Cost-Utility Analysis of Total Ankle Replacement Compared with Ankle Arthrodesis for Patients Aged 50-85 Years with End-Stage Ankle Osteoarthritis: The TARVA Study.

BACKGROUND: Patients with end-stage ankle osteoarthritis suffer from reduced mobility and quality of life and the main surgical treatments are total ankle replacement (TAR) and ankle fusion (AF). OBJECTIVES: Our aim was to calculate the mean incremental cost per quality-adjusted life-year (QALY) of TAR compared with AF in patients with end-stage ankle osteoarthritis, over 52 weeks and over the patients' lifetime. METHOD: We conducted a cost-utility analysis of 282 participants from 17 UK centres recruited to a randomised controlled trial (TARVA). QALYs were calculated using index values from EQ-5D-5L. Resource use information was collected from case report forms and self-completed questionnaires. Primary analysis was within-trial analysis from the National Health Service (NHS) and Personal Social Services (PSS) perspective, while secondary analyses were within-trial analysis from wider perspective and long-term economic modelling. Adjustments were made for baseline resource use and index values. RESULTS: Total cost at 52 weeks was higher in the TAR group compared with the AF group, from the NHS and PSS perspective (mean adjusted difference £2539, 95% confidence interval [CI] £1142, £3897). The difference became very small from the wider perspective (£155, 95% CI -  £1947, £2331). There was no significant difference between TAR and AF in terms of QALYs (mean adjusted difference 0.02, 95% CI -  0.015, 0.05) at 52 weeks post-operation. The incremental cost-effectiveness ratio (ICER) was £131,999 per QALY gained 52 weeks post-operation. Long-term economic modelling resulted in an ICER of £4200 per QALY gained, and there is a 69% probability of TAR being cost effective at a cost-effectiveness threshold of £20,000 per QALY gained. CONCLUSION: TAR does not appear to be cost effective over AF 52 weeks post-operation. A decision model suggests that TAR can be cost effective over the patients' lifetime but there is a need for longer-term prospectively collected data. Clinical trial registration ISRCTN60672307 and ClinicalTrials.gov NCT02128555.

Two to Five-Year Outcomes of Total Ankle Arthroplasty with the Infinity Fixed-Bearing Implant: A Concise Follow-up of a Previous Report.

LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

The predictive value of vascular calcification on plain radiographs of the ankle to diagnose diabetes mellitus.

INTRODUCTION: There are nearly 500,000 people with undiagnosed diabetes mellitus in the UK. A common complication of diabetes is vascular calcification. The incidental finding of vascular calcification on plain radiographs in patients with undiagnosed diabetes has the potential to alter patient management. We hypothesised that the presence of vascular calcification on plain radiographs of the foot may predict the diagnosis of diabetes and aimed to determine the positive predictive value of vascular calcification to diagnose diabetes. METHODS: A retrospective case control study compared 130 diabetic patients to 130 non-diabetic patients that were matched for age and gender. The presence of vascular calcification in anterior, posterior or plantar vessels was measured on plain radiographs. McNemar's Chi-squared test and positive predictive values were calculated. Conditional logistic regression models estimated the association between calcification and diabetes RESULTS: The overall mean age was 58.0 % and 31.5 % were females. 89.2 % of those with diabetes had calcification present, and 23.1 % in those who did not have diabetes had calcification. McNemar's test for independence gives p < 0.001. Calcification in both anterior and posterior vessels predicts diabetes with a positive predictive value of 91.2 % (95 % CI 76.9-97.0 %). The odds ratio for having diabetes is 78 (95 % CI: 7.8 - 784) times higher in a person who has calcification in the blood vessels of their ankle than in a person without calcification after adjusting for confounders CONCLUSION: This study has demonstrated that vascular calcification in the anterior and posterior blood vessels is over 90 % predictive of a diagnosis of diabetes. This screening test could be used in future clinics when interpreting radiographs, aiding in the diagnosis of diabetes and altering patient management.

A Comparison of Fibula Pro-Tibia Fixation Versus Hindfoot Nailing for Unstable Fractures of the Ankle in Those Older Than 60 Years.

