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Hardware Related Pain and Hardware Removal after Open Reduction and Internal Fixation of Ankle Fractures

by Johan H. Pot1  , Remco J.A. van Wensen1, Jan G. Olsman1

The Foot and Ankle Online Journal 4 (5): 1

Objectives: To assess the incidence of hardware related pain after open reduction and internal fixation (ORIF) after ankle fractures through functional outcomes scores in patients with or without hardware related pain. Design: Retrospective study.
Setting: Regional trauma center.
Patients: One hundred and seventy six patients undergoing ORIF of an ankle fracture with a minimal follow up of 18 months were sent questionnaires. In total, 80 responding patients were available for analysis.
Main Outcome Measurements: Visual Analog Pain Score, Foot and Ankle Outcome Score (FAOS).
Results: In seventeen patients (21%), the hardware was removed because of pain. In another seventeen patients (21%), the hardware was not removed, but pain was reported. Patients with hardware related pain had significantly worse functional outcome scores than patients without hardware related pain. After elective hardware removal, pain reduction was achieved in 71 % of the patients. Mean Visual Analog Score was 7.0 before and 3.9 after elective hardware removal for pain.
Conclusions: Hardware related pain is a significant issue after ORIF of ankle fractures. Patients with hardware related pain have significantly worse functional outcome scores. Although pain reduction is achieved in 71% of the patients after elective hardware removal, a substantial number of patients have persistent complaints. Patients should be well informed about the expectations and risks of elective hardware removal.

Key words: Hardware, hardware removal, hardware related pain, ankle fracture, ORIF ankle, FAOS.

Accepted: April 2011
Published: May 2011

ISSN 1941-6806
doi: 10.3827/faoj.2011.0405.0001


Fractures of the distal tibia and fibula are one of the most common types of fractures in adults. [1] Whereas stable and non or minimally displaced fractures can be treated with cast immobilization, unstable dislocated ankle fractures require open reduction and internal fixation (ORIF) with plate and screws.

Long term functional outcome is satisfying in most patients, but a number of patients have persistent ‘hardware related’ complaints and tenderness that ‘require’ elective hardware removal. Aside from painful hardware, some asymptomatic patients also want their hardware removed for other reasons. Although hardware removal is frequently undertaken, it is not without risk and the results are often unpredictable. [2]

The more commonly reported risks of hardware removal are iatrogenic (nerve) injury, infections, delay in wound healing and re-fractures. In addition to medical considerations there is also an economic impact such as physician costs, hospital fees, patient loss of work and productivity. [2] Reports in literature are not consistent concerning the incidence of painful hardware and the outcome and pain relief after hardware removal. [3-5] This study was designed to document the incidence of late pain after ORIF of ankle fractures and to analyse the outcome, expectations and complications after hardware removal.

Patients and Methods

In October 2010, all patients with surgically treated unstable ankle (malleolar) fractures between April 2007 and April 2009 were reviewed. A total number of 176 patients were included with a minimum follow up of 18 months assuming the end stage of rehabilitation after the ankle fracture was achieved. Demographic data, patient’s age, sex and medical history, were obtained from the hospital database and clinical notes. All patients were sent a questionnaire. One part consisted of the Foot and Ankle Outcome Score (FAOS) which is designed to asses a number of foot and ankle related problems. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport) and foot and ankle-related Quality of Life (QOL). The second part of the questionnaire consisted of specific questions about pain at the site of the hardware material and specific questions about the removal of osteosynthesis material. Patients that underwent elective hardware removal were asked to indicate pain before and after hardware removal by a Visual Analog Scale (VAS) pain score. Surgical stabilization consisted of open reduction and internal fixation (ORIF).

All surgeries were performed in the Jeroen Bosch Hospital, a 600 bed teaching hospital, by or under direct supervision of one of the trauma surgeons. AO-fixation material was used including small-fragment plates and screws and sometimes K-wires on the fibula or tibia if necessary. Fixation of the posterior malleolus was performed if more than one-third of the joint surface on the lateral radiograph was affected. Syndesmotic fixation was performed in cases of widened mortises on stress-testing after ORIF. Most of the time, one hook test was performed.

