Tag Archives: hallux rigidus

Dextrose Prolotherapy with Human Growth Hormone to Treat Chronic First Metatarsophalangeal Joint Pain

by Ross A. Hauser, MD1, Wayne A. Feister, DO2

The Foot and Ankle Online Journal 5 (9): 1

The metatarsophalangeal joint (MTPJ), formed by the metatarsal and phalangeal bones of the toes, is the location of common foot pathologies. The two most prevalent sources of pain in the MTP joint are the conditions of hallux valgus, a precursor to bunions, and hallux rigidus, stiffness in the big toe. A well-researched etiology (cause) for these conditions is ligament laxity. In this study, twelve patients were treated with a series of Dextrose Prolotherapy injections to stimulate the regeneration of tendons and ligaments and to promote the repair of articular cartilage. Upon completion of three-to-six therapy sessions, eleven of twelve patients had a favorable outcome—the relief of symptoms—with an average of four treatments. Based on such positive, verifiable results, Hackett-Hemwall Dextrose Prolotherapy can be viewed as a promising alternative to steroid injection, surgical repositioning (e.g., chevron osteotomy), or joint replacement.

Keywords: metatarsophalangeal joint pain, hallux valgus (bunion), hallux rigidus, hypermobility, ligament laxity, Prolotherapy, and human growth hormone (hGH)

Accepted: August, 2012
Published: September, 2012

ISSN 1941-6806
doi: 10.3827/faoj.2012.0509.0001

Chronic foot pain has reached epidemic proportions in the United States with over 40 million people reporting problems in their feet.[1] A typical cause of foot pain is deformity in the first metatarsophalangeal (MTP) joint, commonly called a bunion. The American Academy of Orthopaedic Surgeons reports, “more than half of the women in America have bunions, a common deformity…” and “nine out of ten bunions happen to women.” According to the AAOS, bunions are one of the most widespread, chronic foot complaints addressed by foot and ankle specialists.

Surgical reconstruction of this joint, therefore, is one of the most prevalent joint surgeries performed on the foot.[2] The two most prevalent causes of pain in the MTP joint are the conditions of hallux valgus and hallux rigidus, with hallux valgus being more and hallux rigidus less frequent.[3, 4] Hallux valgus, specifically, is a deformity that occurs when the big toe angles toward the other toes (Fig. 1).

Figure 1 Shows the location and the appearance of a bunion. (Reproduced with permission)

This shift in the toe leads to the formation of a bunion, a boney projection on the medial side of the toe that attempts to stabilize joint motion.[2] (Fig. 2) In addition to hallux valgus, hallux rigidus also afflicts the MTP joint. Hallux rigidus is the condition caused by degenerating cartilage in the MTP joint, which eventually leads to osteophytes (bone spurs) forming around the joint—the body’s attempt to stabilize the joint. The bone growth associated with hallux valgus reduces movement in both flexion and extension (compare Fig. 3 and Fig. 4) and thus leads to hallux rigidus and potentially the worst outcome, a frozen joint.[5]

Figure 2 X-ray image of a bunion.

Figure 3 Shows normal function of the MTP joint, go to www.drfosdick.com

Figure 4 Shows hallux rigidus in MPT joint, go to www.drfosdick.com

Studies indicate that these painful foot conditions affect various groups differently. One study estimates that 33% of adults who wear shoes show some degree of hallux valgus.[6] Other studies report that women are affected in greater numbers than the general population. In one study, Dawson found that 38% of fifty- to seventy-year-old women have bunions, which directly result from hallux valgus.[7, 8] Hallux valgus especially afflicts the elderly. Using a sample of seventy-one adults from 75 to 93 years, Menz and Lord reported that 70% have hallux valgus.[2] Also, those with congenital ligament laxity, including patients with Down’s syndrome, may be more prone to hallux valgus.[9]

This painful foot condition compels patients to seek a variety of prescribed, available treatments. All the patients in this study had had some other form of therapy before Prolotherapy. Among conventional therapies, surgery is often prescribed for hallux valgus and the resulting bunions. Torkki notes “hallux valgus surgery is among the most common orthopedic operations in Western industrialized countries”; roughly 209,000 hallux valgus surgeries are done annually in the United States.[10] Not only is surgery on the first metatarsophalangeal joint common, but it is also the fourth most frequent surgery, preceded by operations on the knee, hip and lower back.[2]

