patients on the topic of Charcot neuroarthropathy to aid in preventing its onset or to expedite treatment modalities with earlier recognition. Another important point for both clinicians to remember and for patient teaching purposes, is that the repetitive and overuse activities should not be overlooked as these can lead to a significant amount of neuroarthropathy. It is extremely important that all diabetic patients with peripheral neuropathy are properly educated on Charcot. The repercussions of a missed diagnosis given the expansive list of complications secondary to Charcot neuroarthropathy must be impressed upon high-risk patients. The intention of this paper was to display the different trigger categories and their frequencies so that this information could be used for prevention and educational purposes.

Funding Declaration The authors have no financial interests to disclose. Neither this research, nor its publication was funded.

Conflict of Interest Declaration The authors have no interests to declare.

References

  1. Frykberg RG, Belczyk R.  Epidemiology of the Charcot Foot.  Clinics in Podiatric Medicine and Surgery. 2008;25:17-28.
  2. Wukich DK, Sung W. Charcot Arthropathy of the Foot and Ankle: Modern Concepts and Management. Review. Journal of Diabetes and its Complications 2008: 1-18. (PubMed).
  3. Pinzur MS. Current Concepts Review: Charcot Arthropathy of the Foot and Ankle.  Foot Ankle International 2007;28:952-959. (PubMed).
  4. Van der Ven A, Chapman CB, Bowker JH.  Charcot Neuroarthropathy of the Foot and Ankle. Journal of the American Academy of Orthopedic Surgeons 2009;17: 562-571. (PubMed).
  5. Kaynak G, Birsel O, Guven MF, Ogut T. An Overview of the Charcot Foot Pathophysiology. Diabetic Foot and Ankle 2013; 4: 21117. (PubMed).
  6. Gouveri E, Papanas N. Charcot Osteoarthropathy in Diabetes: A Brief Review with an Emphasis on Clinical Practice. World Journal of Diabetes; 2011 May 15; 2 (5); 59-65.  (PubMed).
  7. Armstrong DG, Todd WF, Lavery LA, Harkless LB, Bushman TR. The Natural History of Acute Charcot’s Arthropathy in a Diabetic Foot Specialty Clinic. Diabet Med 1997;14:357-363.  (PubMed).
  8. Foltz KD, Fallat LM, Schwartz S. Usefulness of a Brief Assessment Battery for Early Detection of Charcot Foot Deformity in Patients with Diabetes. JFAS 2004;43:87-92. (PubMed).
  9. Armstrong DG, Lavery L. Elevated Peak Plantar Pressures in Patients who have Charcot Arthropathy. JBJS 1998;80A:365-369. (PubMed).
  10. Rajbandhari SM,  Jenkins RC, Davies C, Tesfaye S. Charcot Neuroarthropathy in Diabetes Mellitus. Diabetologia 2002; 45: 1085-1096. (PubMed).
  11. Petrova NL, Edmonds ME. Acute Charcot Neuro-Osteoarthropathy. Diabetes/ Metabolism Research and Reviews 2016; 32 (Suppl. 1): 281-286. (PubMed).

Distant Intentionality Healing (DIH): A randomized double blind study on post operative care and cost to care for complications following foot and ankle surgery

by Gerald T. Kuwada, MPH, NMD

The Foot and Ankle Online Journal 5 (1): 1

A randomized double blind study was completed to determine the efficacy of Distant Intentionality Healing (DIH) on post operative complications following foot and ankle surgery. The results indicate that there is significant difference between the control group and the group receiving DIH p< .05 level of significance. The cost to care for complications was also significant with the DIH complication being $393/adverse event and the control group being $985/adverse event. The national average is $1388/adverse event.

Key Words: Monofilament, tuning fork, ankle reflex, superficial pain, neuropathy.

Accepted: December, 2011
Published: January, 2012

ISSN 1941-6806
doi: 10.3827/faoj.2012.0501.0001


In 2007 US health care cost 2 trillion dollars, the most expensive health care system in the world. Yet, according to the WHO (World Health Organization) the US health care system is ranked 37th in the world based on quality of care, fairness of the health care system and accessibility for the poor. [1] Part of the cost of health care in the US is from the 45 million operations performed in 2007. Of these cases, 25 million operations were performed under general anesthesia. There were 18 million adverse events after the operations or a rate of 40%. The cost to care for these adverse events was 25 billion dollars or 1,388 dollars per adverse event. [2]

The most frequent complication was SSI (surgical site infection) at 40%. Venous thromboemboli was second most frequent complication followed by postoperative cardiac event and fourth respiratory failure. In orthopedic cases, death occurred in about 0.92% of the operations in the US. [3] The range of cost to care for adverse events was 600-50,000 dollars. Complications are not only catastrophic to the patient and family, in the US 50% of the bankruptcies filed were due to medical expenses for health care and included patients with medical insurance. [2] This is not the case for patients in Canada, England, and France who have a form of universal health care.

Thus, if surgeons could reduce or eliminate the high complication rate substantially, this would be of great benefit to the patient and reduce the overall health care cost. Such a benefit might be possible with what is called Distant Intentionality Healing(DIH) or SHT (Samadhi Healing Technique) used by the healer.

What is Distant Intentionality Healing (DIH)? DIH is the mental intention to benefit another human being, living organism and human events. These mental intentioned techniques include prayer, Reiki, Therapeutic Touch, Samadhi Healing Technique (author uses this technique), Chi Kung and other human energy based techniques. Previous prospective randomized double blind studies have demonstrated the efficacy of DIH on postoperative pain reduction following foot and ankle surgery. [6] DIH patients had significantly less pain postoperatively, more patients had complete pain relief postoperatively and greater pain reduction compared to the control group. Furthermore, other studies have shown significant benefit to patients who received DIH with autoimmune disease (AIDS) and coronary artery disease (CAD) as a result of acute myocardial infarct (MI). [7,8]

Patients receiving DIH had fewer complications, less doctor visits and took less medications contrasted to the control group with AIDS. [7] Similarly, patients admitted to the hospital for acute MIs had no recurrence of MI, had less cardiac damage to the ventricle, had less complications, and recovered faster than the control group patients.8 Other healing modalities such as Reiki, Chi Kung and Therapeutic Touch have also demonstrated pain reduction post operatively for surgical patients. [9-12]

The first question to be answered by this study is can DIH reduce the incidence of postoperative complications following foot and ankle surgery compared to the control group? The second question is, can DIH decrease the cost to care for complications following foot and ankle surgery compared to the control group and the national average?

Methods

The study follows the guidelines from the Helsinki declaration of 1975 and modified version of 2000. Each patient reviewed and signed consent forms agreeing to participate in this research study. They were informed of any potential harm or side effects and the nature of the study (surgical complications).

There were a total of 195 patients in this prospective study which took 4 years to complete. Eighty-seven patients had 98 surgical procedures were randomly selected for DIH –SHT group. The control group comprised of 107 patients having 125 surgical procedures performed on them. The DIH-SHT group received the healing energy twice per day for 2 minutes each session for up to 4 weeks after their surgery. The surgeon is the healer in this study and performed surgery on all 195 patients. Both groups were not informed of what group they were assigned.

The healer was not informed by the research assistant which patients were assigned to the control group or the DIH-SHT group. Table 1 lists the procedures performed on the patients. Table 2 lists the complications that were recorded for each patient in their group and what procedures were performed on them. Table 3 lists the cost of care for the control group complications and the DIH-SHT group complications. The patients in both groups were followed for a minimum of 6 months after their surgery.

Table 1  List of operative procedures performed. SHT: Samadhi Healing Technique.

Table 2   Number of complications per procedure.  AD:  Adhesion, CP:  Chronic pain, CRPS:  Chronic regional pain syndrome, R:  Recurrence, SI:  Superficial infection.

Table 3   Cost to treat postoperative complications.

The healer performed DIH (specifically called Samadhi Healing Technique or SHT) twice per day at 5 a.m. and midnight daily for the 4 week period for patients immediately after their surgeries. The healer visualized patients and with intention, projected the thought of no complications to group DIH-SHT patients even though the healer did not know who they were. The DIH-SHT group patients were not told if and when they were receiving such intentional healing during the 4 week period post operative. At the end of 6 months postoperative, complications were documented from their medical records. If there were complications, the cost of care was also documented from their medical financial records and used for calculations in Table 3 for both groups.

Results

The results indicate significantly less postoperative complication rate with p

The 2 in the DIH-SHT group were nail spicules after partial matrixectomy. For Table 1, of the 9 operatory categories, each operative procedure had complications for the control group. The DIH-SHT group had 4 surgical category procedures where complications were reported. There were 5 surgical categories where patients did not have complications in the DIH-SHT group. In Table 3, of the 20 complications the control group had 5/20 and the DIH group had 4/20 categories. As for the cost of caring for complications from both groups, the DIH-SHT group averaged $393 per adverse event. The control group had an average of $985 / per adverse event. The national average was $1,388 / per adverse event. The total cost of treating DIH-SHT complications was $3,536 and for the control group the cost was $23,634.

Discussion

There is a significant reduction in complication rate for the DIH-SHT group patients at p

Previous studies have also corroborated significant postoperative pain reduction after foot and ankle surgery. There were no reported side effects of DIH-SHT treatment, no complications, and no extra medical costs incurred by the patient. The healer (author and surgeon) uses a DIH technique as previously described as SHT or Samadhi Healing Technique. The technique incorporates meditation, Samadhi or state of higher consciousness, focus, visualization and intentionality. The DIH energy is imagined to encircle all group B or DIH group patients even though the healer does not know who these patients are. The patients are unaware of when they receive the DIH healing intention.

