Clinical Indication for First Metatarsal Joint Arthrodesis
Conditions
Keywords
Plate, Hallux valgus, Foot deformity, Screw, Tarsometatarsal angle, Cost effectiveness
Brief 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.
Interventions
PROCEDURETMT Fusion plate
Patients are treated with TMT Fusion Plate a post-market device to encourage bony fusion of the 1st TMT joint.
PROCEDURETwo crossed screws
Patients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion.
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: between 18 and 65 years * At least one of the following: * 1st TMT arthritis * hallux valgus (intermetatarsal angle (IM) 1-2 angle \> 15° on plain x-ray) * 1st ray hypermobility with or without flat foot * Painful condition * Ability to understand the content of the patient information / Informed Consent Form * Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP) * Signed and dated IRB/EC-approved written informed consent
Exclusion criteria
* Active infection * Previous surgery on the 1st ray of the same foot * Previous non-union on the 1st ray of the same foot * Clinical obvious arthritis in other joints of the lower extremities * Purely seeking plastic surgery * Peripheral vascular disease (e.g. advanced diabetes) * Peripheral sensory neuropathy (e.g. advanced diabetes) * Concurrent surgery of the contralateral foot * Any previously medically unmanaged severe systemic disease * Substance abuse that would preclude reliable assessment * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the patient-reported MOXFQ | Up to 4 weeks pre-operative, Discharge (up to 1 week post-operative), 2 week FU, 6 week FU, 3 month FU, 6 month FU, 12 month FU | Outcome measures for the study focus on fully validated patient related outcome measures for the foot (MOXFQ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reconstruction of the joint position based on x-rays | Pre-operative up to 4 weeks vs. post-operative up to 2 weeks | — |
| Change in quality of life (EQ-5D) | Up to 4 weeks pre-operative, discharge (up to 1 week post-op), 2 weeks FU, 6 weeks FU, 3 months FU, 6 months FU, 12 months FU | Outcome measure of general health |
| Development of bone healing assessed based on x-rays | 6 and 12 weeks postoperative | — |
| Complications related to implant or surgery | Starts with surgery and is continued until the end of the study (12 months FU) | For the duration of the study complications are continuously recorded and not restricted to the defined follow up visits. |
| Documentation of medication and treatment costs | Starts after surgery and is continued until the end of the study (12 months FU) | A cost diary to collect treatment costs is distributed and collected at the next FU visit. |
| Weekly assessed weight bearing during weeks 6-12 | 3 months FU | — |
Countries
Colombia, United Kingdom, United States
Outcome results
None listed