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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 57 - 57
1 May 2012
Mahmood A Shivarathre D Platt S Hennessy M
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Background. Cartilage lesions in chronic lateral ligament deficiency are common with the incidence rates mentioned in the previous literature up to 30%. However, other intra-articular pathologies in the unstable ankle have received little attention. Anterolateral impingement associated with synovitis and scarring is a less recognised feature in the treatment of chronic instability. The aim of our study was to ascertain the incidence of chondral and anterolateral impingement lesions in the symptomatic lateral ligament complex deficiency. Methods. We performed a retrospective study of all consecutive patients who underwent modified Brostrom repair for symptomatic recurrent instability of the ankle. All patients underwent a MRI scan prior to surgery. Arthroscopy was performed in all the patients before lateral ligament reconstruction. Seventy seven patients with 78 ankles were included in the study. Patients who had previous ankle surgery or inflammatory arthropathy were excluded. Data was obtained from clinical and radiological records. Arthroscopic findings were recorded in detail during the surgery. Results. The mean age was 29.8 years (Range 18.2 – 58 yrs). There were 44 females and 34 males in the study. The incidence of chondral lesions were 11.5% (9 out of 78 ankles). The commonest site for chondral defect was the anteromedial talar dome. The incidence of anterolateral impingement which required arthroscopic debridement was 48.7% (38 ankles). A further 10 ankles revealed non-specific synovitis and scarring which was debrided. The sensitivity and specificity of the MRI scans in the assessment of chondral lesions is 91% and 100%. Conclusion. The incidence of chondral lesions in chronic ankle instability is lower than previously published literature. However, soft tissue impingement lesions have a much higher incidence and require debridement. Arthroscopic examination and debridement of impingement prior to lateral ligament reconstruction of the ankle is quintessential in the management of chronic anterolateral instability


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_9 | Pages 13 - 13
16 May 2024
Lambert L Davies M Mangwani J Molloy A Mason L
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Introduction. Anatomic reduction of talar body fractures is critical in restoring congruency to the talocrural joint. Previous studies have indicated a maximum of 25% talar body exposure without malleolar osteotomy. The aim of this study was to investigate the percentage talar body exposure when using the lateral transligamentous approach. Methods. The lateral transligamentous approach to the talus was undertaken in 10 fresh frozen cadaveric specimens by surgeons inexperienced in the approach, following demonstration of the technique. An incision was made on the anterolateral aspect of the ankle augmented by the removal of the anterior talofibular ligament (ATFL) and the calcaneofibular ligament (CFL) from their fibular insertions. A bone lever was then placed behind the lateral aspect of the talus and levered forward with the foot in equinus and inversion. The talus was disarticulated and high resolution images were taken of the talar dome surface. The images were overlain with a reproducible nine-grid division. Accessibility to each zone within the grid with a perpendicular surgical blade was documented. ImageJ software was used to calculate the surface area exposed with each approach. Results. The mean percentage area of talar dome available through the transligamentous approach was 77.3 % (95% confidence interval 73.3, 81.3). In all specimens the complete lateral talar process was accessible, along with the lateral and dorsomedial aspect of the talar neck. This approach gives complete access to Zones 1,2, 3,5 & 6 with partial access to Zones 4,8 & 9. Conclusion. The lateral transligamentous approach to the talus provides significantly greater access to the talar dome as compared to standard approaches. The residual surface area that is inaccessible with this approach is predominantly within Zone 4 and Zone 7, the posteromedial corner


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1349 - 1353
3 Oct 2020
Park CH Song K Kim JR Lee S

