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.

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.

Osteochondral Lesions of the Ankle Treated with Bone Marrow Concentrate with Hyaluronan and Fibrin: A Single-Centre Study.

Osteochondral defects of the ankle (OCD) are being increasingly identified as a clinically significant consequence of injury to the ankle, with the potential to lead to osteoarthritis if left untreated. The aim of this retrospective cohort study was to evaluate a single-stage treatment of OCD, based on bone marrow aspirate (BMA) centrifuged to produce bone marrow concentrate (BMC). In a dual syringe, the concentrate was mixed with thrombin in one syringe, whereas hyaluronan and fibrinogen were mixed in a second syringe. The two mixtures were then injected and combined into the prepared defect. Clinical outcome and quality of life scores (MOXFQ and EQ-5D) were collected at baseline and yearly thereafter. Multilevel models were used to analyse the pattern of scores over time. Ninety-four patients were treated between 2015 and 2020. The means of each of the three components of the MOXFQ significantly improved between baseline and 1 year (p < 0.001 for each component), with no further change from year 1 to year 3. The EQ-5D index also improved significantly from baseline to 1 year, with no evidence for further change. Our results strongly indicate that this BMC treatment is safe for, and well tolerated by, patients with OCD of the ankle as both primary treatment and those who have failed primary treatment. This technique provides a safe, efficacious alternative to currently employed cartilage repair techniques, with favourable outcomes and a low complication rate at 36 months.

Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis : a qualitative study.

AIMS: A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. METHODS: We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. RESULTS: Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. CONCLUSION: This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators' meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631-637.

Early experience and patient-reported outcomes of 503 INFINITY total ankle arthroplasties.

AIMS: This is a multicentre, non-inventor, prospective observational study of 503 INFINITY fixed bearing total ankle arthroplasties (TAAs). We report our early experience, complications, and radiological and functional outcomes. METHODS: Patients were recruited from 11 specialist centres between June 2016 and November 2019. Demographic, radiological, and functional outcome data (Ankle Osteoarthritis Scale, Manchester Oxford Questionnaire, and EuroQol five-dimension five-level score) were collected preoperatively, at six months, one year, and two years. The Canadian Orthopaedic Foot and Ankle Society (COFAS) grading system was used to stratify deformity. Early and late complications and reoperations were recorded as adverse events. Radiographs were assessed for lucencies, cysts, and/or subsidence. RESULTS: In all, 500 patients reached six-month follow-up, 420 reached one-year follow-up, and 188 reached two-year follow-up. The mean age was 67.8 years (23.9 to 88.5). A total of 38 patients (7.5%) presented with inflammatory arthritis. A total of 101 (20.0%) of implantations used patient-specific instrumentation; 167 patients (33.1%) underwent an additional procedure at the time of surgery. A total of seven patients died of unrelated causes, two withdrew, and one was lost to follow-up. The mean follow-up was 16.2 months (6 to 36). There was a significant improvement from baseline across all functional outcome scores at six months, one, and two years. There was no significant difference in outcomes with the use of patient-specific instrumentation, type of arthritis, or COFAS type. Five (1.0%) implants were revised. The overall complication rate was 8.8%. The non-revision reoperation rate was 1.4%. The 30-day readmission rate was 1.2% and the one-year mortality 0.74%. CONCLUSION: The early experience and complications reported in this study support the current use of the INFINITY TAA as a safe and effective implant in the treatment of end-stage ankle arthritis. Cite this article: Bone Joint J 2021;103-B(7):1270-1276.

Design and psychometric testing of a new patient-reported outcome measure for ankle treatment.