Despite the prevalence of hallux valgus and the number of surgeries performed, there is no consensus on optimal treatment choices. Currently, there are over 130 operative techniques used to treat hallux valgus, including Chevron osteotomy (Fig. 5), distal metatarsal osteotomy, arthrodesis, and Keller’s arthroplasty.[8, 11] A 2004 Cochrane Systematic Review found that no surgical technique was superior to any other. The Cochrane Review also notes that few studies exist on the value and performance of conservative treatments, and those show orthotics and splints to be ineffective.[12] In another review, Maffulli states “Data are lacking to allow definitive conclusions on the use of these [minimally invasive] surgical techniques for routine management of patients with hallux valgus.”[13]

Figure 5 Chevron’s Osteotomy

Due to a lack of consensus on the efficacy of surgery and other conservative treatments, patients are considering alternative methods, including Prolotherapy. Because first MTP joint pain—a common orthopedic ailment—is difficult to manage, this study investigated Dextrose Prolotherapy injections in order to establish the efficacy of this treatment with a study group and, subsequently, with patients afflicted with several painful conditions.

The term Prolotherapy was coined in the early 1950s by a trauma surgeon from Canton, OH, George S. Hackett M.D. In the introduction to Ligament and Tendon Relaxation Treated by Prolotherapy, Prolotherapy is defined as “…a method of injection treatment designed to stimulate healing.” [14] Specifically, Prolotherapy utilizes a variety of irritants in solution that are injected into the ligaments, tendons, and joints to encourage repair of damaged tissues. In the preface to the third edition, Hackett describes Prolotherapy as strengthening “the weld of disabled ligaments and tendons to bone by stimulating the production of new bone and fibrous tissue cells….”[14] Modern scientific research has shown that Prolotherapy initiates inflammation, which increases blood flow and growth factors to the injected area, thereby stimulating fibroblast activity and eventual ligament and cartilage maturation.

Many studies confirm Prolotherapy’s widespread use with orthopedic pathologies. Dr. Hackett himself published many scientific articles showing the efficacy of Prolotherapy for such conditions as ligament laxity, chronic low back pain, sacroiliac dysfunction, cervical spine pain, etc….[15, 16, 17, 18, 19] One of Dr. Hackett’s students, Gustav Hemwall, extended Hackett’s work by utilizing Prolotherapy in chronic musculoskeletal conditions, including those of the foot.[14] While published peer-reviewed research has documented Prolotherapy’s effectiveness for many musculoskeletal conditions, including athletic osteitis pubis, sacroiliac pain, anterior cruciate tears, low back pain, osteoarthritis, lateral epicondylitis, Achilles tendinosis, and chronic foot pain, among others, no study has yet documented its success treating chronic big toe pain.[14, 20] For this reason, studies are beginning to report on the treatment of the big toe with Hemwall-Hackett Prolotherapy. [21, 22, 23, 24, 25, 26, 27]


This retrospective study collected data from twelve patients—4 males and 8 females, ranging in age from 30 to 60, mean age of 50—with hallux valgus. Of the patients studied, 100% had tried alternative treatments, among which were splints, orthotics, and surgery. Exclusion criteria included age: no one under 18 could be a study participant.

Patients complaining of diffuse big toe pain were treated with Prolotherapy. To prepare patients, their vital signs were recorded; medical histories were obtained and documented. The treatment process began with a patient assuming a supine position on the table. Then 5% Lidocaine cream was applied to the area to be injected 10 – 15 minutes prior to the treatment. Once this time lapsed, the cream was removed with 3% hydrogen peroxide.

After this preparation process, the area was cleaned with Chloraprep® (chlorhexidine gluconate 2% and isopropyl alcohol 70%). Then a 15% Dextrose, 0.1% procaine, 10% Sarapin solution was injected into the following areas: the capsular ligaments; sesamoid bones; base of first metatarsal bone; the attachments of these two tendons—abductor hallucis and flexor hallucis brevis—to bone; and first metatarsophalangeal ligaments.