The specific intention of no complications is transferred to the patient’s consciousness even though they are unaware that they have received the DIH energy. Not all patients were free of complications in the DIH group. This is attributed to either non-compliance by the patient regarding postoperative instructions or the patient was not susceptible to the DIH healing. Using the same DIH-SHT technique in other studies by the author there was significant reduction in postoperative pain, less pain medication used, and distance didn’t appear to affect the DIH-SHT effect. [6,7]

Currently there is no accepted physics paradigm that explains how DIH and SHT works. Recently, physicists postulated that DIH may be explained by the theory of entanglement and non-locality found in quantum mechanics. [13] According to these theories, protons of complex and separate systems entangle and interact with each other. [14]

Thus electrons vibrating in synchrony can be separated by several inches to billion light years away and point A and point B will receive the same message at about the same time despite the distance between the protons or electrons. The entanglement allows the message to be sent faster than the speed of light.

A recent study revealed neurons from separate preparations connected to each other. [14] The non-locality theory reveals that there is no central location in the brain where our consciousness can be located and identified. Yet, the healer and recipient can connect as documented by EEG studies when the recipient’s brain wave synchronizes with the healer’s brain wave during a healing session. [15]

During mystical, meditative and spiritual states, using SPECT or single photon emission computed tomography scans showed reduced brain metabolic activity in the posterior parietal lobe during intense or peak religious moments in Tibetan meditators and Franciscan nuns. [16]

In another study, meditation was shown to decrease anxiety and enhance positive emotional feelings and increase the immune response. [17] In five people who practiced Kundalini yoga, changes were noted in the area of the autonomic nervous system. This included the dorsolateral, prefrontal and parietal cortices, hippocampus, temporal lobe and the anterior cingulated cortex. [18]

Meditation is a vital part of SHT used by the author. It is preparatory prior to connecting to the patient and allows the healer to move into Samadhi or higher consciousness. During Samadhi, the patient is connected to the healer consciously and the intention is directed to the patient in the form of no complication for the patient after surgery.

In a landmark study by Achterberg et al., using functional MRI on 11 recipients paired with 11 different healers of various DIH disciplines, found that the anterior and middle cingulated, frontal lobes and precuneus were activated by the healers in their recipients. [19] The anterior and middle cingulated are associated with control and decision making for verbal and motor responses. The frontal lobe is regarded as the information processing center, judgment and decision making. The precuneus is associated with a wide spectrum of highly integrated neural tasks including visiospatial imagery, episodic memory retrieval, self-processing operations and rest. It has been found that the posterior medial precuneus has one of the highest resting metabolic rates or hot spots in the brain. It has been hypothesized that selective hypometabolism in this area of the brain occurs during a wide range of altered states of consciousness such as sleep, drug induced anesthesia, and various vegetative states. [20] It is postulated that this highly integrated neuronal network connects the autonomic and endocrine systems during DIH enhancing its intention within the recipient.

Achterberg did not perform functional Magnification Resonance Imagery (fMRI) on the healers’ brain during the healing session. The various DIH techniques used in this study have not been extensively studied in terms of its efficacy and reliability, including the healers abilities.

Lastly, DIH-SHT benefits patients based on this study and others and may have more widespread applications such as augmenting other treatment modalities for various diseases such as cancer. The author will study via fMRI brain activity during SHT in both the healer and patients.

Conclusion

DIH-SHT is a real phenomena based on over 2,000 scientific studies including this one. [14] The DIH-SHT technique has demonstrated repeated efficacy in postoperative pain reduction, decreased postoperative use of narcotic analgesia and decreased complications following foot and ankle surgery. Furthermore, there is evidence from functional Magnification Resonance Imagery( fMRI) and other imaging devices that DIH-SHT affects certain parts of the “recipients’’ brain during the healing sessions.

There are other benefits using DIH-SHT technique such as no side effects, no toxicities, no complications and no deaths as a result of incorporating this modality in our postoperative management. This is a tremendous benefit that helps our patients reduce the cost of caring for expensive postoperative complications. This reduces or eliminates the burdensome medical care costs forcing patients into an untenable financial situation necessitating bankruptcy. Further studies of DIH-SHT will focus on fMRI studies on the healer’s brain during the healing session and a wider application on other diseases like diabetic foot ulcers and cancers for example.

Foot and ankle surgery poses less serious surgical risks than other surgeries based on this study. A majority of procedures were digital procedures which comparatively poses less risk to patients than abdominal surgery for example.

This skews the outcome and may be the reason for the low incidence of serious complications in foot and ankle surgeries contrasted to other major organ surgeries. However, I have seen patients lose their toes after simple digital surgeries including matrixectomies performed by other surgeons. Traumatic and careless tissue handling including compromise of the delicate circulatory network will result in loss of blood flow to the toe resulting in gangrene and eventual loss of the toe. Thus, all surgical procedures have some degree of risk to the patient including the simplest types to the most complex. Adding DIH-SHT postoperatively decreases the sequelae of complications and improves the surgical outcome significantly.

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19. Standish L, Johnson J, Clark L, Todd R, Kozak L, Richards T. Evidence of correlated fMRI signals between distant human brains. Alt Therapies in Health 2003 9: 122-128. [PubMed]
20. Achterberg J. Richards T, Salomie IA, Cooke K. Individual recipients’ functional brain changes during distant intentionality: a fMRI analysis. Presented at the North American Research Conference on Complementary and Integrative Medicine, May, 2006.
21. Lazar S, Bush G, Gollub RL, Fricchione GL, Khalsa G. Benson H. Autonomic Nervous System: Functional Brain Mapping of the Relaxation Response and Meditation. Lippincott,Williams & Wilkins, Inc. 2000.


Address correspondence to: Gerald T. Kuwada, DPM, NMD. 275 SW 41st Street, Renton, WA. 98057. Phone 425-251-9174, Fax 425-251-0758. Email: drgeraldkuwada@qwestoffice.net.

1  Private practice, 275 SW 41st street, Renton, WA 98057.

© The Foot and Ankle Online Journal, 2012

A Comparison of the Effects of First Metatarsophalangeal Joint Arthrodesis and Hemiarthroplasty on Function of Foot Forces using Gait Analysis

by Callaghan, M.J.1,2  ,Whitehouse, S.J., Baltzopoulos, V., Samarji, R.A.1

The Foot and Ankle Online Journal 4 (12): 1

Background: Arthroplasty or hemiarthroplasty for hallux rigidus of the first metatarsophalangeal (1st MTPJ) is thought to lead to greater joint motion and improved gait function. There have been no studies to compare the effects of 1st MTPJ arthrodesis and hemiarthroplasty on joint kinetics, kinematics and plantar pressures of foot and lower limb.
Methods: A retrospective, case series pilot study approximately 22 months post operation. Subjects had either arthrodesis or a NorthStar HemiCAP hemiarthroplasty for osteoarthritis of the 1st MTPJ. All had plantar pressure, kinetic and kinematic gait analysis as well as the Foot and Ankle Outcome Score (FAOS), and 1st MTPJ range of motion (ROM).
Results: For the hemiarthroplasty subjects the mean ROM on the non-operated 1st MTPJ was 490(SD23) but only190 (SD16) on the operated side. Kinetic and kinematic results for both operations were similar. Plantar peak pressure data showed that the arthrodesis group took more pressure under the 1st MTPJ in the stance phase. The arthrodesis group had higher FAOS scores (mean 95.6 SD 5.1) than the hemiarthroplasty group (mean 72.2 SD 18.8) indicating more satisfaction with their surgery.
Conclusions: Arthrodesis of the 1st MTPJ better FOAS scores, improved peak plantar pressure over the medial foot compared to a 1st MTPJ hemiarthroplasty. There were minimal differences in kinetic and kinematic data. Hemiarthroplasty patients had considerably reduced 1st MTPJ ROM compared to their non-operated side. We conclude that the North Star HemiCAP cannot be recommended at this time for the management of hallux rigidus. Arthrodesis remains the surgical treatment of choice.

Key Words: Monofilament,tuning fork,ankle reflex,superficial pain, neuropathy.

Accepted: November, 2011
Published: December, 2011

ISSN 1941-6806
doi: 10.3827/faoj.2011.0412.0001


First metatarsophalangeal joint (MTPJ) arthritis is a progressive, painful and debilitating condition also known as hallux rigidus. [1] The most common form of presentation is unilateral involvement in the older female patient with a gradual onset of pain and limited range of motion at the 1st MTPJ.

This often results in an abnormal gait pattern due to a shift in weight bearing from the first ray to the outer border of the foot [11] along the metatarsal heads transverse axis.

In a recent study on hallux rigidus [5] 90% of patients considered that their walking pattern had changed of which 33% considered that this change affected their everyday lives. Only 51 feet (28%) were able to push through the ground at propulsion, the remainder was affected to varying degrees of severity.

One hundred and thirty five feet (75%) rolled outwards during the propulsion phase of the gait cycle and it is claimed that these changes may be detrimental to a person’s gait.

Surgical treatments for hallux rigidus include arthrodesis, cheilectomy, excisional arthroplasty, metatarsal osteotomy, and total or hemiarthroplasty. Of these techniques, arthrodesis of the 1st MTPJ is regarded currently as the mainstay of surgical treatment [15], and is still considered the gold standard particularly in younger and more active patients. The technique is advocated for the alleviation of pain and deformity and restoration of the stability and weight bearing function of the first ray by stabilizing the medial column of the foot. [3,10] This technique has been shown to be successful both in pain relief and also in clinical and radiographic evaluation. [9] Despite the high patient satisfaction in terms of pain relief, 1st MTPJ arthrodesis has been shown to reduce functional gait parameters compared to the contralateral limb. For example, DeFrino et al., [6 ] using dynamic pedobarography on 10 feet, showed that 1st MTPJ arthrodesis produced a restoration of the weight bearing function of the first ray with greater maximum force carried by the distal hallux at toe-off. However, the same study also showed a statistically significant reduction in ankle torque and ankle power at push-off and a shorter step length and loss of ankle plantar flexion at toe-off. Similarly, Brodsky, et al., [3] compared pre and post operative arthrodesis data and found three statistically significant changes in gait: an increased single limb support time, a decrease in step length but an increase in maximum ankle push off power in contrast to the previous study. Although these finding were attributed to improvements in pain and mechanical stability, mechanics of the 1st MTPJ were not measured.

