Total Ankle Replacement Versus Arthrodesis Trial
- Conditions
- Osteoarthritis
- Interventions
- Procedure: Total Ankle ReplacementProcedure: Arthrodesis
- Registration Number
- NCT02128555
- Lead Sponsor
- University College, London
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 303
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Total Ankle Replacement Total Ankle Replacement Total Ankle Replacement Arthrodesis Arthrodesis Ankle arthrodesis (fusion)
- Primary Outcome Measures
Name Time Method Self-reported pain-free function domain score 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 Outcome Measures
Name Time Method Incremental cost and cost-effectiveness 52 weeks 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.
Self-reported pain and social interaction domain score Pre-operation (baseline) to 26 and 52 weeks 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.
Self-reported physical function Pre-operation (baseline) to 26 and 52 weeks 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.
Self-reported pain-free function domain score Pre-operation (baseline) to 26 weeks 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.
Self-reported quality of life Pre-operation (baseline) to 26 and 52 weeks To compare the improvement in QoL from pre-op to 26 and 52 weeks post-op of TAR versus arthrodesis, assessed by EQ-5D.
Range of Motion Pre-operation (baseline) to 52 weeks 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.
Adverse events 52 weeks To compare the safety of TAR versus arthrodesis in terms of complications and adverse events.
Trial Locations
- Locations (17)
Brighton & Sussex University Hospitals NHS Trust
🇬🇧Brighton, United Kingdom
Cardiff and Vale Orthopaedic Centre
🇬🇧Cardiff, United Kingdom
North Bristol NHS Trust
🇬🇧Bristol, United Kingdom
Royal Derby Hospital
🇬🇧Derby, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
🇬🇧Hull, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
🇬🇧Norwich, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Robert Jones & Agnes Hunt Orthopaedic Hospital
🇬🇧Oswestry, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
Royal National Orthopaedic Hospital NHS Trust
🇬🇧Stanmore, United Kingdom
Wrightington Hospital
🇬🇧Wigan, United Kingdom
Royal Cornwall Hospitals NHS Trust
🇬🇧Truro, Cornwall, United Kingdom
Northumbria Healthcare NHS Foundation Trust
🇬🇧Newcastle, United Kingdom