Using aseptic techniques, a 10 mL syringe was filled with a solution of 12.5% Dextrose solution and 1 IU of human growth hormone (hGH) for injection into the first metatarsophalangeal joint (intraarticular). Before injecting, air was expelled from the syringe through a 22-gauge needle. Though volume varied slightly, approximately 1 mL was used per injection. In each treatment session, the anterior, posterior, medial, and lateral portions of the MTPJ were injected 8 times with approximately 10 cc of solution. After treatment, patients were left to rest under moist heat for 10 – 15 minutes. The heat was removed, and the patient’s toe was cleaned with 3% hydrogen peroxide.

In the days following the procedure, patients were allowed to return to normal non-strenuous activities. Patients were advised to avoid such medications as ibuprofen, which block the inflammatory process. However, we did approve of the use of acetaminophen-based analgesia. Patients returned for treatment every four weeks, depending on their schedule, completing from 3 – 6 treatments.


As for data collection, all twelve patients completed telephone follow-up within six months to two years, averaging 10.8 months after full treatment. In phone surveys, patients were asked to rate their toe stiffness, to record the number of pain pills taken, and to report any surgeries. Patients also assessed their own pain using Visual Analog Scale (VAS) scores, rating their pain from 0 to 10, 0 being no pain and 10 being constant, excruciating pain.

Using Microsoft Excel, data was compiled by an outside analyst. A paired student t-test was used, which evaluated measurements of pain, stiffness, and range of motion to determine the statistical significance of improvements.

After receiving injections, patients reported significant reduction in pain and stiffness. The big toe was treated in twelve participants. Though the mean number of treatments was 4.0, the range was 3 – 6 sessions. The average volume of solution injected per visit was 10.0 mL.

Figure 6 Survey responses before and after Prolotherapy on levels of pain with various activities.

Using the Visual Analog Scale (0 = no pain and 10 = crippling/severe pain), patients judged their pre- and post-treatment status on a number of issues: pain levels, stiffness levels, amount of numbness, and need for medications or surgery (Fig. 6). The before and after Prolotherapy VAS scores were compared using a paired student t-test. All p-values for pain were statistically significant at the p <0.0004 level.

Patients’ subjective experience of pain offers the best measure for statistical accuracy. Patients were asked to rate their pain levels on a scale of 0 to 10, with 0 being no pain and 10 being severe crippling pain. All 12 patients reported pain as a symptom. Thus, patients were asked to report pain levels before and after Prolotherapy in these three categories: 1) pain at rest, 2) pain with normal activities, and 3) pain with exercise.

Concerning 1) pain at rest: prior to Prolotherapy treatment, VAS pain levels averaged 4.42. None of the patients had a starting pain of less than two. After Prolotherapy treatment, VAS pain levels averaged 0.083. Only one patient reported a VAS pain level of 1, and all others reported zero.

Concerning 2) pain with normal activities: prior to Prolotherapy treatment, VAS pain levels averaged 6.50. Five of 12 patients could walk less than fifty feet without pain; seven of 12 could not walk a half-mile without pain; and ten of 12 could not walk a full mile. After Prolotherapy, all but one patient reported no restrictions in walking any distance without pain, and a VAS pain level of 1.17.

Concerning 3) pain with exercise: prior to Prolotherapy, five of 12 patients reported being severely compromised (only 0 to 30 minutes possible) in their ability to exercise, and a VAS pain level of 7.42. Of the twelve patients, two were totally compromised and unable to exercise; three were moderately (only 30 to 60 minutes possible). Over half of the patients were severely to totally compromised in their athletic abilities prior to treatment. After Prolotherapy, seven of 12 patients reported being able to exercise as much as they wanted without impediments and with satisfaction, with a VAS pain level of 1.58. Other physical improvements occurred, notably decreases in stiffness (from 4.92 to 2.08) and numbness (from 1.50 to 0.17).

When comparing the three previous categories before and after Prolotherapy, all reached a statistically significant outcome with a paired student t-test of p = <0.0004. This p-value confirms that the numerical results, when compared and tallied, exceed the mathematical probability of mere chance.