BACKGROUND: Ankle fractures in the elderly are an increasing problem, with poor outcomes reported. Operative options for patients with suspected osteoporosis and needing to bear weight to ambulate can include hindfoot intramedullary nail (IMN) or fibula pro-tibia fixation (FPT). FPT involves passing 2 or more screws through a lateral fibula plate, crossing the fibular into the tibia, with 1 or more screws proximal to the incisura. We compared the outcomes of these 2 techniques. METHOD: A retrospective review identified 68 patients aged over 60 years with unstable ankle fractures, treated with IMN or FPT. Primary outcome was surgical reoperation/revision rate, secondary outcomes included complications, length of stay, and functional status. Results: There were no significant differences in demographics between IMN and FPT. Revision rates were higher in IMN compared with FPT (P < .0001). IMN patients postoperatively had longer hospital stays (P = .02), longer follow-up times (P = .008), and higher rates of delayed wound healing (P = .03) and nonunion (P = .001). Multivariate analysis identified fixation and age to affect revision rates. CONCLUSION: Outcomes were worse in the IMN group compared with FPT. We believe both techniques have a role in the management of elderly ankle fractures, but patient selection is key. We suggest that FPT should be the first-choice technique when soft tissues permit. LEVELS OF EVIDENCE: Level III.

Total Ankle Replacement Versus Arthrodesis for End-Stage Ankle Osteoarthritis: A Randomized Controlled Trial.

BACKGROUND: End-stage ankle osteoarthritis causes severe pain and disability. There are no randomized trials comparing the 2 main surgical treatments: total ankle replacement (TAR) and ankle fusion (AF). OBJECTIVE: To determine which treatment is superior in terms of clinical scores and adverse events. DESIGN: A multicenter, parallel-group, open-label randomized trial. (ISRCTN registry number: 60672307). SETTING: 17 National Health Service trusts across the United Kingdom. PATIENTS: Patients with end-stage ankle osteoarthritis, aged 50 to 85 years, and suitable for either procedure. INTERVENTION: Patients were randomly assigned to TAR or AF surgical treatment. MEASUREMENTS: The primary outcome was change in Manchester-Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores between baseline and 52 weeks after surgery. No blinding was possible. RESULTS: Between 6 March 2015 and 10 January 2019, a total of 303 patients were randomly assigned; mean age was 68 years, and 71% were men. Twenty-one patients withdrew before surgery, and 281 clinical scores were analyzed. At 52 weeks, the mean MOXFQ-W/S scores improved for both groups. The adjusted difference in the change in MOXFQ-W/S scores from baseline was -5.6 (95% CI, -12.5 to 1.4), showing that TAR improved more than AF, but the difference was not considered clinically or statistically significant. The number of adverse events was similar between groups (109 vs. 104), but there were more wound healing issues in the TAR group and more thromboembolic events and nonunion in the AF group. The symptomatic nonunion rate for AF was 7%. A post hoc analysis suggested superiority of fixed-bearing TAR over AF (-11.1 [CI, -19.3 to -2.9]). LIMITATION: Only 52-week data; pragmatic design creates heterogeneity of implants and surgical techniques. CONCLUSION: Both TAR and AF improve MOXFQ-W/S and had similar clinical scores and number of harms. Total ankle replacement had greater wound healing complications and nerve injuries, whereas AF had greater thromboembolism and nonunion, with a symptomatic nonunion rate of 7%. PRIMARY FUNDING SOURCE: National Institute for Health and Care Research Heath Technology Assessment Programme.

Subtalar Arthrodesis Union Rates With and Without Adjacent Ankle Arthrodesis.

