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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 303
- 试验地点
- 27
- 主要终点
- Self-reported pain-free function domain score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Self-reported pain-free function domain score
时间窗: 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.
次要结局
- 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 quality of life(Pre-operation (baseline) to 26 and 52 weeks)
- Range of Motion(Pre-operation (baseline) to 52 weeks)
- Self-reported pain-free function domain score(Pre-operation (baseline) to 26 weeks)
- Adverse events(52 weeks)
- Incremental cost and cost-effectiveness(52 weeks)