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NCT Number: NCT02128555

Total Ankle Replacement Versus Arthrodesis Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis Ankylosis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Cornwall Hospitals NHS Trust, Truro, Cornwall, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total ankle replacement

Procedure

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

Arthrodesis

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Adverse events

    Time frame: 52 weeks

    To compare the safety of TAR versus arthrodesis in terms of complications and adverse events.

  7. 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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study 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.

Acronym: TARVA

Important dates

Study start
2015
Primary completion
2019
Study completion
2029
First posted
May 1, 2014
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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