BACKGROUND: Subtalar arthrodesis is the surgical procedure commonly performed to treat subtalar arthritis. Subtalar arthrodesis may have a higher nonunion rate if there is a preexisting adjacent joint arthrodesis. The aim of this retrospective cohort study was to compare the subtalar arthrodesis union rate of patients with native tibiotalar joints to that of patients with prior tibiotalar arthrodesis. The secondary aim was to assess risk factors for nonunion. METHODS: A retrospective cohort study of consecutive patients that underwent a subtalar arthrodesis in a single center between 2010 and 2020. The primary outcome of union was determined based on bridging callus on radiographs and clinical symptoms. If there was uncertainty, then a nonweightbearing CT was acquired. Chi-squared test and Mann-Whitney tests compared differences in demographics and risk factors for nonunion between groups. A logistical regression model was performed to determine risk factors for nonunion. RESULTS: Eighteen patients had an adjacent ankle arthrodesis and 53 patients did not. The successful subtalar arthrodesis union rate in those with a preexisting ankle joint arthrodesis (44.4%) was approximately half that in those without an ankle joint arthrodesis (86.8%) (P < .001). On multivariate logistic regression, an adjacent ankle arthrodesis was the only significant risk factor for nonunion. The odds ratio of nonunion of the subtalar joint with an adjacent ankle arthrodesis present was 4.90 (95% CI 1.02-23.56) compared to a subtalar arthrodesis with a native ankle joint. In addition, 9.4% of patients without an ankle arthrodesis underwent a revision subtalar arthrodesis compared with 44.4% of those with an adjacent ankle arthrodesis (P = .001). CONCLUSION: In our study, we found that patients undergoing a subtalar arthrodesis with an adjacent ankle arthrodesis have a significantly increased risk of nonunion compared with those undergoing a subtalar arthrodesis with a native ankle. Patients with a previously fused ankle need counseling about the high risk of nonunion and potential additional surgery.

Avoidance of injury to the posterior neurovascular bundle during total ankle arthroplasty - A simple technical tip.

Iatrogenic nerve injury to the tibial nerve is a serious but avoidable complication of total ankle replacements and may be under-reported as it may go unrecognised or thought to be due to tarsal tunnel syndrome. The tibial nerve is particularly vulnerable during the saw cuts at the posteromedial corner without appropriate protection. Prior to drilling the tibial and talar pins of the adjustment block for the Infinity ankle replacement we perform a 2 cm incision behind the medial malleolus. The tibialis posterior tendon sheath is identified and incised. A periosteal elevator is used to develop a plane between the back of the tibia and the tibialis posterior tendon and then exchanged for a mini Hohmann retractor protecting the neurovascular bundle. This allows us to drill the pins and saw cuts safely. The Hohmann retractor can be felt at the tip of the saw blade providing reassurance that the blade is not too deep. Our technique has not previously been reported in the literature. It acts as a simple reproducible way of avoiding injury to structures at the back of the ankle joint.

A new classification for Freiberg's disease.

INTRODUCTION: Freiberg's osteochondrosis is an uncommon cause of foot pain. Following a national survey circulated by the British Foot and Ankle Society it was found that no classification is used to guide surgical treatment. This study aimed to create a simple, reproducible CT based classification to preoperatively plan whether an osteotomy is required. METHODS: A retrospective review of 24 CT scans of new Freiberg's diseasediagnoses over a 10 year period was conducted. These images were assigned a study number and anonymised. The scans were then reviewed in their entirety by three independent specialists who determined whether an osteotomy would be of benefit. The sagittal CT slice that displayed the widest portion of proximal articular margin of the proximal phalanx was identified and divided the articular surface into 2 zones - plantar and dorsal and this formed the basis for our classification. These sagittal slices were then reviewed independently by two surgeons to determine if patients had disease in one or both zones and re-reviewed two weeks later to assess intra-observer reliability. RESULTS: All 24 cases involved the second metatarsal. From reviewing the sagittal CT slices, it was felt that 18 patients were suitable for osteotomy and 6 were suitable for debridement +/- arthroplasty alone. The current classification demonstrated that 18 patients had disease confined to zone 1 only and the remaining patients had disease in both zones. Inter-observer reliability assessment had 95.8% agreement (Krippendorff's Alpha 0.897). Intra-observer reliability was 100%. Correlation of those observed to have isolated zone 1 disease and suitability for osteotomy was absolute (Pearson r = 1). CONCLUSION: Dividing the metatarsal head into two zones on the widest sagittal slice of the CT scan offers an easy reproducible way to preoperatively plan surgical treatment for Freiberg's osteochondrosis. Patients with isolated zone 1 disease should be suitable for an osteotomy.

