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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University College, London
- Enrollment
- 303
- Locations
- 17
- Primary Endpoint
- Self-reported pain-free function domain score
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Arthrodesis
Ankle arthrodesis (fusion)
Intervention: Arthrodesis (Procedure)
Total Ankle Replacement
Total Ankle Replacement
Intervention: Total Ankle Replacement (Procedure)
Outcomes
Primary Outcomes
Self-reported pain-free function domain score
Time Frame: Pre-operation (baseline) to 52 weeks
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.
Secondary Outcomes
- Self-reported pain and social interaction domain score(Pre-operation (baseline) to 26 and 52 weeks)
- Self-reported physical function(Pre-operation (baseline) to 26 and 52 weeks)
- Self-reported pain-free function domain score(Pre-operation (baseline) to 26 weeks)
- Self-reported quality of life(Pre-operation (baseline) to 26 and 52 weeks)
- Range of Motion(Pre-operation (baseline) to 52 weeks)
- Adverse events(52 weeks)
- Incremental cost and cost-effectiveness(52 weeks)