Postoperative therapy was overall direct functional and non-weight bearing for a minimum of six weeks. Sometimes a below-the-knee plaster cast was applied for 1 week due to wound protection. After 6 weeks, patients were allowed to bear weight as tolerated and were referred for outpatient physical therapy if necessary. Patients that were treated with a syndesmotic screw remained non-weight bearing until the syndesmotic screw had been removed. According to one of the trauma-surgeons, weight bearing was allowed after 6 weeks without removal of the syndesmotic screw. Indications for hardware removal include infection, failure of osteosynthesis material, severe pain and tenderness on the location of hardware and specific demands in asymptomatic patients. Before the procedure was performed, fracture consolidation was assessed by a radiograph. Functional outcome scores for each FAOS subscale were correlated with the presence of local pain. Statistical analysis was performed by using the Student t test. Results were considered significant if p

Results

The questionnaire was sent to 176 patients. The response rate was 46% (n=80 patients). In the response group there were 24% males and the mean age was 44 ±23 years. The mean follow up was 30 months and 29 patients (36%) reported hardware removal. (Table 1) The indication for removal was pain or discomfort in 60% (n=17).

Table 1 Patients with hardware removed and painful or painless hardware.

In one patient it was removed because of infection and syndesmotic screws were removed in 37% (n=11) as a standard procedure before weight bearing was allowed. In patients that did not have osteosynthesis material removed (n=51), 33 % had local pain or tenderness on the location of the osteosynthesis material. In total, 34 patients had pain at the hardware site after ORIF (42%). (Table 1)

FAOS score were compared between patients having local pain or tenderness overlying the hardware, patients who did not and patients that underwent hardware removal because of pain. Lower scores indicate a lower functional level and these scores are shown in Figure 1.  The FAOS scores of patients without hardware related pain was significantly higher in all the 5 subscores. (P<0.05) compared to patients with hardware related pain. Patients that underwent elective hardware removal however did not have significantly different scores than those with painful hardware.

Figure 1 FAOS scores of all patients with surgically treated ankle fractures. Patients without painful hardware have significantly higher FAOS score in all subscores compared to patients with hardware related pain (removed or not).

In 71% of the patients that underwent elective hardware removal because of pain, reported a decrease of their complaints after hardware removal.

These patients had a mean pain VAS (visual analog scale) of 7.0 (±2.1) before hardware removal and a mean VAS of 3.9 ±2.8 after hardware removal. This was a significant pain reduction. (p=<0.05)  However in 27% of the patients VAS scores did not change after elective hardware removal and only 24% became pain-free with a VAS of 0. (Table 2)

Table2   Change in pain after elective hardware removal (for painful hardware).

Recovery time from the secondary surgery was approximately 9 weeks (±10). Range of motion improved in 56% of the patients, whereas 6 % reported a decreased range of motion after hardware removal. 39% of the patients did not notice any change in range of motion. In 20% of the patients a superficial wound infection was reported that required additional treatment. No re-fractures or pseudoarthrosis were reported. Furthermore 25 % of the patients reported new complaints after hardware removal, such as other pain or instability.

Discussion

After a mean follow up of 2.5 years 21% of the patients reported to have their hardware removed because of pain and 21% of the patients had significant and specific local pain at the site of the hardware. Obviously, hardware is not always the main contributor of this pain as scar tissue, post-traumatic changes and malalignment can also play a role. This should not be underestimated by (orthopedic) trauma surgeons. One study found similar results with 31% painful hardware and 17% removal. [4] However other studies report lower rates of painful hardware [6,7], especially among the elderly.8 Patients with painful hardware and also patients who had their hardware removed have significantly lower functional scores than patients without complaints.

In fact, all FAOS subscores were significantly worse in these patients suggesting a serious impact on quality of life and on daily activities. This is supported by Brown, et al., [4] who found significantly better outcome scores in patients that did not have hardware related pain. The results of hardware removal are comparable to Jacobsen, et al., [3] who found a 75% improvement after hardware removal. Brown on the other hand found a pain reduction in only 50% of the patients. A success rate of 71% in this study appears to be a promising statistic. However, in 76% of patients, they do not become pain free and have persistent pain. Patients should be informed correctly about the significant risk of persistent pain.