Stiffness resulting from an arthrodesis can lead to patient dissatisfaction with the arthrodesis technique. Normal gait patterns can be altered, with a decreased step length and some loss of ankle plantar flexion at toe-off on the fused side. [6] Additionally, the long term effects of a rigid first ray may not yet be apparent. [9]

An alternative and logical follow up is first MTPJ arthroplasty. Whether using a total or hemiarthroplasty, the aims of joint replacement are not only to provide pain relief but also restore motion of the first MTPJ, maintain joint stability with a concomitant improvement in function and gait. [12] Many different designs and solutions for arthroplasty have been proposed over time.

Evidence to support the increase in range of movement and improved gait is scanty and to date there has only been one randomized, controlled trial comparing arthrodesis to arthroplasty for hallux rigidus.   [9] This study compared 38 toes undergoing arthrodesis with 39 undergoing a Biomet unconstrained total arthroplasty. Pain was measured via a visual analogue scale (VAS) as well as patient self reported satisfaction, first MTPJ mobility using electrogoniometry and plantar foot pressures using pedobarography. The results showed that the arthrodesis group was statistically better in pain at 12 (p = 0.005) and 24 months (p = 0.01). First MTPJ range of motion in the arthroplasty group improved post operatively compared to the pre operative status, but not to a level of statistical significance. Gait analysis on an 8 meter walkway measured plantar foot pressures and showed that patients in both groups tended to weight bear on the lateral border of the foot. In the arthrodesis group, all fusion sites were united and had gained a significant improvement in pain levels. The authors were not in favor of total arthroplasty as several implants had to be removed due to loosening. They were not able to assess the effects of either procedures on other joints of the foot and ankle during walking due to the lack of kinetic and kinematic analysis.

A recent non-randomized retrospective study [13] compared the BioPro metallic hemiarthroplasty in 21 toes to first MTPJ arthrodesis in 27 toes and at 6 year follow up found inferior clinical and functional results in the arthroplasty group as assessed by the AOFAS Hallux Metatarsal Interphalangeal (AOFAS-HMI) score. There was no gait analysis of any kind performed.

Despite the theory that an arthroplasty would lead to greater first MTPJ motion and an improvement in gait function, there have been no studies to compare the effects of first MTPJ arthrodesis and hemiarthroplasty on both the joint kinetics and kinematics of foot and lower limb using gait analysis. These techniques combined in a specialist gait laboratory form a powerful and robust analysis of gait, joint mobility and muscle function. They would help our understanding of both procedures by providing information to assess the effects of each procedure on the other joints of the forefoot and gait mechanics and function in general, which are important for the long term prognosis of these techniques. We have identified some methodological issues arising from the studies cited: Firstly, there has been no gait analysis comparison of hemiarthroplasty with arthrodesis of the first MTPJ and their effects on foot and ankle kinetics and kinematics. Secondly, there has been no detailed analysis comparing the plantar pressure distribution of arthrodesis and hemiarthroplasty.

Therefore, the aims of this study were to observe any differences in kinematic, kinetic and plantar pressure measurements between first MTPJ hemiarthroplasty and first MTPJ arthrodesis. The study design took the form of a pilot study to ascertain technical feasibility and also to provide data exploring clinical significance and sample size for a future randomized controlled surgical trial.

Methods

This was a retrospective, case series pilot study.

Subjects

All patients were identified from the patient operating list of the senior surgeon (RAS) and had surgery for non- inflammatory, symptomatic hallux rigidus. There were five patients (4 females) with first MTPJ arthrodesis (Age 58.2 ± 15 years, mass 70 ±7kg and height 164 ±8cm) and four female patients with first MTPJ hemiarthroplasty (Age 60.5 ± 7 years, mass 68±6 kg, height 159±3 cm). Descriptive statistics are listed in Table 1. The mean post operation time was 23 months after arthrodesis and 22 months after hemiarthroplasty. None of the subjects had experienced any post-operative complications such as superficial or deep infection, deep venous thrombosis, or complex regional pain syndrome. There were no cases of non-union or component loosening and none of the arthrodeses or hemiarthroplasties had been revised.

Table 1   Descriptive statistics of subjects.

Exclusion Criteria

Subjects were excluded from the study if they had undergone other foot and ankle surgery, other degenerative joint diseases of the lower limb, post infectious arthritis, rheumatoid arthritis or Charcot neuroarthropathy.

Surgical procedures

First MTPJ hemiarthroplasty

A NorthStar HemiCAP implant MTP resurfacing implant was used for all hemiarthroplasty patients. (Figure 1A and 1B) First, a dorsal approach to the first MTPJ was used to expose the joint. A guide pin was inserted into the first metatarsal head via the distal articular surface using a drill guide to aid location of the correct axis. A cannulated drill was then used to drill over the guide wire. The hole was tapped and a taper post inserted. A trial cap was placed on the taper post to determine whether the correct depth has been achieved. The trial cap was removed and a centering shaft and contact probe inserted to determine offsets at four index points. The articular component size was determined from a sizing card using these offset values. A circle cutter was used over the guide pin to score the articular cartilage down to subchondral bone. A surface reamer, size matched to the chosen articular component was used next. A final sizing trial was inserted and any necessary adjustments made. Finally, the actual articular components was inserted and impacted down.

 

Figure 1A and 1B  Plain radiographs anterior posterior (A) and oblique (B) views of the NorthStar HemiCAP prosthesis.

Post operatively, no plaster cast was applied. Patients were encouraged to fully weight bear as soon as possible without walking aides. In particular, a normal gait pattern was permitted in order to achieve dorsiflexion at the MTPJ at the push off phase of the gait cycle. A check radiograph was requested 6 week post operatively.

First MTPJ Arthrodesis

The first MTPJ arthrodesis was carried out under tourniquet through a dorsal longitudinal incision centered over the metatarsophalangeal joint. (Figure 2A and 2B) The dorsal sensory nerve was seen and protected throughout the procedure. A capsulotomy was carried out and the metatarsal head and proximal phalanx were denuded of articular cartilage using reamers to expose bleeding cancellous bone. They were coapted and held with a partially threaded cancellous small fragment screw with a washer. The toe was positioned taking reference from the heel with slight dorsiflexion at the MTPJ in a neutral rotation and slight valgus position. The wound was closed in layers.

 

Figure 2A and 2B  Plain radiograph anterior posterior (A) and oblique (B) views of the arthrodesis technique.

Post operatively, patients were required to strictly heel weight bear with the help of walking aides for 6 weeks. A plaster slab was put over the operation site, but did not include the ankle or lateral border of the foot. Graduated heel weight bearing and discarding of the walking aides was permitted after a check radiograph 6 weeks post operation.

Outcome Measures

The foot and ankle outcome score (FAOS)

The FAOS [14] is a patient administered score consisting of 5 subscales; i) pain, ii) other Symptoms, iii) function in daily living (ADL), iv) function in sport and recreation (Sport/Rec), and v) foot and ankle-related Quality of Life (QOL). The last week was taken into consideration when answering the questionnaire. Standardized answer options were given (5 Likert boxes) and each question got a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) was calculated for each subscale. The results were plotted as an outcome profile.

MTPJ Range of motion

A small finger universal goniometer with five degree increments was used to measure first MTPJ range of motion (ROM) in dorsiflexion and plantarflexion. This was done in supine lying with the heel resting on the examination couch and the ankle in a neutral position.

Gait analysis

Gait analysis was performed on a 10 meter m instrumented walkway at the gait analysis laboratory at Manchester Metropolitan University. Kinematic and kinetic measurements and plantar pressures are affected by walking speed so participants were instructed to walk at their normal comfortable speed after familiarization with the testing procedures.

Kinematic data were acquired using a three-dimensional (3D) optoelectronic motion analysis system (VICON Nexus, Oxford Metrics, Oxford, England) with ten high-resolution cameras sampling at 120 Hz.

The kinematic data was filtered with cross-validating quintic splines interpolation (QSI scheme) to reduce the noise from skin movement and other sources of coordinate recording errors. The standard biomechanical foot model used in typical gait analysis applications represents the foot as a single rigid body, allowing the assessment of only foot progression angle and net dorsi/plantar flexion. This is not adequate for the purpose of this study and the examination of the MTPJ function. For this reason we used the “Oxford Foot model” [4] which represented the foot using three rigid segments (hindfoot, forefoot and hallux). The relative motion between the segments was described without inter-segment constraints in this foot model. This was necessary to accommodate the likely conditions and constraints of hallux and forefoot function in the patients of this study. For the hindfoot, segment markers were placed on the lateral and medial malleolus two markers along the vertical axis of the calcaneus posteriorly and two additional markers on the lateral and medial sides of the calcaneus. For the Forefoot and Hallux segments markers were placed on the distal medial side of the 1st MTPJ, the distal lateral side of the 5th metatarsal joint, on the distal 2nd MTPJ, on the proximal 1st and 5th MTPJ, and two markers (proximal and distal) on the long axis of the hallux. For the other leg segments the standard Helen Hayes marker set was used as implemented in the Bodybuilder modeling package of the VICON system. Static trials were performed before the gait tests to allow the calculation of segment-embedded coordinate frames based on the positions of the anatomical landmarks that were identified from the coordinates of the surface markers and relevant subject anthropometric measurements. Kinematic parameters to include joint angles and kinetic measures including joint moments and plantar pressures were calculated at key moments in the stance phase of gait cycle (heel strike, foot flat, midstance, heel off and toe off) for comparisons between the operated and unaffected side of the two different groups of patients.