Aims. The hypothesis of this study was that bone peg fixation in the treatment of osteochondral lesions of the talus would show satisfactory clinical and radiological results, without complications. Methods. Between September 2014 and July 2017, 25 patients with symptomatic osteochondritis of the talus and an osteochondral fragment, who were treated using bone peg fixation, were analyzed retrospectively. All were available for complete follow-up at a mean 22 of months (12 to 35). There were 15 males and ten females with a mean age of 19.6 years (11 to 34). The clinical results were evaluated using a visual analogue scale (VAS) and the American Orthopaedic Foot and Ankle Society (AOFAS) score preoperatively and at the final follow-up. The radiological results were evaluated using classification described by Hepple et al based on the MRI findings, the location of the lesion, the size of the osteochondral fragment, and the postoperative healing of the lesion. Results. The mean VAS and AOFAS score improved significantly from 6.3 (4 to 8) and 70.6 (44 to 78) preoperatively to 1.6 (0 to 5) and 91.1 (77 to 100) at the final follow-up, respectively (p < 0.001). The classification on MRI was stage 2a in nine patients, stage 3 in 14, and stage 4 in two. The lesion was located on the posteromedial aspect of the dome of the talus in 19 patients, the anterolateral aspect in five, and the centrolateral aspect in one. The mean size of the fragment was 11.2 mm (5 to 20) horizontally, 10.4 mm (7 to 18) vertically, and 5.2 mm (3 to 10) deep, respectively. The postoperative healing state was good in 19 patients and fair in six. Conclusion. Bone peg fixation for osteochondral lesions of the talus showed satisfactory clinical and radiographic results, without complications. This technique could be a good form of treatment for patients with this condition who have an osteochondral fragment. Cite this article: Bone Joint J 2020;102-B(10):1349–1353


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 35 - 35
1 Sep 2012
Choi C Hakim Z Lattouf G Shoaib A
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The treatment of very distal tibial fractures and pilon fractures is difficult. There is a wide variation in the severity of injury and the options for surgical management. Plates and external fixation each have their advantages. This retrospective study looks at complications and technical tips for anterolateral plating. 35 consecutive distal tibial platings were evaluated. The AO classification for each fracture was determined and any patient factors affecting outcome. Outcome variables included time to radiological union, infection rate, wound breakdown rate, and joint movement after treatment. There were 32 anterolateral platings and 3 medial platings. The union rate was 95%. There were two deep infections which required surgical treatment. There were two wound breakdowns, one of which required plastic surgical intervention. Two patients had prominent metalwork, requiring removal. Other complications included deep peroneal nerve palsy, stiffness, and vascular compromise. The complication rates were lower for surgeons operating more frequently on these fractures. Two patients subsequently required bone transport and one required an amputation. The complication rate found was similar to that reported in the literature. The few complications were however very significant for the patient and also for the surgeon as they required bone transport. Complications other than infection occurred in the few cases performed by surgeons low on their learning curve. We present technical tips for surgery. The presence of callus only after mobilisation indicates that union is slow. Anterolateral plating is a viable option for distal tibial fractures, especially 43B fractures. There is a learning curve associated with their use. Complication rates are low overall, but significant consequences can accompany complications. As an alternative to external fixation, distal locking plates are not a pain free option for the surgeon, as well as for the patient


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1443 - 1450
1 Dec 2024
Down B Ferguson J Loizou C McNally M Ramsden A Stubbs D Kendal A

Aims

Calcaneal osteomyelitis remains a difficult condition to treat with high rates of recurrence and below-knee amputation, particularly in the presence of severe soft-tissue destruction. This study assesses the outcomes of single-stage orthoplastic surgical treatment of calcaneal osteomyelitis with large soft-tissue defects.

Methods

A retrospective review was performed of all patients who underwent combined single-stage orthoplastic treatment of calcaneal osteomyelitis (01/2008 to 12/2022). Primary outcome measures were osteomyelitis recurrence and below-knee amputation (BKA). Secondary outcome measures included flap failure, operating time, complications, and length of stay.


