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OsteoarthritisTARVANCT02128555

Total Ankle Replacement Versus Arthrodesis Trial

A study testing Total Ankle Replacement and Arthrodesis in people with Osteoarthritis, run by University College, London at 17 sites in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis
What is being tested?
Total Ankle Replacement and Arthrodesis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
17 sitesUnited Kingdom
Study dates
Jan 2015to 28 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United Kingdom17 sites

  • Brighton & Sussex University Hospitals NHS Trust

    Brighton

  • North Bristol NHS Trust

    Bristol

  • Cardiff and Vale Orthopaedic Centre

    Cardiff

  • Royal Derby Hospital

    Derby, DE22 3NE

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull

  • Aintree University Hospital

    Liverpool, L9 7AL

  • Freeman Hospital

    Newcastle, NE7 7DN

  • Northumbria Healthcare NHS Foundation Trust

    Newcastle

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich

  • Nottingham University Hospitals NHS Trust

    Nottingham

  • Robert Jones & Agnes Hunt Orthopaedic Hospital

    Oswestry, SY10 7AG

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LD

  • Northern General Hospital

    Sheffield, S5 7AU

  • Royal National Orthopaedic Hospital NHS Trust

    Stanmore, HA7 4LP

  • Royal Cornwall Hospitals NHS Trust

    Truro, Cornwall, TR1 3LQ

  • Wrightington Hospital

    Wigan, WN6 9EP

Other trials in United Kingdom

About this study

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.

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

Read the 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
Being tested
Total Ankle Replacement, Arthrodesis
Keywords
ankle arthritis, osteoarthritis, total ankle replacement, arthrodesis, quality of life, musculoskeletal
Medical subject headings
Osteoarthritis, Ankylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Ankle ReplacementProcedure or surgery

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

  • ArthrodesisProcedure or surgery

    Also called Fusion

    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.

Study groups in NCT02128555
Study groupRoleWhat they receive
ArthrodesisActive comparatorAnkle arthrodesis (fusion)
Receives: Procedure: Arthrodesis
Total Ankle ReplacementExperimentalTotal Ankle Replacement
Receives: Procedure: Total Ankle Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre-operation (baseline) to 52 weeks

Secondary outcomes (7)

  1. 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.

    Measured: Pre-operation (baseline) to 26 weeks

  2. 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.

    Measured: Pre-operation (baseline) to 26 and 52 weeks

  3. 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.

    Measured: Pre-operation (baseline) to 26 and 52 weeks

  4. 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.

    Measured: Pre-operation (baseline) to 26 and 52 weeks

  5. 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.

    Measured: Pre-operation (baseline) to 52 weeks

  6. Adverse events

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

    Measured: 52 weeks

  7. 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.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2014 (estimated)
  2. Study startJan 2015
  3. Primary completion23 Dec 2019
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02128555
Sponsor's protocol ID
12/0518
Other IDs
12/35/27, ISRCTN60672307, U1111-1157-4155
Acronym
TARVA
Status last verified
Mar 2021
First submitted
11 Apr 2014
Last updated
15 Mar 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Goldberg AJ, Bordea E, Chowdhury K, Hauptmannova I, Blackstone J, Brooking D, Deane EL, Bendall S, Bing A, Blundell C, Dhar S, Molloy A, Milner S, Karski M, Hepple S, Siddique M, Loveday DT, Mishra V, Cooke P, Halliwell P, Townshend D, Skene SS, Dore CJ; TARVA Study Group. Cost-Utility Analysis of Total Ankle Replacement Compared with Ankle Arthrodesis for Patients Aged 50-85 Years with End-Stage Ankle Osteoarthritis: The TARVA Study. Pharmacoecon Open. 2024 Mar;8(2):235-249. doi: 10.1007/s41669-023-00449-4. Epub 2024 Jan 8.

    PubMed 38189868

  • Goldberg AJ, Chowdhury K, Bordea E, Blackstone J, Brooking D, Deane EL, Hauptmannova I, Cooke P, Cumbers M, Skene SS, Dore CJ. Total ankle replacement versus ankle arthrodesis for patients aged 50-85 years with end-stage ankle osteoarthritis: the TARVA RCT. Health Technol Assess. 2023 Mar;27(5):1-80. doi: 10.3310/PTYJ1146.

    PubMed 37022932

  • Muller P, Skene SS, Chowdhury K, Cro S, Goldberg AJ, Dore CJ; TARVA Study Group. A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan. Trials. 2020 Feb 18;21(1):197. doi: 10.1186/s13063-019-3973-4.

    PubMed 32070409

  • Goldberg AJ, Zaidi R, Thomson C, Dore CJ, Skene SS, Cro S, Round J, Molloy A, Davies M, Karski M, Kim L, Cooke P; TARVA study group. Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Sep 6;6(9):e012716. doi: 10.1136/bmjopen-2016-012716.

    PubMed 27601503

Questions about this trial

What is this clinical trial studying?

A study testing Total Ankle Replacement and Arthrodesis in people with Osteoarthritis, run by University College, London at 17 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported pain-free function domain score (time frame: Pre-operation (baseline) to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02128555, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.

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