Thus, this retrospective study, without a control group, demonstrates that Hackett-Hemwall Dextrose Prolotherapy decreases pain and improves the quality of life for patients with metatarsophalangeal joint pain—unresolved by previous therapies, medications, and interventions. As a result of Prolotherapy, eleven of 12 patients reported a greater than 75% improvement in the activities of daily living that continued to the end of the study. Of the two patients who were told they needed surgery, both felt sufficient pain relief with Prolotherapy to avoid surgery. After the study period, patients experienced overall improvement in range of motion, ability to walk and exercise, as well as relief of stiffness and numbness/burning.

The questionnaire supplied one additional area of data: the use of pain medications. Before Prolotherapy treatment, seven took no pain pills for their condition; five took one to two pills daily. After treatment, one of 12 continued on medication.


Since patients with hallux valgus may require different approaches, a variety of surgical options are offered because one is best suited for each specific type of hallux valgus.[28] Appropriate treatment selection, therefore, is not just a matter of choosing a good option; even a good choice can leave patients with ongoing problems.[28] In this regard, a Cochrane review notes that 25 – 33% of patients were dissatisfied at follow-up.[29] This high failure rate confirms the difficulty of selecting an appropriate treatment for hallux valgus—a difficulty that arises from the complex nature of this degenerative disease. Because Prolotherapy addresses many of the underlying causes of hallux valgus, its effectiveness as a treatment is more likely, making Prolotherapy a more reliable option.

Although Prolotherapy has a long history of treating pain, this study is the first to document its success as a treatment for chronic metatarsophalangeal joint pain. Three double blind studies establish a statistically significant improvement in osteoarthritis with Prolotherapy.[30, 31, 32] Prolotherapy’s apparent success with osteoarthritis and ligament laxity is encouraging, demonstrating its potential as a viable alternative to the traditional treatments of hallux valgus.

The mechanisms by which Prolotherapy decreases pain are multifactorial. Prolotherapy, a known stimulant for the regeneration of tendons and ligaments, also repairs articular cartilage and menisci.[33] In cases of osteoarthritis, Prolotherapy has been shown to return motion to painful joints, and in patients with severe dysfunction, to alleviate the need for joint replacement.[33, 34] As a comprehensive treatment, Prolotherapy is well-suited for metatarsophalangeal joint pain, which is also multifactorial.

The etiology of hallux valgus, for example, includes poor fitting footwear, bony abnormalities in the shape and length of the metatarsal head, foot pronation (flat-footedness), and inflammatory joint diseases.[9, 35] Due to Prolotherapy’s cascade of healing factors that regenerates tissues, the underlying factors that cause both hallux valgus and hallux rigidus can be remedied.

Specifically, the underlying condition of both hallux valgus and hallux rigidus is the instability that causes osteoarthritis of the MTP joint, initiating bone growth to stabilize the joint. (This growth in boney tissue occurs mainly on the medial side of the foot, producing the characteristic bump or bunion.) The instability that predisposes joints to osteoarthritis typically starts when ligaments and tendons supporting the joint become weakened or injured. Because the joint is no longer held in place by healthy ligaments and tendons, unstable joint motion develops and eventually exerts a strong pressure on parts of the cartilage. Then cartilage degenerates, which leads to a crunching and grinding joint. With time, the body reacts to this instability by contracting the muscles in the area. Eventually tense muscles get “knotted up” and finally release when they lose their strength due to fatigue. Because of this muscular failure, bone mass increases in an attempt to stabilize the joint. In a last ditch effort to recover joint stability with bone growth, a completely frozen joint occasionally occurs. Due to instability—pathological bone growth is what produces hallux rigidus. By re-growing cartilage and strengthening ligaments and tendons, Prolotherapy can stop the arthritic cascade, initiating a healing cascade that stabilizes the joint and reverses the degeneration to arthritis.

To enable this reversal and regeneration, Prolotherapy historically has utilized many solutions, but Dextrose has been proven to be a uniquely safe and effective irritant (sclerosant). Sclerosant is derived from the word “sclera,” which refers to the tough, fibrous white part of the eye and, thus, a sclerosant causes a toughening of injected tissues. Dextrose Prolotherapy is presumed to work by virtue of such mechanisms as direct contact, osmotic tissue absorption, and inflammation.