The Bone & Joint Journal
Vol. 97-B, Issue 2 | Pages 215 - 220
1 Feb 2015
Soons J Rakhorst HA Ruettermann M Luijsterburg AJM Bos PK Zöphel OT

A total of seven patients (six men and one woman) with a defect in the Achilles tendon and overlying soft tissue underwent reconstruction using either a composite radial forearm flap (n = 3) or an anterolateral thigh flap (n = 4). The Achilles tendons were reconstructed using chimeric palmaris longus (n = 2) or tensor fascia lata (n = 2) flaps or transfer of the flexor hallucis longus tendon (n = 3). Surgical parameters such as the rate of complications and the time between the initial repair and flap surgery were analysed. Function was measured objectively by recording the circumference of the calf, the isometric strength of the plantar flexors and the range of movement of the ankle. The Achilles tendon Total Rupture Score (ATRS) questionnaire was used as a patient-reported outcome measure. Most patients had undergone several previous operations to the Achilles tendon prior to flap surgery. The mean time to flap surgery was 14.3 months (2.1 to 40.7). At a mean follow-up of 32.3 months (12.1 to 59.6) the circumference of the calf on the operated lower limb was reduced by a mean of 1.9 cm (. sd. 0.74) compared with the contralateral limb (p = 0.042). The mean strength of the plantar flexors on the operated lower limb was reduced to 88.9% of that of the contralateral limb (p = 0.043). There was no significant difference in the range of movement between the two sides (p = 0.317). The mean ATRS score was 72 points (. sd. 20.0). One patient who had an initial successful reconstruction developed a skin defect of the composite flap 12 months after free flap surgery and this resulted in recurrent infections, culminating in transtibial amputation 44 months after reconstruction. . These otherwise indicate that reconstruction of the Achilles tendon combined with flap cover results in a successful and functional reconstruction. Cite this article: Bone Joint J 2015;97-B:215–20


Aims

Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm2. However, some patients have persistent pain and limitation of movement in the early postoperative period. No studies have investigated the combined treatment of microfracture and shortwave treatment in these patients. The aim of this prospective single-centre, randomized, double-blind, placebo-controlled trial was to compare the outcome in patients treated with arthroscopic microfracture combined with radial extracorporeal shockwave therapy (rESWT) and arthroscopic microfracture alone, in patients with ostechondritis of the talus.

Methods

Patients were randomly enrolled into two groups. At three weeks postoperatively, the rESWT group was given shockwave treatment, once every other day, for five treatments. In the control group the head of the device which delivered the treatment had no energy output. The two groups were evaluated before surgery and at six weeks and three, six and 12 months postoperatively. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. Secondary outcome measures included a visual analogue scale (VAS) score for pain and the area of bone marrow oedema of the talus as identified on sagittal fat suppression sequence MRI scans.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1099 - 1107
1 Oct 2023
Henry JK Shaffrey I Wishman M Palma Munita J Zhu J Cody E Ellis S Deland J Demetracopoulos C

Aims

The Vantage Total Ankle System is a fourth-generation low-profile fixed-bearing implant that has been available since 2016. We aimed to describe our early experience with this implant.

Methods

This is a single-centre retrospective review of patients who underwent primary total ankle arthroplasty (TAA) with a Vantage implant between November 2017 and February 2020, with a minimum of two years’ follow-up. Four surgeons contributed patients. The primary outcome was reoperation and revision rate of the Vantage implant at two years. Secondary outcomes included radiological alignment, peri-implant complications, and pre- and postoperative patient-reported outcomes.


The Bone & Joint Journal
Vol. 100-B, Issue 5 | Pages 590 - 595
1 May 2018
Sawa M Nakasa T Ikuta Y Yoshikawa M Tsuyuguchi Y Kanemitsu M Ota Y Adachi N

Aims. The aim of this study was to evaluate antegrade autologous bone grafting with the preservation of articular cartilage in the treatment of symptomatic osteochondral lesions of the talus with subchondral cysts. Patients and Methods. The study involved seven men and five women; their mean age was 35.9 years (14 to 70). All lesions included full-thickness articular cartilage extending through subchondral bone and were associated with subchondral cysts. Medial lesions were exposed through an oblique medial malleolar osteotomy, and one lateral lesion was exposed by expanding an anterolateral arthroscopic portal. After refreshing the subchondral cyst, it was grafted with autologous cancellous bone from the distal tibial metaphysis. The fragments of cartilage were fixed with 5-0 nylon sutures to the surrounding cartilage. Function was assessed at a mean follow-up of 25.3 months (15 to 50), using the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot outcome score. The radiological outcome was assessed using MRI and CT scans. Results. The mean AOFAS score improved from 65.7 (47 to 81) preoperatively to 92 (90 to 100) at final follow-up, with 100% patient satisfaction. The radiolucent area of the cysts almost disappeared on plain radiographs in all patients immediately after surgery, and there were no recurrences at the most recent follow-up. The medial malleolar screws were removed in seven patients, although none had symptoms. At this time, further arthroscopy was undertaken, when it was found that the mean International Cartilage Repair Society (ICRS) arthroscopic score represented near-normal cartilage. Conclusion. Autologous bone grafting with fixation of chondral fragments preserves the original cartilage in the short term, and could be considered in the treatment for adult patients with symptomatic osteochondral defect and subchondral cysts. Cite this article: Bone Joint J 2018;100-B:590–5


