Total Ankle Replacement Versus Arthrodesis Trial

Study Overview
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Brief Summary
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The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle osteoarthritis, and compare cost-effectiveness of the two treatments

Detailed Description
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This is a randomised, multi-centre, non-blinded, prospective, parallel-group trial of TAR versus ankle arthrodesis in patients with end-stage ankle osteoarthritis (OA) aged between 50 and 85 years, comparing clinical outcomes (pain-free function, quality of life (QoL), range of motion (ROM), and rate of post-procedural complications) and cost-effectiveness. TARVA is a clinician-led, pragmatic, superiority trial designed to compare the improvement in pain-free function, as assessed by the Manchester-Oxford Foot Questionnaire (MOXFQ) walking/standing domain score from pre-op to 52 weeks post-op for each surgical treatment group. A total of 328 patients will be randomly allocated on an equal basis to one of two surgical treatments: i) Total Ankle Replacement; and ii) Ankle Arthrodesis. Randomisation will be stratified by surgeon and presence of OA in two adjacent joints as determined by a pre-operative MRI scan.

Official Title
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A Randomised, Multi-centre, Non-blinded, Prospective, Parallel Group Trial of Total Ankle Replacement (TAR) Versus Ankle Arthrodesis in Patients With End Stage Ankle Osteoarthritis, Comparing Clinical Outcomes and Cost-effectiveness.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Total Ankle Replacement
* Procedure: Arthrodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of end-stage ankle osteoarthritis Aged 50-85 years inclusive The surgeon believes the patient is suitable for both TAR and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status) The patient is able to read and understand the Patient Information Sheet (PIS) and trial procedures The patient is willing and able to provide written informed consent Exclusion Criteria: Previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure More than 4 lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions) • Unable to have MRI/CT scan (e.g. severe claustrophobia or contraindication for either scan) History of local bone or joint infection Any co-morbidity, which, in the opinion of the investigator, is severe enough to; interfere with the patient's ability to complete the study assessments or; presents an unacceptable risk to the patient's safety Participant in another clinical trial that would materially impact on their participation in this study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthrodesis<br>Ankle arthrodesis (fusion) | Procedure: Arthrodesis<br>* The remaining damaged cartilage is removed from the ends of the bone and the two bones are then held together in compression using screws, or plates until they join to become one (bone fusion), so that there is no longer any movement at that joint.<br>* Other names: Fusion;|
| Experimental: Total Ankle Replacement<br>Total Ankle Replacement | Procedure: Total Ankle Replacement<br>* The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported pain-free function domain score | To compare the improvement in self-reported pain-free function domain score from pre-op to 52 weeks post-op for TAR versus arthrodesis, assessed by MOXFQ walking/standing domain scores. | Pre-operation (baseline) to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported pain-free function domain score | To compare the improvement in self-reported pain-free function domain score from pre-op to 26 weeks post-op for TAR versus arthrodesis, assessed by MOXFQ walking/standing domain scores. | Pre-operation (baseline) to 26 weeks | 
| Self-reported pain and social interaction domain score | To compare the improvement in self-reported pain and social interaction domain scores from pre-op to 26 and 52 weeks post-op for TAR versus arthrodesis, assessed by MOXFQ. | Pre-operation (baseline) to 26 and 52 weeks | 
| Self-reported physical function | To compare the improvement in self-reported physical function from pre-op to 26 and 52 weeks post-op of TAR versus arthrodesis, assessed by the Foot and Ankle Ability Measure (FAAM) questionnaire. | Pre-operation (baseline) to 26 and 52 weeks | 
| Self-reported quality of life | To compare the improvement in QoL from pre-op to 26 and 52 weeks post-op of TAR versus arthrodesis, assessed by EQ-5D. | Pre-operation (baseline) to 26 and 52 weeks | 
| Range of Motion | To compare the change in total ROM (plantarflexion and dorsiflexion) from pre-op to 52 weeks post-op of TAR versus arthrodesis, assessed by goniometer. | Pre-operation (baseline) to 52 weeks | 
| Adverse events | To compare the safety of TAR versus arthrodesis in terms of complications and adverse events. | 52 weeks | 
| Incremental cost and cost-effectiveness | To compare the incremental cost and cost-effectiveness of TAR versus arthrodesis by recording cost of all components and procedure-related costs for each surgical treatment, and using self-reported data from the Health and Social Care Services Use questionnaire. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle arthritis, osteoarthritis, total ankle replacement, arthrodesis, quality of life, musculoskeletal