Practitioners of Prolotherapy realize that typical human cells contain 0.1% Dextrose (D-glucose). When injected with a concentrated glucose solution, tissues respond by increasing cellular protein synthesis, DNA synthesis, and cell volume—all components of cellular proliferation.[36, 37, 38, 39, 40] Introduction of extracellular Dextrose increases growth factors near the injection site. These growth factors include platelet-derived growth factor, transforming growth factor-beta (TGF-β), epidermal growth factor, basic fibroblast growth factor, insulin-like growth factor, and connective tissue growth factor, which are especially suited to the repair of tendons, ligaments, and soft-tissues.[41, 42, 43, 44, 45, 46] Furthermore, studies show that Dextrose-based injections stimulate inflammation, fibroblastic proliferation, and repair of articular cartilage defects. [47, 48, 49, 50, 51, 52, 53] Combined with 1 IU, human growth hormone (hGH) may be used to treat the MTP joint for increased cartilage growth. The connection between hGH and cartilage growth is readily apparent in those suffering from acromegaly, a condition whereby the pituitary gland secretes too much hGH that causes the growth of excess cartilage.[33]


As a treatment for MTP joint pain, Prolotherapy provides long-term relief, which may not be the case for other healthcare options. The efficacy of those options is not known, since follow-up in hallux valgus studies is often insufficient or nonexistent. Although many studies have been done on hallux valgus, the Cochrane review shows that the follow-up techniques used in these studies were considered of “dubious relevance” because they failed to accurately assess relief of symptoms.[54] In the material covered by the Cochrane review, only one study asked patients if they were better after surgery than before. In light of these findings, Kilmartin suggests, “future research should include patient-focused outcomes and follow-up periods of at least 5- to 10-years.”[54] This retrospective study on patients suffering from hallux valgus and hallux rigidus concentrated on patient outcomes—assessing pain, stiffness, and range of motion.

As a result of Prolotherapy, eleven of the twelve patients studied reported a greater than 75% improvement in the activities of daily living that continued to the end of the study. While not all of our study patients were contacted five years after treatment, 3 out of 12 patients reported a favorable assessment between 5- to -12 years after their final treatment. Given these preliminary positive results, Hackett-Hemwall Dextrose Prolotherapy’s potential for healing and regenerating tissues and not just for reducing pain makes it a promising, safe treatment option for chronic first metatarsophalangeal joint pain.


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Address correspondence to: Ross Hauser, MD, Caring Medical, 715 Lake St., Suite 600, Oak Park, IL 60301

1Medical Director, Caring Medical & Rehabilitation Services; Editor-in-Chief, Journal of Prolotherapy
2Private Practice, Medical Editor, Ohio University Clinical Assistant Professor, Bowling Green State University Adjunct Assistant Professor

© The Foot and Ankle Online Journal, 2012

The Vilex® Hemi-Implant: A Retrospective Analysis of 30 Patients in the Treatment of Hallux Rigidus

by David M. Davidson, DPM 1 , Kenneth T. Goldstein, DPM 2, James D. Yakel, DPM 3

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

Background: Multiple surgical procedures have been described for the correction of hallux limitus deformity. A review of the Vilex® hemi-implant procedure for the surgical treatment of hallux limitus is presented. Clinical outcome and patient satisfaction in 30 patients is reviewed. In addition, a review of the patho-physiology and clinical evaluation of hallux limitus is also discussed.
Methods: The authors reviewed, retrospectively, 30 random cases of patients who failed conservative treatment and underwent a 1st metatarsophalangeal joint implant/arthroplasty using the Vilex® hemi-implant. This implant appears to limit some of the more common complications of implant arthroplasty including, but not limited to subluxation, pain and recurrence of deformity. Patients were chosen randomly after at least 12 months elapsed after surgery. Each patient was provided a questionnaire that asked why they chose to have the procedure and also if their symptoms were improved or eliminated after the procedure.
Results: The vast majority of patients were satisfied with the surgical results. Most were able to return to normal shoes and were able to return to activities with significantly less pain.
Discussion: This study represents a one-year clinical evaluation of patients who underwent surgery for symptomatic hallux rigidus using the Vilex® hemi implant technique. In this group of individuals, the outcome measures were good. The majority of patients reported they would undergo the procedure again.