Range of motion is similar or better in most patients, but 25% of the patient had new or other complaints after removal of the hardware. Other studies that do not specifically investigate hardware removal of the ankle but hardware removal in general find other results. A prospective review about outcome of different types of hardware in different body parts found a significant pain relief, improved function and improved SMFA scores (Short Musculoskeletal Function Assessment Questionnaire). [5] Hardware in ankles, however can lead to location specific problems due to mechanical characteristics of the ankle and the lack of surrounding tissue in the ankle. Indications for elective hardware removal could be a pitfall. Local tenderness and pain can be due to the hardware, but can also be caused by posttraumatic changes in the ankle. Hence the surgeon and patient should also be well informed about specific complaints and a radiograph is mandatory to evaluate posttraumatic changes. If in doubt, an intra-articular injection with a local anaesthetic can help to differentiate between intra articular (post traumatic) and extra-articular (e.g. hardware) causes. Arthroscopic evaluation can be useful to assess degenerative changes, intra-articular malalignments or to remove loose bodies or adhesions.

Routine removal of hardware in patients with surgically treated ankle fractures is not recommended, because most patients do not have hardware related pain or may have minimal symptoms. Not only would routine hardware removal lead to more complications, increased health care costs, lost work and productivity, it can also lead to new complaints or increased pain. [2]

The type of implant or material may influence the amount of hardware related symptoms. Obviously bulky implants are more likely to cause symptoms, but smaller implants can lead to bony overgrowth which makes hard removal more difficult. Intramedullary nailing may be beneficial in some fractures, because soft tissue is less manipulated and also these implants can be easier to remove. [9]

Biodegradable osteosynthetic material have been proposed as a new method to avoid a secondary procedure to remove the material. [10] Although materials are improving, clinical results thus far are not encouraging. Petrisor, et al., concluded that patients with biodegradable osteosynthesis material had a higher risk (OR 2.63) for adverse events, such as osteosynthesis failure, compared to metal implants in patients with ankle fractures. [11] Ahl, et al., [10] found that patients treated with traditional titanium implants had better radiological measured stability, although clinical results did not differ. It is not clear whether these biodegradable materials result in less tenderness on palpation in short and long term.

Conclusion

Hardware related pain is a big issue in patients with a surgically treated ankle fracture that must not be underestimated. Functional outcome scores are significantly worse in patients with hardware related pain. Pain reduction can be achieved in 71% of the patients with hardware related pain but only 24% of the patients became pain-free after hardware removal. Similar results were found in literature. The most important conclusion that can be drawn is that the patient should be informed correctly about the risks and expectations of this second operation.

References

1.Daly PJ, Fitzgerald RH, Jr Melton LJ, Ilstrup DM. Epidemiology of ankle fractures in Rochester, Minnesota. Acta Orthop Scand 58: 539-544, 1987.
2.Busam ML,Esther RJand Obremskey WT. Hardware removal: indications and expectations. J Am Acad Orthop Surg 14: 113-120, 2006.
3.Jacobsen S,Honnens de Lichtenberg M,Jensen CM, Torholm C. Removal of internal fixation–the effect on patients’ complaints: a study of 66 cases of removal of internal fixation after malleolar fractures. Foot Ankle Int 15: 170-171, 1994.
4.Brown OL, Dirschl D, Rand Obremskey WT. Incidence of hardware-related pain and its effect on functional outcomes after open reduction and internal fixation of ankle fractures. J Orthop Trauma 15: 271-274, 2001.
5.Minkowitz RB,Bhadsavle S,Walsh M, Egol KA. Removal of painful orthopaedic implants after fracture union. JBJS 89A: 1906-1912, 2007.
6.Bostman O and Pihlajamaki H, Routine implant removal after fracture surgery: a potentially reducible consumer of hospital resources in trauma units. J Trauma 41: 846-849, 1996.
7.Michelson JD. Fractures about the ankle. JBJS 77A: 142-152, 1995.
8.Koval KJ,Zhou W,Sparks MJ, Cantu RV, Hecht P, Lurie J. Complications after ankle fracture in elderly patients. Foot Ankle Int 28: 1249-1255, 2007.
9.Guo JJ,Tang N,Yang HL, Tang TS. A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia. JBJS 92B: 984-988, 2010.
10. Ahl T, Dalen N, Lundberg A, Wykman A. Biodegradable fixation of ankle fractures. A roentgen stereophotogrammetric study of 32 cases. Acta Orthop Scand 65: 166-170, 1994.
11.Petrisor BA, Poolman R, Koval K, Tornetta P 3rd, Bhandari M; Evidence-Based Orthopaedic Trauma Working Group. Management of displaced ankle fractures. J Orthop Trauma 20: 515-518, 2006.


