Total Ankle Replacement Versus Arthrodesis Trial (TARVA)

March 12, 2021 updated by: University College, London

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.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Brighton, United Kingdom
        • Brighton & Sussex University Hospitals NHS Trust
      • Bristol, United Kingdom
        • North Bristol NHS Trust
      • Cardiff, United Kingdom
        • Cardiff and Vale Orthopaedic Centre
      • Derby, United Kingdom, DE22 3NE
        • Royal Derby Hospital
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Hull, United Kingdom
        • Hull and East Yorkshire Hospitals NHS Trust
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospital
      • Newcastle, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Newcastle, United Kingdom
        • Northumbria Healthcare NHS Foundation Trust
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospitals Nhs Foundation Trust
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust
      • Oswestry, United Kingdom, SY10 7AG
        • Robert Jones & Agnes Hunt Orthopaedic Hospital
      • Oxford, United Kingdom, OX3 7LD
        • Oxford University Hospitals NHS Foundation Trust
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
      • Stanmore, United Kingdom, HA7 4LP
        • Royal National Orthopaedic Hospital NHS Trust
      • Wigan, United Kingdom, WN6 9EP
        • Wrightington Hospital
    • Cornwall
      • Truro, Cornwall, United Kingdom, tr1 3lq
        • Royal Cornwall Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arthrodesis
Ankle arthrodesis (fusion)
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.
Other Names:
  • Fusion
Experimental: Total Ankle Replacement
Procedure: Total Ankle Replacement
The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported pain-free function domain score
Time Frame: 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.
Pre-operation (baseline) to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported pain-free function domain score
Time Frame: 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.
Pre-operation (baseline) to 26 weeks
Self-reported pain and social interaction domain score
Time Frame: 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.
Pre-operation (baseline) to 26 and 52 weeks
Self-reported physical function
Time Frame: 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.
Pre-operation (baseline) to 26 and 52 weeks
Self-reported quality of life
Time Frame: 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.
Pre-operation (baseline) to 26 and 52 weeks
Range of Motion
Time Frame: 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.
Pre-operation (baseline) to 52 weeks
Adverse events
Time Frame: 52 weeks
To compare the safety of TAR versus arthrodesis in terms of complications and adverse events.
52 weeks
Incremental cost and cost-effectiveness
Time Frame: 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.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Andrew Goldberg, Royal National Orthopaedic Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 23, 2019

Study Completion (Anticipated)

February 28, 2029

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/0518
  • 12/35/27 (Other Grant/Funding Number: NIHR HTA)
  • ISRCTN60672307 (Registry Identifier: ISRCTN)
  • U1111-1157-4155 (Registry Identifier: Universal Trial Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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