Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial
<h4>Introduction</h4> <p>Total ankle replacement (TAR) or ankle arthrodesis (fusion) is the main surgical treatments for end-stage ankle osteoarthritis (OA). The popularity of ankle replacement is increasing while ankle fusion rates remain static. Both treatments have efficacy but...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Published: |
BMJ Publishing Group
2016
|
| _version_ | 1826288874794516480 |
|---|---|
| author | Goldberg, A Zaidi, R Thomson, C Dore, C Skene, S Cro, S Round, J Molloy, A Davies, M Karski, M Kim, L Cooke, P |
| author_facet | Goldberg, A Zaidi, R Thomson, C Dore, C Skene, S Cro, S Round, J Molloy, A Davies, M Karski, M Kim, L Cooke, P |
| author_sort | Goldberg, A |
| collection | OXFORD |
| description | <h4>Introduction</h4> <p>Total ankle replacement (TAR) or ankle arthrodesis (fusion) is the main surgical treatments for end-stage ankle osteoarthritis (OA). The popularity of ankle replacement is increasing while ankle fusion rates remain static. Both treatments have efficacy but to date all studies comparing the 2 have been observational without randomisation, and there are no published guidelines as to the most appropriate management. The TAR versus arthrodesis (TARVA) trial aims to compare the clinical and cost-effectiveness of TAR against ankle arthrodesis in the treatment of end-stage ankle OA in patients aged 50–85 years.</p> <h4>Methods and analysis</h4> <p>TARVA is a multicentre randomised controlled trial that will randomise 328 patients aged 50–85 years with end-stage ankle arthritis. The 2 arms of the study will be TAR or ankle arthrodesis with 164 patients in each group. Up to 16 UK centres will participate. Patients will have clinical assessments and complete questionnaires before their operation and at 6, 12, 26 and 52 weeks after surgery. The primary clinical outcome of the study is a validated patient-reported outcome measure, the Manchester Oxford foot questionnaire, captured preoperatively and 12 months after surgery. Secondary outcomes include quality-of-life scores, complications, revision, reoperation and a health economic analysis.</p> <h4>Ethics and dissemination</h4> <p>The protocol has been approved by the National Research Ethics Service Committee (London, Bloomsbury 14/LO/0807). This manuscript is based on V.5.0 of the protocol. The trial findings will be disseminated through peer-reviewed publications and conference presentations.</p> |
| first_indexed | 2024-03-07T02:20:19Z |
| format | Journal article |
| id | oxford-uuid:a3b29555-e7f0-4863-96f6-256d049d331c |
| institution | University of Oxford |
| last_indexed | 2024-03-07T02:20:19Z |
| publishDate | 2016 |
| publisher | BMJ Publishing Group |
| record_format | dspace |
| spelling | oxford-uuid:a3b29555-e7f0-4863-96f6-256d049d331c2022-03-27T02:28:48ZTotal ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:a3b29555-e7f0-4863-96f6-256d049d331cSymplectic Elements at OxfordBMJ Publishing Group2016Goldberg, AZaidi, RThomson, CDore, CSkene, SCro, SRound, JMolloy, ADavies, MKarski, MKim, LCooke, P <h4>Introduction</h4> <p>Total ankle replacement (TAR) or ankle arthrodesis (fusion) is the main surgical treatments for end-stage ankle osteoarthritis (OA). The popularity of ankle replacement is increasing while ankle fusion rates remain static. Both treatments have efficacy but to date all studies comparing the 2 have been observational without randomisation, and there are no published guidelines as to the most appropriate management. The TAR versus arthrodesis (TARVA) trial aims to compare the clinical and cost-effectiveness of TAR against ankle arthrodesis in the treatment of end-stage ankle OA in patients aged 50–85 years.</p> <h4>Methods and analysis</h4> <p>TARVA is a multicentre randomised controlled trial that will randomise 328 patients aged 50–85 years with end-stage ankle arthritis. The 2 arms of the study will be TAR or ankle arthrodesis with 164 patients in each group. Up to 16 UK centres will participate. Patients will have clinical assessments and complete questionnaires before their operation and at 6, 12, 26 and 52 weeks after surgery. The primary clinical outcome of the study is a validated patient-reported outcome measure, the Manchester Oxford foot questionnaire, captured preoperatively and 12 months after surgery. Secondary outcomes include quality-of-life scores, complications, revision, reoperation and a health economic analysis.</p> <h4>Ethics and dissemination</h4> <p>The protocol has been approved by the National Research Ethics Service Committee (London, Bloomsbury 14/LO/0807). This manuscript is based on V.5.0 of the protocol. The trial findings will be disseminated through peer-reviewed publications and conference presentations.</p> |
| spellingShingle | Goldberg, A Zaidi, R Thomson, C Dore, C Skene, S Cro, S Round, J Molloy, A Davies, M Karski, M Kim, L Cooke, P Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial |
| title | Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial |
| title_full | Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial |
| title_fullStr | Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial |
| title_full_unstemmed | Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial |
| title_short | Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial |
| title_sort | total ankle replacement versus arthrodesis tarva protocol for a multicentre randomised controlled trial |
| work_keys_str_mv | AT goldberga totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT zaidir totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT thomsonc totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT dorec totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT skenes totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT cros totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT roundj totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT molloya totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT daviesm totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT karskim totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT kiml totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial AT cookep totalanklereplacementversusarthrodesistarvaprotocolforamulticentrerandomisedcontrolledtrial |