BACKGROUND: Several outcome scores are used to assess the outcome of ankle surgery, but many are not validated and there is currently no 'gold-standard'. Consequently, there is demand to develop a new 'gold-standard' score to assess ankle surgery. The study aim was to review existing scores to develop and validate a new patient-reported outcome measure (PROM) to assess the outcome of operative ankle surgery. METHODS: The questionnaire items covered three areas: pain, symptoms and activity. The scale was reviewed by a patient group, resulting in the Oswestry Ankle score (Os-Ankle). The Os-Ankle was validated using a cohort of 206 patients at both pre-operative and post-operative stages of ankle surgery. Patients provided two other outcome scores, the scores currently used at our centre: the Manchester-Oxford Foot Questionnaire (MOxFQ) and the Veterans Rand-12 (VR-12). Factor analysis and Rasch were determined to assess the psychometric testing and design of the Os-Ankle score. A follow up paper assesses the validity of the Os-Ankle against two existing scores. RESULTS: Results of the factor and Rasch analysis suggested that 12-items should be removed. The remaining 18-items fitted the Rasch model well, suggesting good internal consistency. CONCLUSION: A new ankle PROM, the Os-Ankle, was successfully developed and demonstrated good psychometric testing. The Os-Ankle evaluates pain, symptoms and activities and results in a single score. The Os-Ankle has been validated in our follow up paper, and is ready to be implemented by ankle clinicians to monitor clinical outcomes. With the publication of two back to back papers, it will allow for further engage with other clinicians and other centres. LEVEL OF EVIDENCE: Level II, prospective comparative study.

Should the Tibiotalar Angle Be Measured Using an AP or Mortise Radiograph? Does It Matter?

Understanding the tibiotalar angle (TTA) is key to planning for deformity correction. The TTA is an important radiographic tool to determine alignment or malalignment of the ankle and hindfoot. Two methods of measuring the TTA have been described: the midline TTA (MTTA) and the lateral TTA (LTTA). The aim of this study was to compare the 2 angles as measured on mortise and anteroposterior (AP) radiographs in a series of normal and pathological cases. A radiographic review was performed of sequential ankle AP and mortise radiographs taken between January 2016 and September 2017 across 4 specialist orthopedic centers. Patients were categorized into a normal group, where patients had normal radiological appearances, and an arthritis group, where patients had radiographic arthritis. The MTTA and the LTTA were measured. The overall mean ± standard deviation MTTA was 88.7° ± 5.1°, and mean LTTA was 87.5° ± 5.2° (p < .01). There was no statistically significant difference between the MTTA and LTTA in the normal group or on AP radiographs alone (p = .09). There was a statistically significant difference between the MTTA and LTTA in the arthritis group (p < .01) and when measured on mortise radiographs (p = .02). The MTTA had no difference when measured on the AP and mortise radiographs. There was a statistically significant difference in the LTTA between AP and mortise radiographs (p = .04). We have shown the MTTA to be a reliable and reproducible tool in all patients, on AP and mortise radiographs. The type of radiograph does not alter the measurement of deformity. In contrast, we have shown the LTTA to be unreliable and statistically different when measured on AP and mortise radiographs.

The success of tibiotalocalcaneal arthrodesis with intramedullary nailing--a systematic review of the literature.

Tibiotalocalcaneal arthrodesis with an intramedullary nail may find indications for a variety of conditions of the hindfoot. We performed a systematic review of the literature primarily to find out the union rates and complications of tibiotalocalcaneal arthrodesis with an intramedullary nail. We included 33 studies for this review. These studies included 631 patients who had 659 procedures. Eighteen cases were excluded and 641 joints (613 patients) were available for the final analysis. We analysed the indications, union rates, complications and re-operation rates. The union rate was 86.7% with an average union time of 4.5 months. The complication rate was 55.7%. Metalwork related complications made a significant proportion of all the complications. The re-operation rate was 22%. Revision arthrodesis was done in 3% and amputation in 1.5% the cases. The review indicates that tibiotalocalcaneal arthrodesis with an intramedullary nail has a relatively good union rate but a high rate of complications. Majority of the complications are related to the metalwork. The suggested strategies to minimise these complications are discussed.

No drain, autologous transfusion drain or suction drain? A randomised prospective study in total hip replacement surgery of 168 patients.

We performed a prospective, randomised controlled trial to assess the differences in the use of a conventional suction drain, an Autologous Blood Transfusion (ABT) drain and no drain, in 168 patients. There was no significant difference between the drainage from ABT drains ( mean : 345 ml) and the suction drain (314 ml). Forty percent of patients receiving a suction drain had a haemoglobin level less than 10 g/dL at 24 hours, compared to 35% with no drain and 28% with an ABT drain. Patients that had no drains had wounds that were dry significantly sooner, mean 3.0 days compared to a mean of 3.9 days with an ABT drain and a mean of 4 days with a suction drain. Patients that did not have a drain inserted stayed in hospital a significantly shorter period of time, compared with drains. We feel the benefits of quicker drying wounds, shorter hospital stays and the economic savings justify the conclusion that no drain is required after hip replacement.