Kinetic (ground reaction force) data were collected at 1080 Hz using two Kistler force-plates (Kistler, Switzerland) that are embedded in the middle of the walkway.

Joint kinetics (resultant joint forces and moments) were calculated using standard inverse dynamics techniques by combining the kinematic and force plate data into a musculoskeletal mechanical model of the lower limbs. Data were normalized to body weight.

Plantar pressures were recorded during level walking with the participants wearing their own shoes. The Tekscan in-shoe plantar pressure system was used for these measurements (Tekscan, Boston, MA), sampling at a frequency of 40 Hz. The Tekscan Research Foot software was used to construct individual ‘‘masks’’ to determine maximum force (kg) and peak pressure (kg/cm2) under several regions of interest of the foot including the hallux, toes, metatarsals, midfoot and heel.
The pressures in the plantar surface of the foot during normal gait were examined with Tekscan in-shoe plantar pressure system using the F-Scan sensors (Model #3000E VersaTek). These sensors contain up to 960 individual pressure sensing elements, that which detect the subject’s plantar pressure.

These pressure elements are arranged in rows and columns on the sensor and their output recorded by the system during any activity is quantified into 256 increments. This digital value is then calibrated for pressure in kilopascals (KPa). The sensors were cut to size for each subject and were inserted in the shoes so that the pressures exerted between the foot and the shoe were recorded during the gait.

A “step” calibration procedure was followed where the subject is required to shift the weight to each foot in turn so that the full weight of the subject is sensed alternately by both sensors (left and right). According to the instructions of the manufacturer, this is the most appropriate calibration technique for dynamic activities such as gait because it contains a factor for rapid dynamic changes and compensates for time related changes in sensor output. Following the calibration procedure, the subjects were asked to walk in their normal gait speed on a flat gait walkway of approximately 10 meters, three times. The first two trials were used for familiarization with the instrumentation in the shoes and although data were collected from all three trials only the third (final) trial was analyzed.

Statistical Analysis

The analysis was in two parts. Firstly, there was a within groups comparison of the kinetic, kinematic and plantar pressure parameters at key moments of the gait cycle between the operated and non-operated side of each patient. Secondly, there was a between groups analysis of the same parameters between the arthrodesis and hemiarthroplasty patients. The small sample size precluded the use of formal statistical analysis. Comparison of the other data sets was made by analysis of the descriptive statistics and normalized data.

Results

There were no adverse events from the gait analysis protocol.
The ROM for the 1st MTPJ measured by goniometry was 190 (SD16) for the hemiarthroplasty side were compared to 490(SD23) on the non-operated side. Figure 3 shows the differences in the post-operative ROM at 22 months.

Figure 3  Range of motion (ROM) at 1st MTPJ compared to non-operated side in hemi -arthroplasty patients.

The kinematic results are for the Oxford foot model maximum dorsiflexion and total ROM angles at the ankle and ROM at the 1st MTPJ. For the hemiarthroplasty patients the ROM angle at the 1st MTPJ was small compared to the non-operated side.

There was some measurable motion on the arthrodesis side which was smaller than the hemiarthroplasty. Reasons for the apparent contradiction of available motion in a fused joint are in the discussion. Ankle maximum ROM for dorsiflexion and total ROM were greater in the hemiarthroplasty side compared to the non-operated side and compared to the arthrodesis subjects. (see Table 2).

Table 2  Kinetic and kinematic data Means and (SD).  Legend: Max DF  =  maximum dorsiflexion, 1st MTPJ RoM = first metatarsophalangeal joint range of motion, % BW = percentage body weight.

The kinetic results from the force plate are for the peak medio-lateral force which is affected mainly by supination and pronation of the foot and ankle during the gait cycle from ‘heel strike’ to ‘toe off’. A higher ground reaction force in the lateral direction indicated more weight bearing on the medial side of the foot and the first ray. Compared to the non-operated side, the peak lateral force for both the arthrodesis and hemiarthroplasty sides was similar and slightly higher than the operated side. (see Table 2).

Table 3  Plantar Peak Pressure data for arthrodesis, hemiarthroplasty and non-operated foot. kPa means (SD).

The peak plantar pressures from the 1st MTPJ area are presented in Figure 4. The descriptive statistics are in Table 3. These data have several features. The peak plantar pressure area under the first metatarsal was higher on the arthrodesis side compared to the non-operated side (305 (SD 143 KPa) v 194 (SD 73 KPa)) indicating that this part of the foot was taking more pressure than those patients who had a hemiarthroplasty.

Figure 4  Mean Peak area plantar pressures under the first metatarsal head.

Furthermore, Table 3 shows that there was a tendency to take greater pressure on the 3rd, 4th, 5th metatarsal heads and the lateral side of the foot in the hemiarthroplasty patients. These data are illustrated in Figure 5 which shows a comparison between left side (normal) and right MTPJ arthrodesis and in Figure 6 which compares left (normal) and right MTPJ hemiarthroplasty. The differences between the plantar pressures at the first metatarsal area were difficult to assess through formal statistical analysis due to the small sample size.

Figure 5   Average peak stance data with center of force trajectory.  Patient was 24 months post right arthrodesis.

Figure 6  Average peak stance data with center of force trajectory.  The patient was 17 months post hemi-arthroplasty.

The FAOS scores are presented in Figure 7. These show that the arthrodesis patients (mean 95.6 (SD 5.1) scored higher in most of the subscales and on the overall score than those who had the hemiarthroplasty, (mean 72.2 (SD 18.8)

Figure 7   Foot and Ankle Outcome Score (FAOS).  Red = hemiarthroplasty, Blue = arthrodesis, 100 = normal FAOS score.

Discussion

This study aimed to compare a small group of subjects who had undergone arthrodesis or hemiarthroplasty using the NorthStar HemiCAP prosthesis for hallux rigidus using several gait parameters. Our study had volunteers whose mean post operation time was at least 22 months, thus giving a good representation of the long term outcome of both surgical techniques.

Arthrodesis is generally considered a satisfactory operation for primary OA of the 1st MTPJ. The functional excellence and durability of the results obtained are impressive, although the loss of 1st MTPJ range of motion is an obvious drawback of the technique. [7] The value of prosthetic implants instead is still a theme for debate. The advantages of the procedure include preservation of the motion and a wide variety of implants have been proposed over time. [8] Nevertheless high risk of failure of the implant and serious complications have been reported. [6] The aims of this study were to compare one surgeon experienced in both techniques, to assess clinical efficacy and to use gait analysis methods to help explain any differences between the two operations.

The kinematic results indicated that hemiarthroplasty gave only a minimally improved ROM at the hallux, although there was greater movement for maximum ankle dorsiflexion. The discrepancy concerning detectable movement at the fused MTPJ is most probably due to movement of the skin and the markers used for the kinematic analysis relative to the bones.

The kinetic results showed that both techniques resulted in similar laterally directed forces in mid stance.

These data indicate that after both arthrodesis and hemiarthroplasty more force can be taken on the inside of the foot compared to the non-operated side. This is in contrast to the observations from the more detailed plantar pressure data which show increased medial foot and 1st MTPJ pressure after the arthrodesis, but not after hemiarthroplasty. It is tempting to infer that this was due to them having less pain at the fused joint and therefore having few problems assuming a normal gait.

This is the first study to use insole sensors to compare plantar pressures of arthrodesis and hemiarthroplasty of the 1st MTPJ. The plantar pressure results showed that the arthrodesis patients were adopting a gait which favored normal 1st MTPJ pressures, whereas the hemiarthroplasty patients, even 22 months post operation, were still favoring the lateral side toes and avoiding pressure under the 1st MTPJ.

These data also show the advantages of plantar pressure and the limitations of ground reaction force analysis in the context of this investigation. Plantar pressure techniques are able to capture more precisely the focal points of pressure distribution (see Figures 5 and 6) whereas force plate readings present a more generalized indication of the overall ground reaction forces generated during gait.

The FAOS shows that all the patients who had hemiarthroplasty were not satisfied with their operation and had continuing pain and stiffness in their toes and foot. Interestingly, only one patient who had arthrodesis considered that foot stiffness was a problem. Four out of five arthrodesis patients considered themselves pain free (i.e.) scoring ‘normal’ on the pain subscale) whereas only one in four of the hemiarthroplasty group considered themselves pain free.

These results are similar to the data from Raikin, et al., [13] comparing 1st MTPJ arthrodesis with the BioPro metallic implant. Post-operative scores (using the invalidated American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal Interphalangeal -AOFAS-HMI scoring system) of 93 for arthrodesis and 71.8 for hemiarthroplasty are very similar to our FAOS of 95.6 and 72.5 respectively. These two sets of results suggest that arthrodesis is superior to hemiarthroplasty in terms of patient self reporting of pain, function and stiffness. This is also the conclusion of systematic review which concluded that arthrodesis achieved better functional outcomes than hemiarthroplasty. [2]

The poor outcome using FAOS might explain why the first metatarsal pressure was always higher in the arthrodesis group. It seems that patients felt sufficiently pain free and confident enough to take pressure through this area of the foot. Our results on the arthrodesis patients concur with DeFrino, et al., [6] who also measured plantar pressures on 10 feet, to show that first MTPJ arthrodesis produced a restoration of the weight bearing function of the first ray with greater maximum force carried by the distal hallux at toe-off.