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 11 | Pages 1457 - 1461
1 Nov 2008
Lee K Chung J Song E Seon J Bai L

We describe the surgical technique and results of arthroscopic subtalar release in 17 patients (17 feet) with painful subtalar stiffness following an intra-articular calcaneal fracture of Sanders’ type II or III. The mean duration from injury to arthroscopic release was 11.3 months (6.4 to 36) and the mean follow-up after release was 16.8 months (12 to 25). The patient was positioned laterally and three arthroscopic portals were placed anterolaterally, centrally and posterolaterally. The sinus tarsi and lateral gutter were debrided of fibrous tissue and the posterior talocalcaneal facet was released. In all, six patients were very satisfied, eight were satisfied and three were dissatisfied with their results. The mean American Orthopaedic Foot and Ankle Society ankle-hindfoot score improved from a mean of 49.4 points (35 to 66) pre-operatively to a mean of 79.6 points (51 to 95). All patients reported improvement in movement of the subtalar joint. No complications occurred following operation, but two patients subsequently required subtalar arthrodesis for continuing pain. In the majority of patients a functional improvement in hindfoot function was obtained following arthroscopic release of the subtalar joint for stiffness and pain secondary to Sanders type II and III fractures of the calcaneum


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 68 - 75
1 Jan 2022
Harris NJ Nicholson G Pountos I

Aims

The ideal management of acute syndesmotic injuries in elite athletes is controversial. Among several treatment methods used to stabilize the syndesmosis and facilitate healing of the ligaments, the use of suture tape (InternalBrace) has previously been described. The purpose of this study was to analyze the functional outcome, including American Orthopaedic Foot & Ankle Society (AOFAS) scores, knee-to-wall measurements, and the time to return to play in days, of unstable syndesmotic injuries treated with the use of the InternalBrace in elite athletes.

Methods

Data on a consecutive group of elite athletes who underwent isolated reconstruction of the anterior inferior tibiofibular ligament using the InternalBrace were collected prospectively. Our patient group consisted of 19 elite male athletes with a mean age of 24.5 years (17 to 52). Isolated injuries were seen in 12 patients while associated injuries were found in seven patients (fibular fracture, medial malleolus fracture, anterior talofibular ligament rupture, and posterior malleolus fracture). All patients had a minimum follow-up period of 17 months (mean 27 months (17 to 35)).


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 696 - 703
1 Apr 2021
Clough TM Ring J

Aims

We report the medium-term outcomes of a consecutive series of 118 Zenith total ankle arthroplasties (TAAs) from a single, non-designer centre.

Methods

Between December 2010 and May 2016, 118 consecutive Zenith prostheses were implanted in 114 patients. Demographic, clinical, and patient-reported outcome measures (PROMs) data were collected. The endpoint of the study was failure of the implant requiring revision of one or all of the components. Kaplan-Meier survival curves were generated with 95% confidence intervals (CIs) and the rate of failure calculated for each year.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 51 - 51
1 May 2012
Chaudhry S Prem H
Full Access