Fibula nail fixation in ankle fractures with significant soft tissue compromise: a retrospective cohort study.

PURPOSE: Intramedullary fixation of lateral malleolar fractures has increased in popularity recently with the introduction of the fibula nail. It has been proposed as an alternative fixation method in fractures to minimise soft tissue injury. The aim of this study was to evaluate the clinical and patient-reported outcomes of those who had an ankle fracture with concurrent significant soft tissue damage, treated with a fibula nail. METHODS: Details of patients who were managed at our institution using a fibula nail were obtained from the trauma database. The Acumed Fibula Rod System (FRS) was used in all cases. Those who were less than 12 months following injury were excluded. Patients attended a follow-up clinic for measurement of range of movement, radiographs, and to complete MOX-FQ and EQ-5D questionnaires. RESULTS: Twenty patients were identified. Eleven attended for review in person, and a further eight completed questionnaires (questionnaire response rate 95%). The mean age was 59 years (range 19-91). Twelve fractures were open, all of which were initially managed using an external fixator. One patient developed deep infection necessitating fusion. The mean MOX-FQ and EQ-5D scores were 53.6 and 0.649, respectively, at a median of 40 months post-injury. The mean EQ-VAS was 70. The range of movement of the affected side was significantly less than the unaffected side (p < 0.001 on paired t-test). CONCLUSION: This study suggests that the FRS offers a reliable and acceptable alternative fixation technique for patients who have significant soft tissue injuries.

Open Ankle Arthrodesis: a Systematic Review of Approaches and Fixation Methods.

BACKGROUND: Open ankle arthrodesis (OAA) remains the most widely used operation in end-stage ankle osteoarthritis. However, there is a large variation in terms of approach and fixation methods. The aim of this systematic review was to assess the effect of different approaches and fixation methods on the union rate, complication rate and functional outcome in OAA. METHODS: A search of the online databases PubMed, Embase, and Cochrane library was performed to identify patients who underwent OAA with screw- and/or plate-fixation. RESULTS: We identified 38 studies, including 1250 patients (1290 ankles). The union rate was 98% (95% CI 0.95-0.99) for the anterior, 96% (95% CI 0.92-0.98) for the lateral and 96% (95% CI 0.68-1.00) for the combined medial/lateral approach. Screw-fixation achieved an overall union rate of 96% (95% CI 0.93-0.98) and plate-fixation 99% (95% CI 0.96-0.99). The overall complication rate was 14%, 16% and 31% for the anterior, lateral and combined medial/lateral approaches respectively. It stood at 18% for screw-fixation and 9% for plate-fixation. The infection rate was 4%, 6% and 8% for the anterior, lateral and combined approaches respectively. Screw-fixation had an infection rate of 6% and plate-fixation 3%. The postoperative AOFAS scores were 76.8, 76.5 and 67.6 for the anterior, lateral and combined approaches respectively and 74.9 for screw- compared to 78.5 for plate-fixation. These differences did not reach statistical significance. CONCLUSION: This study, the first of its kind, found little difference in terms of results between approach and fixation method used in OAA. LEVEL OF EVIDENCE: Level IIa.

Midfoot Charcot Neuro-arthropathy Precipitated by First or Fifth ray Amputation.