There are few comparative studies in the literature and none involving the NorthStar HemiCAP. This is the first data presented for this implant. Gibson & Thompson [9] compared a Biomet unconstrained total arthroplasty to arthrodesis.

Like these researchers, we found that the arthrodesis group had better pain scores at 24 months, although we used a FAOS rather than the VAS. Their gait analysis showed that patients in both groups tended to weight bear on the lateral border of the foot, whereas our plantar pressure and kinetic data showed a tendency for lateral foot pressure to be greater in the arthroplasty patients, with arthrodesis patients having increased pressure (and therefore increased weight bearing) under the medial foot and 1st MTPJ.

Limitations

This study had some shortcomings. Patients were assessed retrospectively rather than prospectively, which may have affected preoperative scoring as it was based on chart review. Surgical treatment was not randomized, but was based on clinical need including patient’s preference with one surgeon performing the hemiarthroplasties and arthrodeses. The sample size was limited due to the number of NorthStar HemiCAPs which were performed and could be matched to an arthrodesis procedure.

Barefoot walking was preferred to standardized footwear for kinetic and kinematic analysis. This was decided due to the difficulty in obtaining funding for such footwear. However, all plantar pressure data used the patients’ own footwear in order to incorporate the insoles and this lack of standardization might be a confounding variable.

Conclusion

Arthrodesis of the 1st MTPJ results in better FOAS scores, improved peak plantar pressure over the medial foot compared to a 1st MTPJ hemiarthroplasty. There were minimal differences in kinetic and kinematic data. In the hemiarthroplasty patients, 1st MTPJ ROM was considerably reduced compared to their no-operated side.

Our results of the North Star HemiCAP concur with other studies using different implants that hemiarthroplasty cannot be recommended at this time for the management of hallux rigidus. Arthrodesis remains the surgical treatment of choice.

References

1. Coughlin MJ. Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. JBJS 2003 85A: 2072-2088.
2. Brewster M. Does total joint replacement or arthrodesis of the first metatarsophalangeal joint yield better functional results? A
systematic review of the literature. J Foot Ankle Surg 2010 49: 546-552.
3. Brodsky JW, Baum BS, Pollo FE, Mehta H. Prospective gait analysis in patients with first metatarsophalangeal joint arthrodesis for hallux rigidus. Foot Ankle Int 2007 28: 162-165.
4. Carson MC, Harrington ME, Thompson N, O’Connor JJ, Theologis TN. Kinematic analysis of a multi-segment foot model for research and clinical applications: a repeatability analysis. J Biomech 2001 34: 1299-1307.
5. Beeson P, Phillips C, Corr S, Ribbans WJ. Hallux rigidus: a cross-sectional study to evaluate clinical parameters. Foot 2009 19: 80-92.
6. DeFrino PF, Brodsky JW, Pollo FE, Crenshaw SJ, Beischer AD. First metatarsophalangeal arthrodesis: a clinical, pedobarographic and gait analysis study. Foot Ankle Int 2002 23: 496-502.
7. Fitzgerald JA. Wilkinson JM. Arthrodesis of the metatarsophalangeal joint of the great toe. Clin Orthop Rel Res 1981, 70-77.
8. Giannini S, Vannini F, Bevoni R, Francesconi D. Hallux Rigidus: Arthroplasty or not? G. Bentley (ed.), European Instructional Lectures. European Instructional Course Lectures 9, pages 239-246.
9. Gibson JN. Thomson CE. Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial. Foot
Ankle Int 2005 26: 680-690.
10. Kitaoka HB, Holiday AD, Jr., Chao EY, Cahalan TD. Salvage of failed first metatarsophalangeal joint implant arthroplasty by implant removal and synovectomy: clinical and biomechanical evaluation. Foot Ankle 1992 13: 243-250.
11. Mann RA, Coughlin MJ, DuVries HL. Hallux rigidus: A review of the literature and a method of treatment. Clin Orthop Rel Res 1979 57-63.
12. Olms K. Dietze A. Replacement arthroplasty for hallux rigidus. 21 patients with a 2-year follow-up. Int Orthopaedics 1999 23: 240-243.
13. Raikin SM, Ahmad J, Pour AE, Abidi N. Comparison of arthrodesis and metallic hemiarthroplasty of the hallux metatarsophalangeal joint. JBJS 2007; 89: 1979-1985.
14. Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int 2001 22: 788-794.
15. Vanore JV, Christensen JC, Kravitz SR, Schuberth JM, Thomas JL, Weil LS, Zlotoff HJ, Mendicino RW, Couture SD. Diagnosis and treatment of first metatarsophalangeal joint disorders. Section 2: Hallux Rigidus. J Foot Ankle Surg 2003 42: 124-136.


Address correspondence to: Michael Callighan, Manchester Royal Infirmary, Manchester,UK. E-mail: michael.callaghan@manchester.ac.uk

1  Manchester Royal Infirmary, Grafton Street, Manchester, UK.
2  University of Manchester, Oxford Road Manchester, UK.
3  Manchester Metropolitan University, John Dalton Building Manchester, UK.

© The Foot and Ankle Online Journal, 2011

Simple Screening Tests for Peripheral Neuropathy as a Prediction of Diabetic Foot Ulceration

by Ghada M. Morshed MRCS, MD1, Mohamed A. Mashahit MD2, Hala A. Shaheen, MD3

The Foot and Ankle Online Journal 4 (11): 2

Background and Objectives: Diabetes mellitus is one of the major health problems, and one of its commonest complications is peripheral neuropathy. The aim of this study is to evaluate four standard simple screening tests (10-g Semmes-Weinstein monofilament examination {SWME}, vibration sensation by a 128Hz tuning fork, superficial pain test and ankle reflex) for detection of neuropathy using the nerve conduction study ( NCSs) as the standard criterion in diabetic patients.

Methods: The study included 120 patients with diabetes mellitus, all patients had complete clinical assessment including presence or absence of neuropathy, exclusion of other causes of neuropathy, NCS,10 g Semmes-Weinstein monofilament examination, vibration sensation by a 128 Hz tuning fork ,superficial pain sensation and ankle reflex were done for all patients.

Results: Foot care practices were followed by 80 (66.6%) of the study population. When compared with NCSs, the monofilament was the most specific at 91%, less sensitive 57%, superficial pain, ankle reflex had lower specificity (36%, 41%) respectively, sensitivity (62%,57%) respectively. Tuning fork had specificity 90%, sensitivity 56%.

Conclusion: The study findings show that the simple screening tests (10-g SWME, vibration testing ,superficial pain test and ankle reflex) can be used confidently for annual screening of diabetic neuropathy in diabetic patients.

Key Words: Monofilament-tuning fork-ankle reflex-superficial pain-neuropathy.

Accepted: October, 2011
Published: November, 2011

ISSN 1941-6806
doi: 10.3827/faoj.2011.0411.0002


Diabetes mellitus is considered as a major health problem and one of its commonest complications involves the feet. Diabetic foot problems may lead to lower limb amputation which occurs commonly in uncontrolled diabetics. The chronic peripheral neuropathy which is associated with diabetes presents progressively and insidiously with poor symptoms related to the pathological severity. [1,2]

Peripheral neuropathy initiates the pathophysiology to leg ulceration and may be amputation and it is the main cause for sensory ataxia, painful paresthesia, and Charcot deformity. [3] Early identification and screening of neuropathy offer an important opportunity for the diabetic patient to actively alter the suboptimal glycemic control and improve foot care prior to significant morbidity. [4] Electrophysiological studies have shown the relation between glycated hemoglobin and the presence and also the severity of neuropathy. [5]

The aim of this study is to evaluate four standard simple screening tests (10-g Semmes-Weinstein monofilament examination {SWME}, vibration sensation by a128 Hz tuning fork, ankle reflex and superficial pain test) for detection of neuropathy using the NCSs as the standard criterion in diabetic patients.

Patient and Methods

Our study included 120 diabetic patients between March 2010 to July 2011, history taking of duration of diabetes, associated diseases, presence or absence of neuropathy (e.g. foot pain, tingling, numbness, imbalance, weakness and upper limb symptoms) and its duration if present, and they were examined as follows:

1. Exclusion of other causes of neuropathy (e.g. familial, nutritional, uremic, and alcoholic) by comprehensive examination medically and neurologically.
2. Standardized NCSs (bilateral) including motor (tibial, peroneal, median, and ulnar) and sensory (sural, median, and ulnar) nerves –performed by a blinded technicians to the status of the patient.
3. A10-g SWME (Fig. 1) superficial pain and vibration sense by a 128 Hz tuning fork (Fig. 2a,b) and ankle reflex, all were performed by a third examiner who is blinded to the history, physical examination and the results of NCSs.

Figure 1 10 gram sensory monofilament.

Figure 2a and 2b  128 hz tuning fork.

All data were entered on standardized forms, subjects identification was by number, date of birth, and initials.

Sensory testing methods

The patient was given a reference sensation by application of the stimulus to the sternum and then asked the nature of the sensation perceived. When the nature of the sensation was perceived accurately on the sternum, the patient was asked, with eyes closed, to describe the sensations experienced sequentially at the sites described below:

The SWME was conducted using a 10-g monofilament applied to a no callused site on the dorsum of the first toe just proximal to the nail bed. It was repeated four times on both feet in an arrhythmic manner. The SWME threshold was defined as the total number of times the application of 10-g monofilament was not perceived by the patient, and it varied from 0 to 8.

