Total Ankle Replacement Versus Arthrodesis Trial
TARVA
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.
4 other identifiers
interventional
303
1 country
17
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2029
ExpectedMarch 15, 2021
March 1, 2021
5 years
April 11, 2014
March 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Pre-operation (baseline) to 52 weeks
Secondary Outcomes (7)
Self-reported pain-free function domain score
Pre-operation (baseline) to 26 weeks
Self-reported pain and social interaction domain score
Pre-operation (baseline) to 26 and 52 weeks
Self-reported physical function
Pre-operation (baseline) to 26 and 52 weeks
Self-reported quality of life
Pre-operation (baseline) to 26 and 52 weeks
Range of Motion
Pre-operation (baseline) to 52 weeks
- +2 more secondary outcomes
Study Arms (2)
Arthrodesis
ACTIVE COMPARATORAnkle arthrodesis (fusion)
Total Ankle Replacement
EXPERIMENTALTotal Ankle Replacement
Interventions
The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, TR1 3LQ, 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, DE22 3NE, United Kingdom
Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, United Kingdom
Aintree University Hospital
Liverpool, L9 7AL, United Kingdom
Freeman Hospital
Newcastle, NE7 7DN, 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, SY10 7AG, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LD, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
Royal National Orthopaedic Hospital NHS Trust
Stanmore, HA7 4LP, United Kingdom
Wrightington Hospital
Wigan, WN6 9EP, United Kingdom
Related Publications (4)
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.
PMID: 38189868DERIVEDGoldberg 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.
PMID: 37022932DERIVEDMuller 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.
PMID: 32070409DERIVEDGoldberg 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.
PMID: 27601503DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Goldberg
Royal National Orthopaedic Hospital NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2014
First Posted
May 1, 2014
Study Start
January 1, 2015
Primary Completion
December 23, 2019
Study Completion (Estimated)
February 28, 2029
Last Updated
March 15, 2021
Record last verified: 2021-03