Painful peroneal spastic flatfeet without coalition or other known etiologies in adolescence, remains a difficult condition to treat. We present eight such cases with radiological and surgical evidence of bony abnormalities in the lateral subtalar region just anterior to the posterior facet. All patients had presented as tertiary referrals with recalcitrant pain and had undergone a trial of orthotics and physiotherapy. Diagnostic workup included a clinical and radiographic evaluation. Clinical examination consisted of gait examination, foot alignment, range of motion, torsional profile of the lower limbs and marking of symptomatic foci. All patients had standing weightbearing anteroposterior and lateral projections of the foot and ankle, CT and/or MRI scans of the foot. Coalitions and other known intra-articular pathologies like subtalar arthritis were ruled out. All patients had bilateral flatfeet but unilateral peroneal spasm. All patients had an accessory anterolateral talar facet (ATF) which was arising as an anterior and distal extension of the lateral process of the talus. This caused lateral impingement between the facet and the calcaneum, confirmed by bone edema around the sinus tarsi and marked at the apex of the angle of Gissane on MRI scans. All patients had stiff subtalar joints with very limited movement under anaesthesia, indicating peroneal muscle contracture. Patients were treated with a combination of facet excision, fractional peroneal and gastrosoleus lengthening and calcaneal lengthening to correct the flatfoot and prevent lateral impingement


The Bone & Joint Journal
Vol. 100-B, Issue 10 | Pages 1359 - 1363
1 Oct 2018
Chiu Y Chung T Wu C Tsai K Jou I Tu Y Ma C

Aims

This study reports the outcomes of a technique of soft-tissue coverage and Chopart amputation for severe crush injuries of the forefoot.

Patients and Methods

Between January 2012 to December 2016, 12 patients (nine male; three female, mean age 38.58 years; 26 to 55) with severe foot crush injury underwent treatment in our institute. All patients were followed-up for at least one year. Their medical records, imaging, visual analogue scale score, walking ability, complications, and functional outcomes one year postoperatively based on the American Orthopedic Foot and Ankle Society (AOFAS) and 36-Item Short-Form Health Survey (SF-36) scores were reviewed.


The Bone & Joint Journal
Vol. 99-B, Issue 4 | Pages 489 - 493
1 Apr 2017
Sadamasu A Yamaguchi S Nakagawa R Kimura S Endo J Akagi R Sasho T

Aims

The purposes of this study were to clarify first, the incidence of peroneal tendon dislocation in patients with a fracture of the talus and second the factors associated with peroneal tendon dislocation.

Patients and Methods

We retrospectively examined 30 patients (30 ankles) with a mean age of 37.5 years, who had undergone internal fixation for a fracture of the talus. Independent examiners assessed for peroneal tendon dislocation using the pre-operative CT images. The medical records were also reviewed for the presence of peroneal tendon dislocation. The associations between the presence of dislocation with the patient characteristics or radiological findings, including age, mechanism of injury, severity of fracture, and fleck sign, were assessed using Fisher’s exact tests.


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 874 - 883
1 Jul 2016
Ballal MS Pearce CJ Calder JDF

Sporting injuries around the ankle vary from simple sprains that will resolve spontaneously within a few days to severe injuries which may never fully recover and may threaten the career of a professional athlete. Some of these injuries can be easily overlooked altogether or misdiagnosed with potentially devastating effects on future performance. In this review article, we cover some of the common and important sporting injuries involving the ankle including updates on their management and outcomes.

Cite this article: Bone Joint J 2016;98-B:874–83.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 9 | Pages 1191 - 1196
1 Sep 2009
Pagenstert GI Barg A Leumann AG Rasch H Müller-Brand J Hintermann B Valderrabano V

The precise localisation of osteoarthritic changes is crucial for selective surgical treatment. Single photon-emission CT-CT (SPECT-CT) combines both morphological and biological information. We hypothesised that SPECT-CT increased the intra- and interobserver reliability to localise increased uptake compared with traditional evaluation of CT and bone scanning together. We evaluated 20 consecutive patients with pain of uncertain origin in the foot and ankle by radiography and SPECT-CT, available as fused SPECT-CT, and by separate bone scanning and CT. Five observers assessed the presence or absence of arthritis. The images were blinded and randomly ordered. They were evaluated twice at an interval of six weeks. Kappa and multirater kappa values were calculated.