Vibration testing by a 128-Hz tuning fork applied to the bony prominence bilaterally situated at the dorsum of the first toe just proximal to the nail bed. The patient was asked to report the time at which vibration diminished beyond perception. The tuning fork was then applied to the dorsal aspect of the distal phalanx of the examiner’s thumb. The time (in seconds) at which vibration sensation diminished beyond the examiner’s perception was then recorded on a standardized form. The values from both sides were added to provide a single score for statistical analyses. The vibration test threshold was defined as the total number of times the application of the vibrating tuning fork and the dampening of vibration was not felt, with scores varying between 0 and 8.

Superficial pain sensation was conducted using a sterile NeurotipTM (Owen Mumford) applied four times to the two sites described in SWME. The superficial pain threshold was defined as the total number of times the application of the pain sensation was not perceived, with scores varying from 0 to 8. Ankle reflex was assessed with a tendon hammer and was recorded as either present or absent.

Criterion standard

Standardized techniques for NCSs were applied with temperature control and fixed distances. Measurements of latencies, distances, and amplitudes were assessed in a standard fashion using onset latencies and baseline to peak amplitudes. Initial positive peak (if present) to negative peak measurements were conducted for sensory responses. F waves were generated for all motor nerves, and minimal, reproducible latencies were measured. Conduction velocities were calculated for motor and sensory nerves.

All conduction velocity and distal amplitude values for the NCSs were given a score of 0 for normal and 1 for abnormal. The mean reference values+-2SD were taken as the normal range. The maximum NCS score if all parameters were abnormal was 28 points (16 motor and 12 sensory).The total NCS score was defined as the sum of the number of abnormal values.

Statistical analyses

The data were analyzed and we used the X2 test to detect the difference of results across the four tests compared to NCSs, P<0.01 was considered statistically significant. By constructing Receiver operating characteristic curve, sensitivity, specificity, positive and negative predictive values were calculated for the various tests using NCS as the gold standard definition of neuropathy.

Results

The study included 120 diabetic patients .The mean age was 52.2±4.8 (range 22-85years), 59 males (49.2%), 61 females (50.8%). In the study all patients had type2diabetes, the mean duration of diabetes was 8.21±7.81 years and mean FPG 202.15±50.44 mg/dl, 80.2% were receiving oral hypoglycemic drugs, 19.8% were receiving insulin .Foot care practices were followed by 80 (66.6%) patients of the study population by optimization of the glycemic control, cessation of smoking, prescription of adequate proper fit foot wear with wide deep box and debridement of calluses with follow up at 6 months and 12 months.

Evaluation of neuropathy by nerve conduction study (NCSs) showed peripheral neuropathy in 75 patients (62.5%), using other testing modalities neuropathy was found in 56 (46.6%) patients with monofilament, in 45 (37.5%) with superficial pain test, in 57 (47.5%) with vibration test and in 56 (46.6 %) with ankle reflex. Table 1 presents the sensitivity, specificity, PPV, NPV and P-value of each diagnostic test compared with NCSs which was taken as the gold standard.

Table 1  Sensitivity, specificity and P-value of the four tests.  PPV (positive predictive value), NPV (negative predictive value).

Discussion

In this study we used NCS as a standard criterion for the diagnosis of peripheral neuropathy. Since peripheral neuropathy is a main element in causing of both foot ulceration and amputation so selection of rapid, simple and accurate testing method for diagnosis of peripheral neuropathy in diabetic patients is so important and apart from NCS we select monofilament, superficial pain, tuning fork and ankle reflex for evaluation of peripheral neuropathy.

The most frequently used modality for peripheral neuropathy detection is the nylon Semmes-Weinstein monofilament. [7] Inability to perceive 10 g of force 5.07 monofilament applies is associated with clinically significant large-fiber neuropathy. In our study monofilament showed a sensitivity 57% and a specificity 91% compared to other studies with 95%sensitivity and 82% specificity, [8,9] other studies showed sensitivity of 77% and specificity 96% [6], also another study showed senility 66% and 34% specificity. [10]

The 128 Hz tuning fork in our study showed sensitivity of 56% and specificity of 90% compared to other study sensitivity and specificity was 53% and 99% respectively. The superficial pain test in our study showed sensitivity and specificity of 62% and 36% respectively 59% and 97% respectively.[6] The ankle reflex in our study showed sensitivity and specificity of 57% and 41% respectively compared to other studies showed sensitivity and specificity of 75% and 89% respectively. [11]

Conclusion

In our study we found that the simple screening tests (10g SWME, vibrating test, superficial pain test and ankle reflex) can be used confidently for annual screening of diabetic neuropathy in diabetic patients.

References

1. Britland ST, Young RJ, Sharma AK, Clarke BF. Association of painful and painless diabetic polyneuropathy with different patterns of nerve fiber degeneration and regeneration. Diabetes 1990 39: 898-908.
2. Ochoa J. Positive sensory symptoms in neuropathy: mechanisms and aspects of treatment. In Peripheral Nerve Disorders, 2nd ed. Asbury A, Thomas P (Eds) Oxford, UK, Butterworth-Heinemann, 1995, pp 44-58.
3. Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation: basis for prevention. Diabetes Care 1990 13: 513-521.
4. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Eng J Med 1993 329: 977-986.
5. Tkac I, Bril V. Glycemic control is related to the electrophysiologic severity of diabetic peripheral sensorimotor polyneuropathy. Diabetes Care 1998 21: 1749-1752.
6. Perkins BA, Olaleye D, Zinman B, Bril V. Simple screening tests for peripheral neuropathy in the diabetes clinic. Diabetes Care 2001 24: 250-256.
7. Armstrong DG. The 10-g monofilament: the diagnostic divining rod for the diabetic foot? Diabetes Care 2000 23: 984-988.
8. Armstrong DG, Lavery LA, Vela SA, Quebedeaux TL, Fleischli JG. Choosing a practical screening instrument to identify patients at risk for diabetic foot ulceration. Arch Intern Med 1998 158: 289-292.
9. de Sonnaville JJ, Colly JLP, Wijkel D, Heine RJ. The prevalence and determinants of foot ulceration in type II diabetic patients in a primary health care setting. Diabetes Res Clin Pract 1997 35: 149-156.
10. Boyko EJ, Ahroni JH, Stensel V, Forsberg RC, Davignon DR, Smith DG. A prospective study of risk factors for diabetic foot ulcer. The Seattle Diabetic Foot Study. Diabetes Care 1999 22: 1036-1042.
11. Tre GS, Lisbô HR, Syllo R, Canan LH, Gros JL. Prevalence and characteristics of diabetic polyneuropathy in Passo Fundo, South of Brazil. Arq Bras [Endocrinol] Metabol 2007 51: 987-992.


Address correspondence to: Ghada Morshed Ahmed Morshed, Galal El Deen El Seuty, El Manial, Cairo, Egypt. E-mail: ghadamorshed@yahoo.com. Tel: 0125870476

1,2,3  Departments of Surgery1, Internal Medicine2 and Neurology3. Faculty of Medicine, Fayoum University, Cairo, Egypt.

© The Foot and Ankle Online Journal, 2011

Delayed Primary Closure of Diabetic Foot Wounds using the DermaClose™ RC Tissue Expander

by David L. Nielson, DPM1, Stephanie C. Wu, DPM, MSc2, David G. Armstrong, DPM, PhD3

The Foot & Ankle Journal 1(2):3

Closure of large wounds has been a challenge in podiatric surgery, especially after large defects created by ulcer debridement, metatarsal resection and amputation. The DermaClose™ RC tissue expander allows for closure of large defects without the need for traditional complex skin closure, tissue grafting or creation of skin and tissue flaps. Skin anchors made of surgical steel clips are used with a tension controller to allow for gentle skin stretching on the subcutaneous planes of the wound or defect. It also has special application in the closure of chronic wounds. Two case reports are presented to describe this technique.

ISSN: 1941-6806/08/0102-0003
doi: 10.3827/faoj.2008.0102.0003

Mechanically assisted delayed primary closure of large foot wounds following emergency or ablative surgery will result in faster healing and assist in enhanced closure of a large tissue defect. The technique of rapid wound closure is enhanced with the use of the DermaClose™ RC tissue expanding device. The application of the device is simple and provides for a less complex treatment course than secondary wound closure.

Tissue expansion was first employed by placing straight wires (0.045-0.062) though the skin adjacent to the wound. Special ratcheting devices, suture, or 28 gauge wire are used to bring the straight wires closer thus exploiting stress relaxation inherent in skin. [1-4] A variety of companies make several devices to accomplish the same goal today. Mechanically assisted wounds have been shown to close up to 40% quicker than traditional secondary intention healing. [1]

When a wound is created, healing is either by primary closure if enough tissue is available or by secondary intention healing. Many times, in podiatry, large wounds and defects are created after ulcer debridement, metatarsal or bone resection and amputation. Secondary intention wound healing can be facilitated by a variety of modalities including local wound care, negative pressure vacuum therapy, hyperbaric therapy, tissue growth factors and application of bioengineered tissue equivalents. However, secondary intention healing of the defect often take weeks or months adding to the cost of wound and palliative care.

Delayed primary closure can also be challenging, especially in the foot. Many times this will include complex tissue closure, tissue grafts and adjacent tissue flaps to promote full wound closure.

The tissue expansion device now allows for rapid closure. It can also provide cost savings in respect to decreasing the need for prolonged wound care. We present two case reports describing the use of the DermaClose™ tissue expanding device.

Case #1

A 59 year old Caucasian male presents to our clinic with a chronic 3 year wound after a hallux and 2nd digital amputation. The patient has a long history of diabetes mellitus and has undergone kidney transplantation.

Application of the DermaClose™ device was initiated and it required about 3 months to close completely. The patient was taking immunosuppressive medication during this time, which may explain the prolonged closure rate.