Key Words: Hallux rigidus, hemi-implant, first metatarsophalangeal joint mobility, satisfaction.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License.  It permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ©The Foot and Ankle Online Journal (www.faoj.org)

Accepted: August, 2009
Published: October, 2009

ISSN 1941-6806
doi: 10.3827/faoj.2009.0210.0003

In 1887, Davis-Colley [1] termed the phrase hallux limitus. Soon after, Cotterill [2] coined the term hallux rigidus.

Hallux rigidus, or degenerative joint disease of the first metatarsophalangeal joint (1st MPJ), is a deterioration of the joint [3] and subsequent ankylosis. This may cause absence of joint motion, resulting in pain and deformity. Numerous etiologies have been attributed to the degenerative process of hallux rigidus, which include elongated first metatarsal [3,4] first ray hypermobility [5,6] metatarsus primus elevatus [7], osteochondritis dissecans [8], and trauma. [9] Conservative techniques such as orthotics, shoe modifications, and steroid injections can be successful in eliminating some pain. If conservative treatment modalities fail, surgical intervention may be necessary.

Multiple orthopedic and podiatric surgical procedures have been described in the literature to address hallux rigidus including joint preservation techniques [10-14], and joint destructive procedures. [15,16,17] The choice of a procedure should be based on the degree of pain, range of motion, activity level of the patient, and surgeon’s preference. Implant arthroplasty is one of many joint destructive techniques to address hallux rigidus. There are certainly many choices available to the surgeon when considering joint replacement. These include the total, hinged silastic implant with grommets, a hemi-silastic implant, a total, two-piece, cobalt chrome implant as well as many variations of a hemi-cobalt chrome implant.

Generally, FDA implanting protocol calls for “cementing” an implant into the phalanx. In over five years of experience and over 200 surgeries performed with the Vilex® CHI, the authors have not found a need for cementing nor have they encountered a dislocated or a loosening of the CHI implant.

Materials and Methods

The authors reviewed, retrospectively, 30 random cases of patients who failed conservative treatment and underwent a 1st MPJ implant/arthroplasty using the Vilex® hemi-implant. Patients were chosen randomly after at least 12 months elapsed after surgery. Each patient was provided a questionnaire that asked why they chose to have the procedure and also if their symptoms were improved or eliminated after the procedure.

Clinical Findings of Hallux Limitus

The most common finding is the gradual onset of pain and limitation of motion in the 1st MPJ. Clinical examination reveals an enlargement of the 1st MPJ dorsally and/or dorsomedially. Palpation of the joint may elicit pain. Early in the process, there may be muscle spasm of the extensor hallucis longus (EHL) tendon. [18] There is typically very limited range of motion (ROM), which may be painful, with or without crepitus.

Plantar flexion range of motion is usually normal. The hallux may be in a fixed plantarflexed position with the interphalangeal joint (IPJ) in a hyper-extended position with keratoses. Soft tissue swelling may be present. If arthritic changes extend into the sesamoid apparatus, the sesamoids may also be tender.

Radiographic Findings

Radiographic changes include first metatarsal head flattening, non-uniform joint space narrowing, osteophytic changes about the first metatarsal head and base of the proximal phalanx, subchondral cysts, and subchondral sclerosis. Metatarsus primus elevatus may be visualized and the proximal phalanx can be positioned plantar to the head of the 1st metatarsal. Regnauld [19] proposed a classification system from developing ankylosis to end stage joint disease:

Grade I:
Functional limitation of first metatarsophalangeal joint dorsiflexion, hallux equinus/flexus, plantar subluxation of the proximal phalanx on the first metatarsal head, metatarsus primus elevatus, functional dorsiflexion of the first metatarsal with weight bearing, no radiographic degenerative changes, hyperextension of the hallux IPJ, or pronatory architecture.

Grade II:
Flattening of the first metatarsal head, osteochondral defect of first metatarsal head, cartilage fibrillation and erosion, pain on end ROM, passive ROM may be limited, mild dorsal prominence, subchondral eburnation, peri-articular lipping of the proximal phalanx, first metatarsal head, and sesamoids.

