NCT02096146

TMT Fusion Plate vs. Two Crossed Screws

TMT Fusion Plate vs. Two Crossed Screws - A Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly assigned to one of these two treatment options.

Detailed description

Tarsometatarsal joint arthrodesis is a common procedure which can be performed using various devices such as screws, plates or both. The Tarsometatarsal Fusion Plate from "DePuySynthes" is a new device designed to encourage bony fusion of the 1st TMT joint, and is expected to lead to earlier fusion compared to the current standard of care of using 2 crossed screws. This is expected, in turn, to result in an earlier reduction in pain and an earlier return to full activity. At this time there is insufficient data directly comparing outcome following surgery for patients treated with screws or plates, and a study protocol which produces a higher level of evidence is therefore necessary. The main aim of this study is to compare patient-reported outcome following surgery for patients undergoing joint arthrodesis using the TMT Fusion plate versus screws only. It is expected that surgery will improve patient-reported outcome similarly for both treatment groups in the long-term, but that the improvement will occur earlier for the plate group. For this study patient-reported outcome will be assessed by the walking/standing and pain domain scores of the Manchester Oxford Foot Questionnaire (MOXFQ). An earlier improvement in any of these two domains would be considered to be valuable. The primary analysis will therefore compare the time to a minimal clinically relevant improvement for any of the two MOXFQ domains for patients treated with TMT fusion plate versus patients treated with only screws during the first 12 months following surgery. An economic evaluation from a societal perspective will determine the incremental cost-effectiveness of the TMT fusion plate versus the 2 crossed screws technique for 1st TMT joint fusion. Therefore a randomized controlled trial will be conducted, where patient-reported outcomes as well as clinical outcome parameters will be assessed.

Conditions

• Clinical Indication for First Metatarsal Joint Arthrodesis

Interventions

Type	Name	Description
PROCEDURE	TMT Fusion plate	Patients are treated with TMT Fusion Plate a post-market device to encourage bony fusion of the 1st TMT joint.
PROCEDURE	Two crossed screws	Patients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-03-26
• Last updated: 2020-08-13

Locations

5 sites across 3 countries: United States, Colombia, United Kingdom