Address correspondence to: Johan Pot, Jeroen Bosch Hospital, Location Groot Ziekengasthuis, Postbus 90153, 5200 ME ’s-Hertogenbosch, The Netherlands. Email: johanhpot@gmail.com

1  Jeroen Bosch Hospital, ’s-Hertogenbosch, the Netherlands. Department of Surgery, Postbus 90153, 5200 ME ’s-Hertogenbosch The Netherlands. tel: (+31) 73-6992000; fax:(+31) 73-6992163.

© The Foot and Ankle Online Journal, 2011

Measurement Reliability of Swelling in the Acute Ankle Sprain

by Cameron P. Watson, MAppSc1,4, Robert A. Boland, PhD1,3 , Kathryn M. Refshauge, PhD2

The Foot & Ankle Journal 1 (12): 4

Background: Swelling and painful restriction of dorsiflexion characterize acute ankle sprain, and require accurate measurement to monitor effectiveness of intervention. Reliability of the figure of eight tape method for swelling and the weight-bearing lunge for dorsiflexion are highly reliable in the laboratory, but untested in the less predictable clinical setting.
Materials and Methods: We determined intra and interrater reliability and standard error of measurement (SEM) of both methods in the clinical environment, using 4 physiotherapists as raters. Measurements were taken twice within a session and at a follow-up session from the uninjured ankle in 22 participants with unilateral ankle sprain, and from a randomly selected ankle in 11 uninjured participants.
Results: Within session intrarater reliability was very high for both figure of eight (Intraclass correlations coefficients [ICC] = 0.99) and weight-bearing lunge (ICC = 0.97) methods. Between-session inter-rater reliability was also very high (ICC > 0.99). The SEM was small for all measurements: ±0.2cm for figure of eight, and ±0.4cm for dorsiflexion lunge methods within a session, and ±0.3cm and ±0.4cm respectively for between-session measurements.
Conclusions: Using simple techniques, swelling and dorsiflexion can be measured with high reliability in the clinic by different clinicians and can detect small changes in status between and within treatments.
Clinical Relevance: Clinically meaningful changes (>0.5cm) can be detected by clinicians with varying levels of expertise and can confidently be attributed to the intervention rather than measurement error.

Key words: Swelling, ankle, inversion, sprain, standard error of measurement

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 & Ankle Journal (www.faoj.org)

Accepted: November, 2008
Published: December, 2008

ISSN 1941-6806
doi: 10.3827/faoj.2008.0112.0004

Ankle sprain is one of the most common injuries amongst sporting populations [9], and possibly in the general community. In addition to pain, the earliest symptoms are swelling and restricted dorsiflexion range of motion, and these symptoms can persist for years in up to 70% of people after a sprain. [14] To determine efficacy of treatment and monitor progress, it is essential that these impairments be measured reliably and accurately in the clinic.

Swelling secondary to sprain of the lateral ankle ligaments is commonly localized, usually around the lateral malleolus [18,19], but can also accumulate around the subtalar, talocrural and inferior tibiofibular joints.

Measurement of swelling therefore needs to specifically include measurement of volume in these areas. The gold standard for such measurement is the water displacement method [13, 16], but this method may be too time-consuming to use efficiently in the clinic. Although an indirect method of measuring ankle swelling, the figure of eight method [13] is time-efficient, cost-effective, and easy to apply in clinical settings. The therapist wraps a tape measure over standardized anatomical landmarks around the ankle and the distance provides a circumferential estimate of volume. [13, p. 131] (Fig. 1)

Figure 1 The figure of eight tape method for measuring ankle swelling.

The figure of eight method is highly reliable for measuring ankle swelling in the laboratory: within-session intra and interrater reliability ranged from 0.98 to 0.99 (intraclass correlation coefficients [ICC] for asymptomatic and swollen ankles. [13,16,21] Furthermore, the method correlates highly (r>0.88) with the water displacement method for both injured [13,16] and uninjured [11] ankles, thereby conferring some validity for the figure of eight method.

