Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial

Abstract

IntroductionTotal 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.Methods and analysisTARVA 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.Ethics and disseminationThe 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 numberNCT02128555.

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

“…Additional outcomes are also collected for a detailed cost and cost-effectiveness analysis of TAR versus ankle arthrodesis; however, this analysis will not be performed by the TARVA statistical team so these outcomes are not described here. Further details on the cost effectiveness analysis can be found in the trial protocol [6].…”

“…The protocol has previously been published [6]. Following completion of the trial analysis the results will be published, and additional available data can be obtained by contacting the chief investigator (AJG).…”

“…TARVA is a parallel-group, non-blinded randomised controlled trial that will compare clinical outcomes and cost-effectiveness of TAR versus ankle arthrodesis in patients with end-stage ankle Osteoarthritis (OA). Full details of the background to the trial, the interventions under study and its design are in the published trial protocol [6]. From March 2015 to January 2019, 303 patients were randomised to surgery at one of 17 surgical centres participating in the trial in England, UK.…”

Ankle Arthrodesis using Ilizarov Ring Fixator: A Primary or Salvage Procedure? An Analysis of Twenty Cases

“…The techniques recorded in literature for arthrodesis up until now include crossed screw structure (two screws inserted from the distal tibia, across to each other, into the talus), intramedullary nail, plate, external fixation frame and so forth; however, there remains much controversy with respect to the optimal technique for ankle fusion to acquire steady rigid fixation, fixation methods that does not allow interfragmentary movement under functional weight bearing and utilizes the compression principle, accompanying restoration of plantigrade foot function 3 - 6 . Furthermore, existing techniques are associated with several complications such as malalignment, infection, nonunion, and adjacent joint osteoarthritis 7 .…”

Response to review article published titled ‘Total ankle arthroplasty versus ankle arthrodesis - a comparison of outcomes over the last decade’

“…However, we feel that no conclusions can be made from the pooled analysis, and there is little merit reporting this, given the limitations of primary studies in defining endpoints consistently, heterogeneous clinical indications for surgery, and imprecise surgical treatment definitions. Some clarity on which modality is superior for ankle osteoarthritis may be reached from the large multicentre TARVA (TAR versus AA) RCT currently underway [5]. There is a need for longer-term cohort studies investigating these treatments to allow for subgroup analysis for specific surgical treatments, population types, and indications for surgery.…”