Dataset Information

A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan.

ABSTRACT:

Background

The total ankle replacement versus ankle arthrodesis (TARVA) trial aims to determine which surgical procedure confers the greatest improvement in pain-free function for patients with end-stage ankle osteoarthritis. Both procedures are effective but there has not yet been a direct comparison to establish which is superior. This article describes the statistical analysis plan for this trial as an update to the published protocol. It is written prior to the end of patient follow-up, while the outcome of the trial is still unknown.

Design and methods

TARVA is a randomised, un-blinded, parallel group trial of total ankle replacement versus ankle arthrodesis. The primary outcome is the Manchester-Oxford Foot Questionnaire walking/standing domain score at 52?weeks post-surgery. Secondary outcomes include measures of pain, social interaction, physical function, quality of life, and range of motion. We describe in detail the statistical aspects of TARVA: the outcome measures, the sample size calculation, general analysis principles including treatment of missing data, the planned descriptive statistics and statistical models, and planned subgroup and sensitivity analyses.

Discussion

The TARVA statistical analysis will provide comprehensive and precise information on the relative effectiveness of the two treatments. The plan will be implemented in January 2020 when follow-up for the trial is completed.

Trial registration

ISRCTN registry number 60672307, ClinicalTrials.gov registration number NCT02128555. Registered 1 May 2014. Recruitment started in January 2015 and ended in January 2019.

SUBMITTER: Muller P

PROVIDER: S-EPMC7029552 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan.

Muller Patrick P Skene Simon S SS Chowdhury Kashfia K Cro Suzie S Goldberg Andrew J AJ Doré Caroline J CJ

Trials 20200218 1

<h4>Background</h4>The total ankle replacement versus ankle arthrodesis (TARVA) trial aims to determine which surgical procedure confers the greatest improvement in pain-free function for patients with end-stage ankle osteoarthritis. Both procedures are effective but there has not yet been a direct comparison to establish which is superior. This article describes the statistical analysis plan for this trial as an update to the published protocol. It is written prior to the end of patient follow- ...[more]

PMID: 32070409

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Project description:BackgroundPatients 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).ObjectivesOur 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.MethodWe 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.ResultsTotal 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.ConclusionTAR 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.

Project description:BackgroundAnkle replacement and ankle arthrodesis are standard treatments for treating end-stage ankle arthritis when conservative treatment fails. Comparing patient-reported outcome scores to the instrument's minimal important difference (MID) helps physicians and researchers infer whether a meaningful change in health from the patient's perspective has occurred following treatment. The objective of this study was to estimate the MID of the Ankle Osteoarthritis Scale among a cohort of operatively treated end-stage ankle arthritis patients undergoing ankle replacement or arthrodesis.MethodsA survey package including the Ankle Osteoarthritis Scale was completed by participants preoperatively and 2 years postoperatively. Distribution and anchor-based approaches to calculating the MID were used to estimate the MID of the Ankle Osteoarthritis Scale and its 2 domains. The distribution-based approaches used were the small and medium effect size methods, while the mean absolute change method and linear regression method were the anchor-based approaches. Bootstrap sampling was used to obtain the variance of MID estimates. The MID was estimated for sex, age, operative, and baseline health subgroups. The cohort comprised 283 participants, totaling 298 ankles.ResultsThe MID did not vary with sex or operative procedure. Age-based differences in MID values may exist for the Ankle Osteoarthritis Scale total score, and MID values were generally smallest among the oldest patients. Patients with the best and worst ankle-related health preoperatively had higher MID values than patients reporting mid-range Ankle Osteoarthritis Scale values preoperatively.ConclusionThe best estimate of the MID of the Ankle Osteoarthritis Scale total score is 5.81. Our findings indicate that the MID of the Ankle Osteoarthritis Scale may not vary by sex or operative subgroups but likely varies by age and preoperative Ankle Osteoarthritis Scale score.Level of evidenceLevel II, prospective comparative study.