Ankle dorsiflexion range of motion (ROM) during weight bearing is also commonly limited following ankle sprain [10,17] , with consequent high impact on functional activities such as walking [2,3,5,8] , and ascending and descending stairs. [1,12] Restoration of ankle dorsiflexion ROM is therefore a priority of early rehabilitation. [2,3,8]

Measurement of dorsiflexion in standing4 simulates the ROM achieved during these functional tasks. [1,6] This is particularly relevant because the torques applied to the ankle in weight-bearing are clearly greater than in non-weight-bearing, and the resultant measurement may be more indicative of the range available for functional activities. [4,5]

Measurement of ankle dorsiflexion ROM using the weight bearing lunge method has been shown [4] to be highly reliable in the laboratory (between-session intra-rater reliability ICC(3,3) 0.97 to 0.98, within-session inter-rater reliability ICC(2,3) 0.99. However, it is unclear whether these methods are efficient and reliable in uncontrolled clinical environments, where high reliability is essential for monitoring of progress and treatment effects.

The aim of the current study therefore, was to assess in the clinical environment the reliability of: i) the figure of eight method; and ii) the weight bearing lunge method for measurements taken within- and between-sessions. The unaffected ankle of participants was investigated because it is not possible to determine between-session reliability on the injured ankle, given the expected rapid changes in swelling and dorsiflexion range [10] and associated confounding effects of intervention on repeatability. Nevertheless, this information is important clinically, because, similar to Phase I and II trials, laboratory results cannot necessarily be generalized to the clinical environment.

Methods

Design

A repeated measures design was used to test reliability. When a participant was attending for treatment of an injured ankle, the treating therapist and a second rater measured outcomes on the uninjured ankle before treatment commenced for the affected ankle.

On the first test occasion, raters took two measurements of both ROM and swelling within a 1-hour period. Repeat measurements for between-session reliability were taken approximately one week later. To minimize unblinding, raters used a new data sheet to record each measurement before sealing each data sheet in an opaque envelope for later analysis.

Participants

The raters were four physiotherapists of varying post-graduate experience (range 4 -15 years, mean 8.2 years). The participants (patient group) consisted of 15 males and 18 females aged 10 to 76 years (mean, standard deviation [SD]: 28, 14.3 years), recruited from staff and patients attending a physiotherapy and sports injury clinic in Sydney, Australia. Eleven participants (3 male, 8 female) were injury-free and asymptomatic. Twenty-two (12 male, 10 female) had sustained a recent unilateral ankle sprain, fifteen while participating in competitive sport, and seven while walking on an uneven surface. The asymptomatic contralateral ankle was measured in injured participants and a randomly selected ankle in healthy participants. While raters routinely used the figure of eight and dorsiflexion lunge methods in their clinical practice, they were familiarized with the standardized protocols for measurement before undertaking data collection.

Protocols

i) Figure of eight method for measuring swelling

The protocol used in the current study was based on that described by Mawdsley. [13] Participants were positioned in long-sitting on a bed with the experimental foot resting over the end. (Fig. 1) The following standardized landmarks were marked with a pen prior to measurement: a) the point midway over the anterior ankle between the tibialis anterior tendon and lateral malleolus, b) the navicular tuberosity, c) the base of the fifth metatarsal, and d) the inferior tip of the medial malleolus.

To blind therapists during measurements, one surface of a double-sided retractable plastic tape measure was blackened leaving the zero point visible. The rater placed the zero point over the mark on the anterior aspect of the ankle and pulled the tape medially over the navicular tuberosity, and then infero-laterally across the medial arch to the proximal aspect of the base of the fifth metatarsal. The tape was then pulled superiorly and medially over the tarsal bones across the inferior aspect of the medial malleolus, and postero-laterally around the Achilles tendon over the distal lateral malleolus to finish at the zero point. The rater tightened the tape measure and then released tension slightly to ensure there was no indentation of soft tissue. To obtain the measurement, a clip was placed at the point of intersection between the zero and finish points of the tape. (Fig. 1) The examiner removed and turned over the tape and recorded the result to the nearest millimeter.

ii) Weight-Bearing lunge for range of ankle dorsiflexion

The weight-bearing lunge used to measure ankle dorsiflexion range was based on that described by Bennell, et al., [4]. Each participant stood on an apparatus consisting of a horizontal footplate attached to a vertical board . (Fig. 2)

Figure 2  The weight-bearing lunge method for measuring ankle dorsiflexion.