BACKGROUND: Charcot Neuro-arthropathy (CN) can occur spontaneously in a neuropathic foot but is often precipitated by an insult to the foot, such as trauma. We noted an association between 1st and 5th ray amputations and the development of midfoot CN in our clinics. We therefore set out to analyse our data over a 6-year period to evaluate and improve our practice. METHODS: Our project encompassed all diabetic adults with peripheral neuropathy undergoing an amputation of the first or fifth ray between January 2013 and January 2019. Patient demographics, stump length, progression to CN, imaging reports, the need for further operative management, length of stay and operating specialty were collected. Cases that developed CN after 1st or 5th ray amputation ("CN group") were compared with a cohort composed of patients that did not ("non-CN group"). RESULTS: We identified 92 patients (98 surgical episodes) who had previous 1st or 5th ray amputations [77 males (83.7%), 15 females (16.3%), mean age 61.5 ± 13.5]. Midfoot CN developed in 16 cases (17.4%; nine following 1st ray and seven following 5th ray amputation). This represented 30.9% of all our new CN cases. CN was diagnosed within six months in six cases and up to three years in the remaining 12. Five of the 1st ray amputations were conducted with a stump length of ≤10 mm from the tarsometatarsal joint and a further one had resorbed down to it before the Charcot process. Three of the 5th ray amputations were carried out leaving a stump length ≤25 mm. Receiver Operator Curve (ROC) analysis showed no obvious diagnostic value of stump length in predicting CN (area under the curve 0.42 (95% CI 0.26 - 0.59)). Following a logistic regression analysis into effect of age, gender and peripheral vascular disease, only age was found to significantly affect the risk of developing CN (Nagelkerke R2 = 0.122, p = 0.013). CONCLUSION: This is the first report of midfoot CN developing after 1st or 5th ray amputations. The foot could be destabilised following these procedures, leading to increased pressures across the midfoot. Our small sample was unable to demonstrate a significant correlation between stump length and CN risk. However, more work is needed to ascertain this. Meanwhile, we believe this translates clinically into a need for enhanced foot protection following 1st and 5th ray amputations in our practice.

The impact of COVID-19 on morbidity and mortality in neck of femur fracture patients: a prospective case-control cohort study.

AIMS: Within the UK, around 70,000 patients suffer neck of femur (NOF) fractures annually. Patients presenting with this injury are often frail, leading to increased morbidity and a 30-day mortality rate of 6.1%. COVID-19 infection has a broad spectrum of clinical presentations with the elderly, and those with pre-existing comorbidities are at a higher risk of severe respiratory compromise and death. Further increased risk has been observed in the postoperative period. The aim of this study was to assess the impact of COVID-19 infection on the complication and mortality rates of NOF fracture patients. METHODS: All NOF fracture patients presenting between March 2020 and May 2020 were included. Patients were divided into two subgroup: those with or without clinical and/or laboratory diagnosis of COVID-19. Data were collected on patient demographics, pattern of injury, complications, length of stay, and mortality. RESULTS: Overall, 132 patients were included. Of these, 34.8% (n = 46) were diagnosed with COVID-19. Bacterial pneumonia was observed at a significantly higher rate in those patients with COVID-19 (56.5% vs 15.1%; p =< 0.000). Non respiratory complications such as acute kidney injury (30.4% vs 9.3%; p =0.002) and urinary tract infection (10.9% vs 3.5%; p =0.126) were also more common in those patients with COVID-19. Length of stay was increased by a median of 21.5 days in patients diagnosed with COVID-19 (p < 0.000). 30-day mortality was significantly higher in patients with COVID-19 (37.0%) when compared to those without (10.5%; p <0.000). CONCLUSION: This study has shown that patients with a neck of femur fracture have a high rate of mortality and complications such as bacterial pneumonia and acute kidney injury when diagnosed with COVID-19 within the perioperative period. We have demonstrated the high risk of in hospital transmission of COVID-19 and the association between the infection and an increased length of stay for the patients affected.Cite this article: Bone Joint Open 2020;1-11:669-675.

Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus.