Grade III:
Severe flattening of first metatarsal head, osteophyte formation, especially dorsally; asymmetric narrowing of joint space, articular degeneration, erosions, crepitus, subchondral cyst formation, pain on full ROM, associated inflammatory flares.

Grade IV:
Obliteration of the joint space, exuberant osteophytosis with loose bodies, less than 10 degrees of ROM, deformity and/or mal-alignment; possible anklylosis and inflammatory flares, local pain as a result of skin irritation or bursitis secondary to underlying osteophytes.Coughlin and Shurnas [20] described a more complete classification system using the amount of dorsiflexion, radiographic changes, and clinical findings:

Grade 0:
Forty to 60 degrees of dorsiflexion and/or 10-20% loss compared to the normal side. No radiographic changes; no pain with only stiffness and loss of motion.

Grade I:
Thirty to 40 degrees of dorsiflexion and/or 20-50% loss compared to the normal side; dorsal osteophyte formation is the main finding with minimal joint space narrowing, peri-articular sclerosis, and minimal plantarflexion.

Grade 2:
Ten to 30 degrees of dorsiflexion and/or 50-75% loss compared to the normal side; diffuse osteophyte formation radiographically, with some flattening of the metatarsal head; with more narrowing and more than ¼ of the dorsal joint space involved and with the sesamoids typically not involved. Clinically, moderate to severe pain and stiffness, and pain occurs just prior to maximum dorsiflexion and plantarflexion.

Grade 3:
Less than 10 degrees of dorsiflexion and/or 75-100% loss compared with the normal side, notable loss of metatarso-phalangeal plantarflexion; radiographic changes are the same as Grade 2 with more narrowing and more than ¼ of the dorsal joint space involved. The sesamoids are either enlarged, cystic, irregular or a combination of all three. Clinically, the pain is more constant and there is significant stiffness at the extremes of range of motion.

Grade 4:
This is the same as Grade 3, from a dorsiflexion and radiographic standpoint. Clinically, there is definite pain at mid-range during passive motion.

Surgical Procedure

A curvo-linear incision is placed on the dorso-medial aspect of the 1st MPJ. Through the same incision, a linear, longitudinal capsulotomy is performed. The capsule is dissected from the head of the metatarsal and base of the proximal phalanx allowing adequate visualization of the MTP. The medial eminence, along with any hypertrophic bone growth and osteophytes, are resected. The base of the proximal phalanx is carefully freed of soft tissue attachments in order to protect the insertion of all intrinsic musculature. Approximately 4-5 mm of bone is then resected from the base, with an osteotomy performed perpendicular to the longitudinal axis of the shaft. The amount of bone removed is twice the thickness of the Vilex® implant to allow adequate decompression of the MPJ joint.

After placing an appropriate sizer over the new end of the proximal phalanx, a guide wire is inserted in the center hole and driven into the bone, making sure the wire is parallel to the long axis of the phalanx and centered therein. The desired implant size is determined by sliding a cannulated sizer over the guide wire. The sizer should sit flush with the resected surface, on the perimeter and not within it. The sizer is removed and the appropriate implant is screwed into the proximal phalanx and the guide wire is removed. (Fig. 1) The implant should be examined in order to ensure that it is flush with the bone. (Fig. 2)

The Vilex® hemi implant procedure allows the surgeon to assess the eventual position the implant before inserting the implant itself. In addition, the implant is screwed into the phalanx without drilling or broaching.

Figure 1  Implant inserted into proximal phalanx over K-wire.

Figure 2  Implant correctly positioned into proximal phalanx.

After a flush with a combination antibiotic/saline solution, the capsule is approximated with 3-0 Monocryl; the subcutaneous tissue is approximated with 4-0 Monocryl and the skin is closed to surgeon’s preference. The surgical site is dressed with sterile compressive dressings.

Postoperatively, the patient is allowed to weight-bear immediately, in a typical, postoperative shoe. Sutures are removed in 10-14 days and most patients are referred to physical therapy for early, range of motion exercises. We have found that when patients ambulate to tolerance and motion exercises are instituted early in the postoperative period, patients respond more favorably.