The surgical site is thoroughly cleansed before application of the tissue anchors. A suture loop is then placed through the anchors and tension is applied by the device. In this case, a figure-8 suture was used to apply uniform tension perpendicular to the skin edges. (Fig.1)

Figure 1 Case #1 shows the patient post amputation with local dehiscence of the wound edges. Here, the DermaClose Clips are placed around the wound and the wound edges are approximated under tension. The suture is applied in a circular or figure-8 fashion. It is important to also protect the foot with foam from the overlying tension device.

Case #2

A 42 year old African-American male presents to our clinic after stepping on a bottle cap in March 2007. The patient is a poorly controlled diabetic with serum glucose running between 250 and 350 mg/dL. His medications include oral hypoglycemics, injectable Insulin and cholesterol lowering drugs. Unfortunately, he developed infection and underwent incision and drainage of deep space abscess with second partial metatarsal resection and digital amputation.

Prior to delayed closure and use of the DermaClose™ device, the patient underwent a series of wound care treatments, negative pressure wound VAC and application of Graft Jacket. After several months, the amputation site failed to close and a large, granulating defect remained. (Fig. 2)

Figure 2 Case #2 represents a large, chronic post-amputation defect.

In order to promote final closure, the DermaClose™ tissue expanding device was applied. Preparation of the wound consists of surgical debridement of all non-viable tissue. The wound edges are undermined about 2cm from the wound edge. (Fig. 3)

Figure 3 The wound must be surgically debrided of all non-viable tissue prior to application of the device. The device is applied and within 3 days the dorsal defect closed. Here, the anchors are tensioned in a shoe-lace fashion.

During the tension phase, the patient remained in a CAM boot and underwent daily dressing changes. Final closure of the defect was accomplished within just a few days of application. (Fig. 4,5)

Figure 4 Closure of the chronic wound using the DermaClose device.

Figure 5 Plantar view of the closed wound. A separate DermaClose device was applied plantarly.

Application

The device describe, (DermaClose™, Wound Care Technologies, Chanhassen, MN, USA) consist of skin anchors made of 316L surgical stainless steel and placed circumferential to the wound 1-1.5 cm from the wound edge.

The anchors penetrate the skin and into the subcutaneous tissue. Each anchor is held in place with two skin staples. A monofilament, high strength suture is then woven around each anchor.

The suture is then tightened to approximately 1.3kg of force, bringing the wound edges closer together. Once the dynamic tension is reached, additional tightening is not needed.

Patients should be seen every 3-5 days for evaluation of the device and the tissue movement. Care should be noted that the anchors do not envelop or imprint into the skin.

The DermaClose™ tension controller is attached around each skin anchor and the knob of the tension device is rotated until a clutch mechanism provides an audible indication that full tension has been achieved. The device now maintains the proper amount of tension to gently stretch the skin on the subcutaneous planes around the wound until the edges of the wound are brought close enough together for final suturing and closure.

Discussion

In both cases, the wounds are considered chronic, diabetic wounds. The rate of closure varied in case #1 due to immunosuppressive therapy. In general, the DermaClose™ device will provide rapid closure of an otherwise chronic or stagnant wound.

In one of the first studies to evaluate rates of mechanically assisted closure, Armstrong and Lavery reported that closure can be assisted approximately 40% faster than by secondary intension healing alone. [1]

Optimal results were obtained by strict off-loading of the foot during the tension phase of treatment, debridement with meticulous and frequent wound care. Armstrong and Lavery also identified the average healing time of a standard wound was similar to total contact casting.

Both cases represent a cross-sectional example of a small, chronic wound and a larger defect after amputation. Both responded favorably to mechanically induced delayed primary closure.

Conclusion

As one advances from the simple to the complex wound, the theoretical risk for complications increases. Therefore, specialist working in this area should always try to expand his or her armamentarium to assist in wound simplification and closure. Skin stretching devices are among some of these tools. At the Center for Lower Extremity Ambulatory Research (CLEAR), we are experiencing success in utilizing such devices to augment the closure of wounds. Members of CLEAR were amongst the first to evaluate this technique in the lower extremity more than a decade ago. We believe that the quality and breadth of these devices are improving. This can only benefit us as we move forward.

References

1. Armstrong DG, Lavery LA. Mechanically Assisted, Delayed Primary Closure of Diabetic Foot Wounds. JAPMA;88(10):483-488, 1998.
2. Armstrong DG, Sorensen JS, Bushman TB. Exploiting the viscoelastic properties of pedal skin with the sure-closure skin stretching device. JFAS;34(3):247-253, 1995.
3. Armstrong DG, Wunderlich RP, Lavery LA. Reaching closure with skin stretching. Applications in the diabetic foot. Clin Podiatr Med Surg;15(1):109-116, 1998.
4. Hirshowitz B, Lindenbaum E, Har-Shai Y. A skin-stretching device for the harnessing of the viscoelastic properties of skin. Plast Reconst Surg.;92:260-267, 1993.


1,2,3 Scholl’s Center for Lower Extremity Ambulatory Research (CLEAR) at Rosalind Franklin University of Medicine and Science.

© The Foot & Ankle Journal, 2008

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A Unique Method of Plantar Forefoot Ulcer Closure using the Ilizarov Device: Series of 11 Patients with Leprosy

by B. Jagannath Kamath, M.S. (Ortho)1 , Praveen Bhardwaj, M.S., (Ortho)2

The Foot & Ankle Journal 1(1):3

Introduction: Recurrent plantar ulcer is a common and serious problem of anesthetic feet in leprosy. There are many methods described in the literature to deal this problem, but it still remains a great challenge for the treating surgeon. The problem lies not only in attaining the coverage and healing of the ulcer but also to prevent its recurrence. The skin of the forefoot is a specialized one and hence procedures aimed at providing skin from elsewhere will tend to fail. The local flaps described in the literature are effective, but forms a major surgery for this group of patients, requires an expert to perform and are not devoid of complications, which if occur can be disastrous. We are herein describing a technique of closure of these forefoot ulcers, which makes use of the biomechanical properties of the skin and provided closure of these ulcers by slow and sustained stretching of the surrounding natural skin. It thus provides the specialized plantar skin coverage for the ulcers.

Method: We have used this technique in eleven leprosy patients with forefoot ulcers. Four patients had ulcers under the head of first metatarsal, four under the heads of first and second metatarsals, two under the second metatarsal head and one under the heads of fifth metatarsals. Size of the ulcers at its maximum length ranged from 2 – 4 cm.

Results: The technique successfully resulted in healing of all the ulcers without any significant complication. All the ulcers could be closed in ten days and all of them healed well within six weeks.

Conclusion: We found the technique to be very effective. It providing the specialized plantar skin for healing the ulcers is most attractive feature. The technique is simple and free of any major complication. The device used to achieve the closure is very inexpensive, can be easily made and is easy to use.

Key Words: Forefoot ulcers in leprosy; technique of closure; stretching; provides specialized skin cover; simple, inexpensive and effective.

ISSN: 1941-6806/08/0101-0003
doi: 10.3827/faoj.2008.0101.0003

Recurrent plantar ulceration is a frequently seen problem in anesthetic feet of leprosy. The seriousness of these ulcers lie in the fact that it can be difficult to keep the ulcers healed. Management of these chronic ulcers can be very frustrating for the patient and for those involved in their treatment. Ulcers occur in about 30 percent of the patients suffering with leprosy and are most commonly seen at the forefoot. [1] The factors contributing to the onset of these ulcers are impaired sensation, atrophy and fibrosis of muscles of foot and alteration of sympathetic enervation that in turn produces dryness, anhidrosis and hyperkeratosis. As the intrinsic muscles of the foot, which are secondary stabilizers of the metarsophalangeal joints become ineffective, it results in clawing of the toes making the heads of the metatarsals very prominent because of hyperextension of the metacarpophalangeal joints and flexion at the interphalangeal joints. Additionally, the loss of transverse and longitudinal arches of the foot increases the irregular distribution of the weight across the midfoot and metatarsal heads. Ulcers are more common on the plantar forefoot because this is where the greatest forces are concentrated. Ulcers are most common under the first metatarsal head; they also less commonly appear under the second and fifth metatarsal heads. The tissues in this area are highly specialized for the purpose of weight bearing and hence are difficult to reconstruct. [2] Any procedure to cover the defect in this area should ideally provide a stable local tissue. The distant flaps or free flaps described to cover these areas in our view fail because they lack the special architecture for absorbing impact and shear which the plantar skin is subjected to. Quite a number of local flaps are described to get the specialized plantar skin to cover the skin defects. [2-4]These flaps are quite successful, but are technically demanding as the plantar skin allows very little mobilization and if the flaps fail it leaves one in disastrous situation. Some skin stretching techniques have been described in recent past to close skin defects. [5-10]These techniques utilize viscoelastic properties of skin. Biomechanical properties of skin like mechanical creep, recruitment and stress relaxation allows the skin to stretch. We have used this ability of the skin to close the forefoot ulcers in leprosy patients. The technique described is simple, effective and inexpensive. It has given very satisfying results in our experience.

Materials and Methods

Patient selection is very crucial and may dictate the final results. We recommend the procedure for:

1. Ulcers which are not grossly infected
2. The ulcer should not be extending to the bone
3. Size of the ulcer should not exceed 4 cm
4. No diabetes mellitus
5. No peripheral vascular disease

We had eleven cases, which met the criteria mentioned above. Procedure was performed for all these patients; details are described in the table 1.

Case No.