BACKGROUND:: A prospective, randomized, noninferiority clinical trial of synthetic cartilage implant hemiarthroplasty for hallux rigidus demonstrated functional outcomes and safety equivalent to first metatarsophalangeal (MTP) joint arthrodesis at 24 months. We prospectively assessed safety and efficacy outcomes for synthetic cartilage implant hemiarthroplasty at a minimum of 5 years. METHODS:: Of 135 eligible patients from the original trial, 112 (83.0%) were enrolled (mean age, 58.2 ± 8.8 years; 87 females). Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL), and FAAM Sports subscales were completed preoperatively and 2 and 5 years postoperatively. Great toe active dorsiflexion, weightbearing radiographs, secondary procedures, and safety parameters were also evaluated. RESULTS:: At 24 months, 14/152 (9.2%) patients had undergone implant removal and conversion to arthrodesis. In years 2 to 5, 9/119 (7.6%) patients underwent implant removal and conversion to arthrodesis. At mean 5.8 ± 0.7 (range, 4.4-8.0) years' follow-up, pain VAS, FAAM ADL, and FAAM Sports scores improved by 57.9 ± 18.6 points, 33.0 ± 17.6 points, and 47.9 ± 27.1 points, respectively, from baseline. Clinically significant changes in VAS pain, FAAM ADL, and FAAM Sports were reported by 103/106 (97.2%), 95/105 (90.5%), and 97/104 (93.3%) patients, respectively. Patient-reported outcomes at 24 months were maintained at 5.8 years in patients who were not revised. Active MTP joint peak dorsiflexion was maintained. Ninety-nine of 106 (93.4%) patients would have the procedure again. CONCLUSION:: Clinical and safety outcomes for synthetic cartilage implant hemiarthroplasty observed at 2 years were maintained at 5.8 years. The implant remains a viable treatment option to decrease pain, improve function, and maintain motion for advanced hallux rigidus. LEVEL OF EVIDENCE:: Level IV, case series.

Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: A comparison of operative and recovery time.

BACKGROUND: First metatarsophalangeal joint (MTPJ1) hemiarthroplasty using a novel synthetic cartilage implant was as effective and safe as MTPJ1 arthrodesis in a randomized clinical trial. We retrospectively evaluated operative time and recovery period for implant hemiarthroplasty (n=152) and MTPJ1 arthrodesis (n=50). METHODS: Perioperative data were assessed for operative and anaesthesia times. Recovery and return to function were prospectively assessed with the Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) subscales and SF-36 Physical Functioning (PF) subscore. RESULTS: Mean operative time for hemiarthroplasty was 35±12.3min and 58±21.5min for arthrodesis (p<0.001). Anaesthesia duration was 28min shorter with hemiarthroplasty (p<0.001). At weeks 2 and 6 postoperative, hemiarthroplasty patients demonstrated clinically and statistically significantly higher FAAM Sport, FAAM ADL, and SF-36 PF subscores versus arthrodesis patients. CONCLUSION: MTPJ1 hemiarthroplasty with a synthetic cartilage implant took less operative time and resulted in faster recovery than arthrodesis. LEVEL OF EVIDENCE: III, Retrospective case control study.

Correlation of Hallux Rigidus Grade With Motion, VAS Pain, Intraoperative Cartilage Loss, and Treatment Success for First MTP Joint Arthrodesis and Synthetic Cartilage Implant.

BACKGROUND: Grading systems are used to assess severity of any condition and as an aid in guiding treatment. This study examined the relationship of baseline motion, pain, and observed intraoperative cartilage loss with hallux rigidus grade. METHODS: A prospective, randomized study examining outcomes of arthrodesis compared to synthetic cartilage implant was performed. Patients underwent preoperative clinical examination, radiographic assessment, hallux rigidus grade assignment, and intraoperative assessment of cartilage loss. Visual analog scale (VAS) score for pain was obtained preoperatively and at 24 months. Correlation was made between active peak dorsiflexion, VAS pain, cartilage loss, and hallux rigidus grade. Fisher's exact test was used to assess grade impact on clinical success ( P < .05). RESULTS: In 202 patients, 59 (29%), 110 (55%), and 33 (16%) were classified as Coughlin grades 2, 3, and 4, respectively. There was no correlation between grade and active peak dorsiflexion (-0.069, P = .327) or VAS pain (-0.078, P = .271). Rank correlations between grade and cartilage loss were significant, but correlations were small. When stratified by grade, composite success rates between the 2 treatments were nearly identical. CONCLUSIONS: Irrespective of the grade, positive outcomes were demonstrated for both fusion and synthetic cartilage implant. Clinical symptoms and signs should be used to guide treatment, rather than a grade consisting of radiographic, symptoms, and range of motion factors. LEVEL OF EVIDENCE: Level II, randomized clinical trial.

Association Between Patient Factors and Outcome of Synthetic Cartilage Implant Hemiarthroplasty vs First Metatarsophalangeal Joint Arthrodesis in Advanced Hallux Rigidus.