Project description:BackgroundTreatment of ankle fractures in patients with diabetes is associated with increased complication rates. Ankle arthrodesis is considered a salvage procedure after failed ankle fracture fixation, yet primary ankle arthrodesis has been proposed as a treatment option for patients with significant diabetes-related complications. To date, the characteristics of patients who undergo primary ankle arthrodesis and the associated outcomes have not been described.MethodsA retrospective review was performed of 13 patients with diabetes who underwent primary arthrodesis for traumatic ankle fracture. Patient demographics were characterized in addition to their diabetes complications, Adelaide Fracture in the Diabetic Ankle (AFDA) score, and fracture type. Outcomes assessed included reoperation rates, infection rates, wound complications, nonunion/malunion, amputation, and development of Charcot arthropathy postoperatively.ResultsPatients who underwent primary arthrodesis had high rates of diabetes complications, average AFDA scores of 6.4, and high rates of severe injuries, including 38.5% open fractures and 69.2% fracture dislocations. The overall complication rate for primary arthrodesis of ankle fractures in diabetes patients was more than 75% in this cohort. Complications included a 38.5% reoperation rate, 38.5% infection rate, 53.8% wound complication rate, and 23.1% amputation rate. Despite a high nonunion rate at the attempted fusion sites, 89.9% of fractures healed and patients had a stable extremity.ConclusionThis review is the first to characterize the epidemiology and complications of diabetes patients undergoing primary ankle arthrodesis for ankle fractures. In this cohort, patients with multiple diabetic complications and severe injuries underwent primary arthrodesis, which led to an overall high complication rate. Further research is needed to determine the appropriate treatment option for these high-risk patients, and tibiotalocalcaneal stabilization without arthrodesis may be beneficial.Level of evidenceLevel IV, retrospective case series.

Project description:BackgroundTotal ankle replacement (TAR) utilization in the United States has steeply increased in recent decades. Emergency department (ED) visits following TAR impacts patient satisfaction and health care costs and warrant exploration.MethodsThis retrospective cohort study utilized the 2010 to 2019 M91Ortho PearlDiver data set to identify TAR patients with at least 90 days of follow-up. PearlDiver contains billing claims data across all sites of care throughout the United States for all indications for care. Patient factors extracted included age, sex, Elixhauser Comorbidity Index (ECI), region of the country in which surgery was performed, insurance plan, and postoperative hospital length of stay. Ninety-day postoperative ED visit incidence, timing, frequency, and primary diagnoses were identified and compared to 1-year postoperative ED visit baseline data. Univariate and multivariate logistic regression analyses were used to determine risk factors for ED visits.ResultsOf 5930 TAR patients identified, ED visits within 90 days were noted for 497 (8.4%) patients. Of all ED visits, 32.0% occurred within 2 weeks following surgery. Multivariate analysis revealed several predictors of ED utilization: younger age (odds ratio [OR] 1.35 per decade decrease), female sex (OR 1.20), higher ECI (OR 1.32 per 2-point increase), TAR performed in the western US (OR 1.34), and Medicaid coverage (OR 2.70; 1.71-4.22 relative to Medicare) (P < .05 each). Surgical site issues comprised 78.0% of ED visits, with surgical site pain (57.0%) as the most common problem.ConclusionOf 5930 TAR patients, 8.4% returned to the ED within 90 days of surgery, with predisposing demographic factors identified. The highest incidence of ED visits was in the first 2 postoperative weeks, and surgical site pain was the most common reason. Pain management pathways following TAR should be able to be adjusted to minimize the occurrence of postoperative ED visits, thereby improving patient experiences and decreasing health care utilization/costs.Level of evidenceLevel III, retrospective cohort study.

