Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial.
BMJ Open
; 6(9): e012716, 2016 09 06.
Article
in En
| MEDLINE
| ID: mdl-27601503
INTRODUCTION: 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 50-85â
years. METHODS AND ANALYSIS: TARVA is a multicentre randomised controlled trial that will randomise 328 patients aged 50-85â
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 52â
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 12â
months after surgery. Secondary outcomes include quality-of-life scores, complications, revision, reoperation and a health economic analysis. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT02128555.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Osteoarthritis
/
Postoperative Complications
/
Arthrodesis
/
Arthroplasty, Replacement, Ankle
Type of study:
Clinical_trials
/
Guideline
/
Qualitative_research
Aspects:
Ethics
/
Patient_preference
Limits:
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Journal:
BMJ Open
Year:
2016
Document type:
Article
Country of publication:
United kingdom