BACKGROUND: We evaluated data from a clinical trial of first metatarsophalangeal joint (MTPJ1) implant hemiarthroplasty and arthrodesis to determine the association between patient factors and clinical outcomes. METHODS: Patients ≥18 years with hallux rigidus grade 2, 3, or 4 were treated with synthetic cartilage implant MTPJ1 hemiarthroplasty or arthrodesis. Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) sports and activities of daily living (ADL) scores, and Short Form-36 Physical Function (SF-36 PF) subscore were obtained preoperatively, and at 2, 6, 12, 24, 52, and 104 weeks postoperatively. Final outcome data, great toe active dorsiflexion motion, secondary procedures, radiographs, and safety parameters were evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. The composite primary endpoint criteria for clinical success included VAS pain reduction ≥30%, maintenance/improvement in function, no radiographic complications, and no secondary surgical intervention at 24 months. Predictor variables included hallux rigidus grade; gender; age; body mass index (BMI); symptom duration; prior MTPJ1 surgery; preoperative hallux valgus angle, range of motion (ROM), and pain. Two-sided Fisher exact test was used ( P < .05). RESULTS: Patient demographics and baseline outcome measures were similar. Success rates between implant MTPJ1 hemiarthroplasty and arthrodesis were similar ( P > .05) when stratified by hallux rigidus grade, gender, age, BMI, symptom duration, prior MTPJ1 surgery status, and preoperative VAS pain, hallux valgus, and ROM. CONCLUSION: Synthetic cartilage implant hemiarthroplasty was appropriate for patients with grade 2, 3, or 4 hallux rigidus. Its results in those with associated mild hallux valgus (≤20 degrees) or substantial preoperative stiffness were equivalent to MTPJ1 fusion, irrespective of gender, age, BMI, hallux rigidus grade, preoperative pain or symptom duration. LEVEL OF EVIDENCE: Level II, randomized clinical trial.

Outcome following use of the Achillon jig for the repair of acutely ruptured Achilles tendons.

We report a series of 143 patients who underwent limited open Achilles tendon repair using the Achillon device at a mean follow-up of 25 months. All patients attending our institution with a diagnosis of acute Achilles tendon rupture were considered for operative repair using the Achillon jig unless they declined surgery or met the exclusion criteria. Following surgery patients were contacted and asked to complete an Achilles Tendon Rupture Score (ATRS). The clinical records were reviewed for evidence of complications, demographic information and evidence of re-rupture. Statistical analysis of subgroups including age at presentation, delay to surgery and patients with complications was carried out using the Kruskal Wallis non-parametric test. We report no re-ruptures at a mean of 25 months (minimum 12 months) following surgery. The mean ATRS score was 84/100 (range 15-100). There was no statistical significance between any of the subgroups analyzed. In conclusion, acute Achilles repair using the Achillon jig is safe, with a low re-rupture rate, excellent ATRS scores at a minimum of 12 months post-operatively and low complications. The incidence of sural nerve injury is much lower than published series of percutaneous Achilles tendon repair without the use of a jig.

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

BACKGROUND: Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. METHODS: In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were nonrandomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. RESULTS: VAS pain scores decreased significantly in both the implant and arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6.2 degrees (27.3%) after implant placement and was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2%) implant patients (17 procedures) and 6 (12.0%) arthrodesis patients (7 procedures). Fourteen (9.2%) implants were removed and converted to arthrodesis, and 6 (12.0%) arthrodesis patients (7 procedures [14%]) had isolated screws or plate and screw removal. There were no cases of implant fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical equivalence between the implant and arthrodesis groups. CONCLUSION: A prospective, randomized (2:1), controlled, noninferiority clinical trial was performed to compare the safety and efficacy of a small synthetic cartilage bone implant to first MTP arthrodesis in patients with advanced-stage hallux rigidus. This study showed equivalent pain relief and functional outcomes. The synthetic implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP motion. The percentage of secondary surgical procedures was similar between groups. Less than 10% of the implant group required revision to arthrodesis at 2 years. LEVEL OF EVIDENCE: Level I, prospective randomized study.