The patients ranged in age between 40 – 78 years of age and all patients in this study were classified, based on their clinical history, having no major, systemic, medical problems (Table 1) Pre-operatively, 60% were performing moderate to significant exercise programs, 88% related moderate to severe pain that limited their activities, 80% were restricted in the types of shoes they could wear and only 39% did not like the way their foot looked. (Table 2)

Table 1  Hallux rigidus implant pre-operative evaluation.

Table 2  Implant results before and after surgery for patient group.

Post-operatively, 80% related no or slight discomfort, 92% could participate in almost all activities without problems, 100% stated they could wear orthopedic, casual and/or any type of shoe, the majority of the time, only 22% did not like how their foot looked post-operatively, 80% felt they had more motion than pre-operatively and 77% of the patients were pleased with the outcome of the procedure. (Table 3) Of those not pleased, some were still having joint discomfort and some thought it took longer than they expected to recover.

Table 3  Hallux rigidus implant postoperative evaluation.


This study represents a one year, clinical evaluation of patients who underwent surgery for symptomatic hallux rigidus using the Vilex® hemi implant technique. In this group of individuals, the outcome measures were good. The majority of patients reported they would undergo the procedure again.

There should be no question that with all patients who present with symptoms due to hallux limitus or hallux rigidus, all methods of conservative care should be exhausted before entertaining thoughts of surgical intervention. A joint destructive technique of any kind should never be presented to the patient as “restoration of the original” or “as good as new”.

The goal should be limited to pain reduction and joint flexibility as opposed to arthrodesis. Steroid injection, anti-inflammatories, physical therapy and/or biomechanical (functional or accommodative) therapy are all possible choices of care. Once it is determined that a joint destructive technique would be beneficial, we have found that the Vilex® hemi-implant is a very useful procedure. The Vilex® Cannulated Hemi Implant (CHI) offers numerous advantages, some but not all are shared by others:

Material – With Vilex®, the surgeon has the option to use either titanium or cobalt-chrome with titanium backing. The titanium is lighter in weight than cobalt-
chrome implants. In addition, titanium does not contain nickel, thereby avoiding the potential of allergic reaction to nickel present in cobalt-chrome. Also, the titanium is less likely to distort magnetic resonance imaging (MRI) should the patient need MRI scanning in the future.

Low Profile – The articular surface is elliptical in shape and its thickness ranges from 1.5 to 2.0 mm. In resecting the base of the proximal phalanx, the surgeon needs to remove between 3-4 mm of bone to provide room for the implant and to decompress the 1st MPJ. This is a major advantage to the patient because the minimal resection preserves the intrinsic structure of the joint and preserves the toe both functionally and cosmetically. In addition, it retains the option for the surgeon to perform arthrodesis or a Keller arthroplasty should the implant fail.

Cannulation – The fact that the implant is cannulated enables the implant to be placed optimally. After inserting a 1.6 mm guide wire, the surgeon can assess the position, orientation of the implant, and the accuracy of the cut. The surgeon can correct any error by simply relocating the guide wire. Once the wire is placed, the surgeon can visualize the final position of the implant through a simple test.

Screw Shaft – The implant shaft is essentially a cannulated screw with tight thread pitch and very generous major to minor diameter ratio. The three screw tips are hand-sharpened so that implanting the implant does not require drilling or tapping. The CHI is the only hemi-implant on the market with this type of shaft.

The majority of patients in this study did have significant improvement in symptoms. We have noted excellent results with substantial reduction in pain and an increase in the range of motion of the 1st MPJ.


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Address correspondence to: David M. Davidson, DPM
Email: ddavidsonaapsm.org
3980 Sheridan Drive, Amherst, NY 14226
Phone (716) 839-3930, Fax: (716) 839-2667

1 3980 Sheridan Drive, Amherst, NY 14226
2 3980 Sheridan Drive, Amherst, NY 14226
Phone: (716) 839-3930, Fax: (716) 839-2667
3 36 S. 18th Ave., Ste. H, Brighton, CO 80601
Phone: (303) 659-5950, Fax: (303) 654-0948

Interest Disclosure: The authors have no financial relationship or conflicts of interest with Vilex®, Inc. other than occasional speaking engagements.

© The Foot and Ankle Online Journal, 2009