Trials / Active Not Recruiting

Active Not RecruitingNCT02128555

Total Ankle Replacement Versus Arthrodesis Trial

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.

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 303 (actual)

Sponsor: University College, London · Academic / Other
Sex: All
Age: 50 Years – 85 Years
Healthy volunteers: Accepted

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.

Conditions

Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Total Ankle Replacement	The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.
PROCEDURE	Arthrodesis	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.

Timeline

Start date: 2015-01-01
Primary completion: 2019-12-23
Completion: 2029-02-28
First posted: 2014-05-01
Last updated: 2021-03-15

Locations

17 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02128555. Inclusion in this directory is not an endorsement.