Participants aligned the great toe and heel of the test leg over a line marked along the center of the footplate. Participants were instructed not to lift the test heel, checked by the examiner who gently palpated for lifting [4] while the participant moved the knee forward into a lunge position, until the patella touched the midline of the vertical board. To prevent forward movement of the great toe as the knee moved forward over the foot, a block was placed in front of the great toe. The measurement recorded was the distance (cm) from the vertical board to the great toe. Participants were given up to five attempts and the best performance was used for further analysis.

Data Analysis

SPSS for Windows™ was used to calculate ICCs (ICC(1,1) and ICC(2,1)) and 95% confidence intervals (CI)20 for each method, within- and between-raters and within- and between-sessions. The ICC values were interpreted according to the definition of Munro and Page [15]: ICC values 0.00 to 0.25 indicated little, if any correlation; 0.26 to 0.49 low correlation; 0.50 to 0.69 moderate correlation; 0.7 and 0.89 high correlation, and 0.9 to 1.0 indicated very high correlation.

The SEM [15], was calculated for repeated measurements on the same participant, within- and between-sessions, and was expressed in the original units of measurement to provide error data in clinically relevant terms. Paired t-tests were used to compare the means for each measurement occasion.

Results

Intra-rater reliability: within session

Measurements of swelling using the figure of eight method and ankle dorsiflexion using the weight-bearing lunge were taken by the same rater one hour apart. For the figure of eight method, ICC(2,1) values were > 0.90 (Table 1), consistent with very high correlation. [15]

Table 1  Intraclass correlation coefficient (ICC(1,1)) (ICC(2,1)) with 95% Confidence Interval (CI) for intra- and inter-rater reliability of figure of eight and weight bearing lunge measurements respectively.  Data are shown for within and between sessions (n = 4 raters).

There was no difference in mean swelling between the first and second measurements (p = 0.32). The SEM was 0.2cm (Table 2) indicating that a therapist taking a repeat measurement of swelling after treatment could be confident on 95% of occasions that any reduction >0.4cm (1.96 x SEM) would be due to the treatment. Alternatively, an increase of ≥0.4cm would indicate that swelling had increased.

For the dorsiflexion lunge method of measuring range of motion, ICC(1,1) values were also >0.90 (Table 1), consistent with very high correlation. There was no difference in mean dorsiflexion range between the first and second measurements (p=0.5). The SEM was 0.4cm (Table 2). Thus, a therapist taking a repeat measurement after treatment using the weight-bearing lunge could be confident on 95% of occasions that any change in range of motion of >0.8cm could be attributed to treatment.

Table 2  Means (standard deviation) for the 2 measurement occasions and standard error of the measurement (SEM) for figure of eight swelling and weight bearing lunge dorsiflexion lunge measurements (n = 4 raters).

Intra-rater reliability: between session

Measurements of ankle swelling and ankle dorsiflexion were repeated, on average, 6.8 days (range 2 – 28 days) after the first measurement occasion. For the figure of eight method, ICC(2,1) values were > 0.90, consistent with very high correlation (Table 1). There was no difference in mean swelling between measurement occasions (p = 0.29). The SEM was 0.3cm (Table 2), indicating that a therapist taking measurements between treatment sessions could be confident on 95% of occasions that a difference in swelling of > 0.7cm between treatments would not be due to error.

For the dorsiflexion lunge method of measuring range of motion, ICC(1,1) values were > 0.90, consistent with very high correlation (Table 1). There was no difference in mean dorsiflexion range of motion between sessions (p = 0.2). The SEM was 0.4cm (Table 2) indicating that a therapist taking repeat measurements between occasions could be confident on 95% of occasions that a difference in ROM of > 0.8cm would not be due to error.

Inter-rater reliability: between sessions

To determine inter-rater reliability, two different raters made the repeat measurements of swelling and range of motion, on average 6.8 days (range 2 – 28 days) apart. For the figure of eight method, ICC(1,1) values were > 0.90, indicating very high reliability (Table 1). There was no difference in mean swelling (p = 0.2) between the two measurement occasions. The SEM was 0.3cm (Table 2), indicating that a different therapist repeating the measurement one week later could be confident on 95% of occasions that a change in swelling of > 0.6cm would not be due to error.

Similarly, for the dorsiflexion lunge method of measuring range of motion, ICC(1,1) values for inter-rater reliability were > 0.90, consistent with very high correlation (Table 1). There was no difference in mean range of motion for dorsiflexion (p = 0.09). The SEM was 0.4cm (Table 2), indicating that a therapist taking a repeat measurement one week after the first occasion could be confident on 95% of occasions that any difference in ROM of >0.8cm after treatment would not be due to error.

