TMT fusion RCT
Research type
Research Study
Full title
TMT Fusion Plate vs. 2 crossed screws – A Randomized Controlled Trial
IRAS ID
143229
Contact name
Katrin Stadelmann
Contact email
Sponsor organisation
A O Foundation
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 2 days
Research summary
The study to be undertaken will look at the treatment of arthritis or instability of a major joint in the foot, the first Tarsometatarsal joint(TMTJ).The study will compare a TMTJ Fusion Plate versus two crossed screws for the fixation of the joint,the only variation will be the fixation device used in an otherwise standard surgical treatment of this condition. The Study will be as a randomised controlled trail.Patients who meet eligibility criteria and sign informed consent will be randomly assigned to one of these two treatment options.
The first objective of the study is to assess whether treatment with the plate leads to an earlier clinically relevant improvement using a patient-reported outcome (MOXFQ) during the first 12 months following surgery as compared to treatment with screws.Other outcomes will be assessed with standard clinical assessment of complications and radiological studies which would be a standard of care if the study were not being undertaken.
The cost effectiveness of the TMT fusion plate versus the 2 crossed screws technique for 1st TMT joint fusion will be studied. This project therefore aims to cover clinical, patient-reported and economic aspects of this form of treatment.
REC name
South West - Frenchay Research Ethics Committee
REC reference
14/SW/1147
Date of REC Opinion
6 Feb 2015
REC opinion
Further Information Favourable Opinion