Clinical Indication for First Metatarsal Joint Arthrodesis Clinical Trial
Official title:
TMT Fusion Plate vs. Two Crossed Screws - A Randomized Controlled Trial
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.
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.
;