Total Ankle Replacement Versus Arthrodesis Trial

N/AActive Not RecruitingNCT02128555

University College, London303 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

303

Conditions

Osteoarthritis

Interventions

Total Ankle ReplacementPROCEDURE

The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.

ArthrodesisPROCEDURE

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (17)

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, United Kingdom

Brighton & Sussex University Hospitals NHS Trust

Brighton, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Pre-operation (baseline) to 52 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Pre-operation (baseline) to 52 weeks

Data from ClinicalTrials.gov

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