Discussion

The current results indicate that intra- and inter-rater reliability were very high for measurements taken in the clinic for both the figure of eight method (ankle swelling) and the weight-bearing lunge method (ankle dorsiflexion). Whilst previous research has reported acceptable reliability in a well-controlled laboratory environment, the current study demonstrated reliability of these methods in the variable clinical environment. Very high intra and interrater reliability was observed for measurements repeated within a single session, and after a one-week interval. Therefore, clinicians can use both techniques with confidence within and between sessions to determine the effects of interventions to improve ankle swelling and dorsiflexion range following ankle sprain. The results presented here will assist clinicians with decisions regarding the management of ankle sprain and monitoring progress with treatment.

Despite the inherent differences between the demands of the clinical environment and the laboratory environment, such as time constraints during measurement procedures and a more unpredictable environment [7], the current findings for the figure of eight tape method are comparable to data derived from laboratory studies. Very high intra- and inter-rater reliability (ICC values 0.98 – 0.99) have been reported using the figure of eight method for injured [13,16] as well as asymptomatic [11, 21] ankles. However, previous research has only documented the reliability of the figure of eight method for repeated measurements taken within a single session. [11,13,16] The current study observed very high intra and interrater reliability both within and between-sessions, with a comparable SEM of 0.4 to 0.5cm [11,13], and therefore has demonstrated that different therapists can treat the same patient on different occasions and use the figure of eight method to confidently determine treatment effects. Furthermore, the small SEM observed in the current study informs clinicians that changes in swelling of greater than 0.7cm are more likely due to intervention effects than error. This suggests that the error is considerably less than changes that would be considered clinically worthwhile.

The figure of eight method has been reported to correlate well with water displacement methods for measurements of ankle swelling after lower limb injury. [13,16] While water displacement is the gold standard method for measuring lower limb volume [11,13,16], the method is time consuming, requiring between 5 and 6 minutes to perform, whereas the figure of eight method requires approximately 30 seconds to perform. [11] It also requires relatively sophisticated equipment, unlike the tape measure method. Therefore, the figure of eight method may not only be a more time-efficient method for measuring ankle swelling, but also can be used without sacrificing reliability; even between raters, and between sessions.

Similarly, very high15 intrarater reliability results have been reported for the weight bearing lunge method of measuring dorsiflexion in participants with asymptomatic ankles, within and between sessions, and for different raters taking repeat measurements within a single session.4 The current data recorded in a clinical environment are comparable to previous data collected in a laboratory environment, and again indicate that use of a cost and time-efficient method does not sacrifice reliability. Clinicians can therefore be confident that the weight-bearing lunge method for measuring dorsiflexion range is robust in the clinical environment. Furthermore, the small SEM suggests that clinicians detecting changes in ROM of greater than 1cm are more likely to be observing intervention effects than error.

Conclusions

Whereas previous studies using the figure of eight method for measuring ankle swelling and weight bearing lunge for measuring dorsiflexion have been conducted in laboratory settings, the current study was conducted in a clinical setting characterized by more variable environmental conditions and constraints that replicated conditions likely to be encountered by clinicians during rehabilitation of ankle sprain. In the current study, intra and interrater reliability for each method was observed to remain very high for both within and between sessions data. Therefore, with adequate familiarization, these simple, reliable, and time efficient methods can be used with confidence by clinicians with varying levels of expertise to assess treatment effects on swelling and ankle dorsiflexion in clinical populations.

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Address correspondence to: Robert A. Boland, PhD
University of Sydney, Faculty of Health Sciences, Discipline of Physiotherapy. PO Box 170, Lidcombe, NSW 1825, Australia.
Email: R.Boland@usyd.edu.au

1 University of Sydney, Faculty of Health Sciences, Discipline of Physiotherapy. East St., Lidcombe, NSW, Australia.
2 University of Sydney, Faculty of Health Sciences, Lidcombe, NSW, Australia.
3 Prince of Wales Medical Research Institute, Randwick, NSW, Australia.
4 ELITE Physiotherapy Exercise & Rehabilitation, Menai, NSW, Australia.

© The Foot & Ankle Journal, 2008