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Category: Ankle Arthritis; Ankle; Hindfoot; Other Introduction/Purpose: End-stage ankle osteoarthritis (EOA) causes severe pain and chronic disability. Once non operative measures have been exhausted the two main surgical treatments include total ankle replacement (TAR) and ankle fusion (AF). Systematic reviews have confirmed that both procedures are effective but there has never been a robust randomised multicentre level I study comparing the two treatments. Our objective was to investigate and compare the clinical and cost effectiveness of TAR against AF in the treatment of end-stage ankle osteoarthritis in patients aged 50-85 years. Methods: TARVA is a multi-centre, parallel-group, open label randomised trial. Patients with EOA, aged 50-85, suitable for either procedure were recruited at 17 UK hospitals. Randomisation was carried out using a secure on-line service and was stratified by surgeon and the presence or absence of adjacent joint OA (based on an independently reviewed preoperative MRI scan). Participants were randomised 1:1 to either TAR or ankle arthrodesis. The primary outcome was the change in the Manchester Oxford Foot & Ankle Questionnaire (MOXFQ) walking/standing domain scores between pre-operation and 52 weeks post- operation. Secondary outcomes measures included FAAM; FAAM (ADL); and Sport subscale scores. Quality of life was measured using the EQ-5D-5L. Total range of tibia to floor motion was measured using a validated method. Health economic analysis used mean incremental cost per quality-adjusted life years (QALY) gained. Analysis was by intention to treat. The trial registration is ISRCTN60672307. Results: Of 933 eligible patients 303 were randomised. 282 underwent surgery. Mean age 68 (71% male). Aetiology was post- trauma in 55.3%, and inflammatory in 7.1%. Groups were well balanced at baseline on all parameters. 54% TARs were fixed bearing. 61% of fusions were performed arthroscopically. At 2 years the adjusted mean difference in the change in MOXFQ W/S between TAR & AF was -4.4(95% CI -11.38 to 2.68, p=0∙23). Post hoc analysis of the commonest implant type (fixed bearing TAR) did show a statistically significant improvement over AF (p=0∙04, -8.9, 95% CI -17.2 to -0.6). Secondary outcomes, EQ5D-VAS and FAAM were significant. Complications included wound healing issues (13.8% vs 5.5%); nerve injuries (4.3% vs 0.7%). 11.8% of AF patients had plain radiographic evidence of non-union but only 6.9% had symptoms. Reoperation rate was 7.2% for TAR vs 5.2% for AF; and revision rate was 0.7% for TAR vs 2.8% for AF. Conclusion: Patients improved in all outcomes in both arms. We did not show a significant difference in our primary outcome measure between TAR and AF overall(p=0.23), but did show significance when fixed bearing TAR alone was compared against AF(p=0.04). Secondary outcomes did show significance. Adjacent joint arthritis increases the size of effect noted between arms. There were more wound healing issues and nerve injuries in TAR group. The symptomatic non-union rate for AF is 6.9%. TAR is likely to be cost-effective compared to AF at the NICE cost-effectiveness threshold of £20,000 per Quality Adjusted Life Year gained over the patients' lifetime.

Category: Ankle Arthritis; Ankle; Other Introduction/Purpose: Both ankle replacement and ankle arthrodesis are offered as treatments to patients with end stage ankle osteoarthritis. Systematic reviews have confirmed that both procedures are effective but there has never been a robust randomised multicentre level I study comparing the two treatments. Our objective was to investigate and compare the clinical and cost effectiveness and complication rates of ankle replacement against ankle arthrodesis in the treatment of end-stage ankle osteoarthritis in patients aged 50-85 years. Methods: 17 NHS centres and 35 surgeons across the United Kingdom participated. Formal Ethics committee approvals were obtained. A Trial Management Group was overseen by a Trial Steering Committee, and an Independent Data Monitoring Committee. Randomisation was carried out using a secure on-line service and was stratified by surgeon and the presence or absence of adjacent joint OA (based on an independently reviewed preoperative MRI scan). Participants were randomised 1:1 to either TAR or ankle fusion. The primary outcome was the change in the Manchester Oxford Foot & Ankle Questionnaire (MOXFQ) walking/standing domain scores between pre-operation and 52 weeks post-operation. Secondary outcomes measures included FAAM; FAAM (ADL); and Sport subscale scores. Quality of life was measured using the EQ-5D-5L. Total range of motion was measured using a validated method. Radiological parameters and adverse events were captured. Health economic analysis used mean incremental cost per quality-adjusted life years (QALY) gained. Results: 1600 patients were screened for eligibility. 330 participants were consented and 303 were randomised; 282 underwent surgery and attended follow-up visits. Mean age was 68 years (71% male). The aetiology of OA was post-trauma in 60%, with 6% patients having inflammatory OA. 42% had MRI evidence of OA in the adjacent joints. The groups were well balanced at baseline on all other parameters including deformity, range of motion and baseline clinical and quality of life scores.42% had MRI evidence of OA in the adjacent joints. 54% TARs used were fixed bearing; 46% were mobile bearing. 61% of fusions were performed arthroscopically. We present all outcomes including adverse effects (death; thromboembolic events; reoperation and revision); radiological findings; and range of motion. We also present subgroup analyses looking at the performance of fixed versus mobile bearing implants; differences by age; and by the presence or absence of adjacent joint OA. Conclusion: This is the first publicly funded, multicentre, prospective, randomised clinical trial comparing the clinical and cost effectiveness of ankle replacement against ankle fusion. It is also the first study in surgery to have detailed prospectively captured health economic data to be able to feed into the reimbursement discussions on these life transforming treatments. Due to contractual requirements of the funders the formal results cannot be released until the final report has been submitted for peer review which will not happen until the end of April 2021. The paper is submitted on behalf of the TARVA Study Group.

Category: Other Introduction/Purpose: Surgical repair of symptomatic chronic Achilles tendon (TA) rupture is a challenging problem due to the presence of large defect between tendon edges. We report the results of surgical repair of symptomatic chronic TA rupture by synthetic graft augmentation. Methods: Seven consecutive patients with a symptomatic chronic TA rupture underwent surgical repair by VY plasty and augmentation with bio-absorbable synthetic graft (Artelon®). In all patients, the intraoperative tendon gap after debridement was more than 5 cm (Myerson Grade 3). Postoperatively, weight bearing on plantigrade foot was allowed at 4 weeks in a plaster cast. The total duration of plaster immobilization was 10 weeks. The complications were recorded prospectively and functional outcome was assessed by AOFAS score and Achilles tendon Total Rupture Score (ATRS). Results: At a mean follow up of 29 months there was no re-rupture or deep infection. All patients reported good functional outcome as shown by AOFAS and ATRS scores. There were no graft related complications. One patient had an early superficial infection which was treated by a course of oral antibiotic. Two patients reported numbness in the sural nerve territory after surgery,of which one patient developed scar sensitivity and paraesthesia. At final follow up, six patients were able to do single stance heel raise however, calf wasting was noted in all patients. Conclusion: Symptomatic chronic TA repair augmented by synthetic graft is a safe and effective technique in Myerson Grade 3 chronic TA ruptures where gap between two tendon edges is more than 5 cm.