| ID | Type | Description | Link |
|---|---|---|---|
| 12/35/27 | Other Grant/Funding Number | NIHR HTA | |
| ISRCTN60672307 | Registry Identifier | ISRCTN | |
| U1111-1157-4155 | Registry Identifier | Universal Trial Number |
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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthrodesis | Active Comparator | Ankle arthrodesis (fusion) |
|
| Total Ankle Replacement | Experimental | Total Ankle Replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Ankle Replacement | Procedure | The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Self-reported pain and social interaction domain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Goldberg | Royal National Orthopaedic Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Cornwall Hospitals NHS Trust | Truro | Cornwall | TR1 3LQ | United Kingdom | ||
| Brighton & Sussex University Hospitals NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38189868 | Derived | 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. | |
| 37022932 |
| Label | URL |
|---|---|
| TARVA website | View source |
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| 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. |
|
|
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 | 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 | 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 | 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 | To compare the safety of TAR versus arthrodesis in terms of complications and adverse events. | 52 weeks |
| 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 |
| 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 |
| Derived |
| 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. |
| 32070409 | Derived | 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. |
| 27601503 | Derived | 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. |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D058737 | Arthroplasty, Replacement, Ankle |
| D001174 | Arthrodesis |
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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