Total Ankle Replacement Versus Arthrodesis Trial

Osteoarthritis Clinical Trial

— TARVA  

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02128555
• Other study ID #: 12/0518
• Secondary ID: 12/35/27ISRCTN60
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: February 28, 2029

Study information

• Verified date: March 2021
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT01518361

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 303
• Est. completion date: February 28, 2029
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Total Ankle Replacement
The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.
• 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.

Locations

Country	Name	City	State
United Kingdom	Brighton & Sussex University Hospitals NHS Trust	Brighton
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Cardiff and Vale Orthopaedic Centre	Cardiff
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	Aintree University Hospital	Liverpool
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Newcastle
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	Royal Cornwall Hospitals NHS Trust	Truro	Cornwall
United Kingdom	Wrightington Hospital	Wigan

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-operation (baseline) to 52 weeks
Secondary	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.	Pre-operation (baseline) to 26 weeks
Secondary	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.	Pre-operation (baseline) to 26 and 52 weeks
Secondary	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.	Pre-operation (baseline) to 26 and 52 weeks
Secondary	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.	Pre-operation (baseline) to 26 and 52 weeks
Secondary	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.	Pre-operation (baseline) to 52 weeks
Secondary	Adverse events	To compare the safety of TAR versus arthrodesis in terms of complications and adverse events.	52 weeks
Secondary	Incremental cost and cost-effectiveness	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.	52 weeks

External Links

•   TARVA website