The mean intraobserver reliability for SPECT-CT was excellent (κ = 0.86; 95% CI 0.81 to 0.88) and significantly higher than that for CT and bone scanning together. SPECT-CT had significantly higher interobserver agreement, especially when evaluating the naviculocuneiform and tarsometatarsal joints.

SPECT-CT is useful in localising active arthritis especially in areas where the number and configuration of joints are complex.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 8 | Pages 1049 - 1054
1 Aug 2008
Han SH Choi WJ Kim S Kim S Lee JW

We undertook a retrospective review of 24 arthroscopic procedures in patients with symptomatic ossicles around the malleoli of the ankle. Most of the patients had a history of injury and localised tenderness in the area coinciding with the radiological findings. Contrast-enhanced three-dimensional fast-spoiled gradient-echo MRI was performed and the results compared with the arthroscopic findings. An enhanced signal surrounding soft tissue corresponding to synovial inflammation and impingement was found in 20 patients (83%). The arthroscopic findings correlated well with those of our MRI technique and the sensitivity was estimated to be 91%. At a mean follow-up of 30.5 months (20 to 86) the mean American Orthopaedic Foot and Ankle Society score improved from 74.5 to 93 points (p < 0.001). Overall, the rate of patient satisfaction was 88%.

Our results indicate that symptomatic ossicles of the malleoli respond well to arthroscopic treatment.


The Bone & Joint Journal
Vol. 95-B, Issue 3 | Pages 378 - 383
1 Mar 2013
Kim BS Choi WJ Kim J Lee JW

We report the incidence and intensity of persistent pain in patients with an otherwise uncomplicated total ankle replacement (TAR). Arthroscopic debridement was performed in selected cases and the clinical outcome was analysed.

Among 120 uncomplicated TARs, there was persistent pain with a mean visual analogue scale (VAS) of 2.7 (0 to 8). The intensity of pain decreased in 115 ankles (95.8%). Exercise or walking for more than 30 minutes was the most common aggravating factor (62 ankles, 68.1%). The character of the pain was most commonly described as dull (50 ankles, 54.9%) and located on the medial aspect of the joint (43 ankles, 47.3%).

A total of seven ankles (5.8%) underwent subsequent arthroscopy. These patients had local symptoms and a VAS for pain ≥ 7 on exertion. Impingement with fibrosis and synovitis was confirmed. After debridement, the median VAS decreased from 7 to 3 and six patients were satisfied. The median VAS for pain and the American Orthopaedic Foot and Ankle Society score of the ankles after debridement was similar to that of the uncomplicated TARs (p = 0.496 and p = 0.066, respectively).

Although TAR reduces the intensity of pain, residual pain is not infrequent even in otherwise uncomplicated TARs and soft-tissue impingement is the possible cause.

Cite this article: Bone Joint J 2013;95-B:378–83.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 10 | Pages 1322 - 1325
1 Oct 2009
El-Gafary KAM Mostafa KM Al-adly WY

Charcot osteoarthropathy of the foot is a chronic and progressive disease of bone and joint associated with a risk of amputation. The main problems encountered in this process are osteopenia, fragmentation of the bones of the foot and ankle, joint subluxation or even dislocation, ulceration of the skin and the development of deep sepsis. We report our experience of a series of 20 patients with Charcot osteoarthropathy of the foot and ankle treated with an Ilizarov external fixator. The mean age of the group was 30 years (21 to 50). Diabetes mellitus was the underlying cause in 18 patients. Five had chronic ulcers involving the foot and ankle. Each patient had an open lengthening of the tendo Achillis with excision of all necrotic and loose bone from the ankle, subtalar and midtarsal joints when needed. The resulting defect was packed with corticocancellous bone graft harvested from the iliac crest and an Ilizarov external fixator was applied. Arthrodesis was achieved after a mean of 18 weeks (15 to 20), with healing of the skin ulcers. Pin track infection was not uncommon, but no frame had to be removed before the arthrodesis was sound.

Every patient was able to resume wearing regular shoes after a mean of 26.5 weeks (20 to 45).