Project description:BackgroundThis study aimed to clarify the clinical outcomes of surgical treatment for end-stage ankle osteoarthritis in patients aged ≥ 75 years and compare these outcomes with those of patients aged < 75 years.MethodsA total of 148 patients, including 65 who underwent total ankle arthroplasty and 83 who underwent ankle arthrodesis, were retrospectively surveyed. Clinical outcomes were assessed preoperatively and at the last follow-up using the Japanese Society for Surgery of the Foot Hindfoot Scale and a self-administered foot evaluation questionnaire (SAFE-Q). Patient characteristics, including age, sex, body mass index, radiographic severity, and follow-up period, were also assessed. The patients were divided into older (≥ 75 years) and younger (< 75 years) age groups. Improvements in outcomes were then compared between age groups using univariate analysis and analysis of covariance adjusted for patient characteristics. Total ankle arthroplasty and ankle arthrodesis were analyzed separately.ResultsAll clinical outcome scores improved postoperatively in the older age groups for both procedures. Scores for the pain and pain-related subscale of the SAFE-Q improved by 37 points (p < 0.001) in post-total ankle arthroplasty patients and by 35 points in post-ankle arthrodesis patients (p < 0.001). Furthermore, multivariate analysis showed that the improvements observed in all scores were not different between the older and younger age groups for both post-total ankle arthroplasty and post-ankle arthrodesis patients, except for the SAFE-Q physical functioning subscale score for post-ankle arthrodesis patients. The clinical outcomes improved significantly in post-total ankle arthroplasty and post-ankle arthrodesis patients aged ≥ 75 years. Moreover, these improvements were similar to those observed in patients aged < 75 years.ConclusionsSurgical treatment of end-stage ankle osteoarthritis can be a viable treatment option, even in elderly patients, and can be expected to improve similarly to younger patients.

Project description:BackgroundEnd-stage ankle osteoarthritis typically causes severe pain and impaired function. Surgical treatment involves total ankle replacement (TAR) or ankle fusion. Definitive evidence about which procedure is optimal is lacking. No previous studies have thoroughly explored patients' experiences across the entire TAR/ankle fusion pathway. This study aimed to address this gap by exploring perceptions of surgery, education, rehabilitation and outcomes among patients who had undergone TAR or ankle fusion.MethodsSeven participants were purposively selected from an orthopaedic centre in northern England (3 females, 4 males). Participants had undergone primary TAR without revision (n = 2), TAR requiring revision (n = 3) or ankle fusion (n = 2). Each participant completed a single semi-structured interview. Interviews were digitally recorded, transcribed verbatim and analysed thematically.ResultsThree themes, each with two subthemes, were identified: decision-making (seeking help; surgical options), perceptions of support (information/education; clinical support) and impact on the individual (personal circumstances and beliefs; post-operative outcomes). Pain affecting participants' valued activities was key to their decision to seek help. Participants' decision between TAR and ankle fusion was influenced by multiple factors. Concerns regarding the lack of joint flexibility following fusion were highlighted, with some participants perceiving TAR as a "proper ankle" that would enable them to avoid limping. Participants obtained information from various sources, with most feeling that the education from their care team was inadequate. Participants' individual circumstances and beliefs influenced their decision-making and perceptions of their post-operative outcomes. Finally, whilst most participants were pleased with their outcomes, some experienced substantial ongoing problems such as difficulty walking and chronic pain.ConclusionsThis study demonstrates the importance of providing adequate education about TAR and ankle fusion to enable patients to make informed decisions. Most participants felt that the education and clinical support they received did not fully meet their needs. Participants' personal circumstances and beliefs had a strong influence on their decision-making and perceptions of their post-operative outcomes, highlighting the need to personally tailor education and clinical support. Future work with a larger sample of patients and other key stakeholders is required to develop consensus-based guidelines on pre- and post-operative support for patients undergoing TAR/ankle fusion.

Dataset Information

A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan.

Background

Design and methods

Discussion

Trial registration

Publications

A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan.

Similar Datasets

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