Size of the Ulcer Site of the Ulcer(Under the Head of) Time taken for closure
1. 2 cm First metatarsal 5 days
2. 2.5 cm First metatarsal 5 days
3. 2.5 cm Fifth metatarsal 6 days
4. 3.5 cm First & second metatarsals 8 days
5. 3 cm Second metatarsal 8 days
6. 4 cm First, Second & third metatarsals 10 days
7. 3.5 cm First & second metatarsals 9 days
8. 4 cm First metatarsal 10 days
9. 2.5 cm Second metatarsal 7 days
10. 3.5cm First & second metatarsals 8 days
11. 3cm First metatarsal 8 days

Table 1: Patient details and time taken for ulcer closure.

Thorough debridement and freshening of the edges is mandatory as the highly keratinized scar tissue accompanies the plantar ulcers, which must be excised. We avoid excessive undermining of skin margins as this could risk their viability when a strong stretching force is employed for obtaining extra skin. Also K-wire assembly will be unstable if excessive undermining of the margins is done and may even make insertion of K-wires technically difficult.

Description of Device

The Ilizarov device consists of :

1. Two K-wires of size 1.5 to 1.8 mm. (Figure 1 A)
2. Two specially designed custom-made K-wire holding bolts, which are without any threads and are free to slide over the threaded rods. K-wires are transfixed to these bolts by using either inbuilt or external bolts as shown in the figure no.1. The corners of the bolts are rounded to prevent the sharp edges abrading the skin. (Figure 1 B)
3. Two threaded rods used in Ilizarov’s apparatus in Orthopedic surgery. (Figure 1 C)
4. Eight threaded bolts used in Ilizarov’s apparatus, which can be threaded on to the rod. (Figure 1 D)

Figure 1 Components of the device: A: K-wires; B: K-wire holding bolt; C: threaded rod; D: nuts.

Technique

An example of a forefoot ulcer is shown preoperatively. (Figure 2) The K-wires are passed on the either side of the ulcer at a distance of about one cm from the edge deep enough to engage in the dermis. (Figure 3) It is important to have the K-wires deep enough in the dermis and at equal depth throughout its extent to exert a strong and uniform approximating force. The K-wires are secured onto the K-wire holding bolts. (Figure 1 & 3) Threaded rods are passed into the K-wire holding bolts on both the sides and are secured in place by two threaded bolts on the outer aspect of each K-wire holding bolt. (Figure 3) These threaded bolts will thus approximate the K-wire holding bolts and hence the K-wires as they are tightened.

Figure 2 Preoperative photograph of a patient showing the ulcer present under the heads of metatarsals extending from base of first metatarsal to that of the third metatarsal.

Figure 3 Photograph taken after initial approximation of the wound as was easily possible in the early postoperative days.

We start approximating the wound on the first postoperative day. Each single turn of the threaded bolt causes the K-wires on either side to approximate the wound by 1mm on both sides and causing 2mm decrease in the wound size.

The speed of approximation depends of the skin condition, which is vigilantly monitored. Skin pallor, tautness of skin and shininess and excessive pain are the indicators of temporary stoppage of approximation process. Generally in the beginning we are able to approximate about 5-6 mm and gradually decrease it as the time passes by. In all the cases we have been able to achieve complete closure in 10 days or less. We have experienced that it is possible to achieve a greater degree of closure in medio-lateral direction than the antero-posterior direction. After approximation is achieved the skin edges are sutured and the fixator is maintained for another week. (Figure 4) The patient is kept non-weight bearing for another two weeks. Patients are then advised regarding foot care and hygiene and are asked to avoid static standing for more than 10 minutes at a time. Prevention of recurrence is very crucial. Secondary procedures like metatarsal osteotomy may be done if required to prevent recurrence once the ulcer is closed. (Figure 5)

Figure 4 Photograph after the complete approximation was achieved. At this point the edges are sutured together with a strong non-absorbable material.

Figure 5 Photograph of the same patient showing the ulcer completely closed.

Discussion

Treatment of ulcers in leprosy remains a challenge to the treating surgeon. The various options available are casts, modified foot wears, local flaps and distant flaps.

The non-operative methods are useful only in cases where the size of the ulcer is small and thus for larger ulcers surgery is the only option. The distant flaps fail to provide the specialized plantar skin and hence are likely to fail. The various local flaps described in the literature are quite handy but form a major surgical procedure requiring an expert to perform them and have grave consequence if they fail. The application and principle of gaining tissue by recruitment using force is not new and has been successfully applied to wound coverage problem for years. [5-10] Skin stretching results in significant histo-morphological changes in collagen fibers of the dermis and results in their rapid realigning in response to the stretching force and become aligned in the direction of the stretching force, perpendicular to the wound margin. [11]

Although the technique of tissue expansion was first reported by Newman as early as 1957, [12] it became more popular only after Randovan’s [13] description in 1982. In their experimental and clinical study Liang et al introduced the technique of pre-suturing. [8]

They described the properties of skin, which contribute to its expansion and can be used to close the skin defect. These include: inherent expansion, mechanical creep and biological creep. Inherent extensibility is defined as the excess skin that allows primary excision and closure. Mechanical creep is a biomechanical property of the skin, which allows it to gradually stretch beyond its limits; this is because of straightening of the normally randomly aligned collagen fibers. Biological creep is the property of skin to increase the tissue by mitotic activity, which has been demonstrated to occur within 24 to 48 hours in response to persistent expansion pressure. [14]

Tissue stretching procedures have been widely used, but its use for the sole of the foot has been infrequently reported. This is probably because of the thick plantar skin. Malaviya has described a technique of closure of simple heel ulcers by skin stretching. [15] This is an intraoperative technique in which two needles are places on either side of the ulcer and these needles are than approximated by passing sutures around these needles. This technique may be handy in case of small and superficial wounds only. The device designed by the authors has the strength required to approximate the thick plantar skin and has proved effective in closing ulcers as big as 4 cm. The thicker K-wires, which are passed in deeper dermis and are at equal depth throughout the length, provide a strong grip on the skin required for approximating the thick plantar skin. The device provides control on all the four corners of the wound by virtue of the K-wires. Each corner of the wound can be individually and independently subjected to skin stretching. This differential stretching is a very special feature of our device, which is not possible with any device described, even the patented devices marketed. If it is observed that the skin is becoming tight at any one place, the stretching can be stopped only at that place with continuing stretching to other areas. The compressing rods are on either side of the ulcer; contrary to many marketed stretching devices, which have the compressing rod transversing across the wound and allows for easy care of the ulcer.

The authors device initially uses the mechanical creep to bring about the coverage and probably after two days also induces biological creep accounting for the good results achieved in this report. A patented device-like “sure closure” costs more than 700 dollars per box, but our device will not cost more than a few dollars and can be easily made.

In conclusion, a rather simple solution to overcome otherwise complex situations of skin shortage has been described. We have found that addition of this technique to our armamentarium has effectively increased our options in closure of problematic forefoot plantar ulcers in leprosy.

References

1. Liwen D, Futian Li, Zaiming W, Juan J, Guocheng Z, Jinhu P, Jugen Z, Yongliang Y. Technique for covering soft tissue defects resulting from plantar ulcers in leprosy: Part I- General consideration and summary of results. Indian J Lepr, 1999; 71(3); 285-309.
2. Colen LB, Replogle SL, Mathes SJ. The V-Y flap for reconstruction of forefoot. Plastic Reconstr Surg, 1988; 81(2); 220-228.
3. Lennox WN. Plastic surgery of the anesthetic foot of leprosy. Lepr Rev, 1965; 36(3); 109-117.
4. Giraldo F, De Haro F, Ferrer A. Opposed transverse extended V-Y plantar flaps for reconstruction of neuropathic metatarsal head ulcers. Plastic Reconstr Surg, 2001; 108(4); 1019-1024.
5. Hirshowitz B, Lindenbaum E, Har-Shai Y. A skin-stretching device for the harnessing of the viscoelastic properties of skin. Plastic Reconstr Surg, 1993; 92(2); 260-269.
6. Stahl S, Har-Shai Y, Hirshowitz B. Closure of wound in the extremity using a skin stretching device. J Hand Surgery, 1996; 21B(4); 534-537.
7. Browne T. Closing a wide wound by using two stout spinal needles and three Allis forceps. Plastic Reconstr Surg, 1998; 101(4); 1159-1161.
8. Liang MD, Briggs P, Heckler FR, Futrell W. Presuturing- A new technique for closing large skin defects: Clinical and Experimental study. Plastic Reconstr Surg, 1988; 81(5); 694-703.
9. Concannon MJ, Puckett CL. Wound coverage using modified tissue expansion. Plastic Reconstr Surg, 1998; 102(2); 377-384.
10. Abenavoli FM. A simple tissue extensor. Plastic Reconstr Surg, 2002; 109(5); 1763-1764.
11. Melis P, Noorlander ML, van der Horst CMAM, van Noorden CJF. Rapid alignment of collagen fibers in the dermis of undermined and not undermined skin stretching with a skin-stretching device. Plastic Reconstr Surg, 2002; 109(2); 674-680.
12. Neumann CG. The expansion of an area of skin by progressive distention of a subcutaneous balloon. Plastic Reconstr Surg, 1957; 19; 124-128.
13. Radovan C. Breast reconstruction after mastectomy using the temporary expander. Plastic Reconstr Surg, 1982; 69; 185-202.
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Address correspondence to: Dr. B. Jagannath Kamath. Jyothi Mansion, Opposite Prabhat Theatre, K. S. Rao Road, Mangalore, India. Pin- 575001. Phone: 91-0824-2440233; Mobile: 91-9845235747
E-mail: bjkamath@satyam.net.in 

1Associate Professor of Orthopaedics, Kasturba Medical College, Mangalore, Karnataka, India.

2Assistant Professor of Orthopaedics, Kasturba Medical College, Mangalore, Karnataka, India.
E-MAIL: drpb12@yahoo.co.in

© The Foot & Ankle Journal , 2008

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