TMT Fusion Plate vs. Two Crossed Screws

N/ATerminatedNCT02096146

AO Clinical Investigation and Publishing Documentation12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clinical Indication for First Metatarsal Joint Arthrodesis

Interventions

TMT Fusion platePROCEDURE

Patients are treated with TMT Fusion Plate a post-market device to encourage bony fusion of the 1st TMT joint.

Two crossed screwsPROCEDURE

Patients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Mid Michigan Orthopedic Institute - East Lansing

East Lansing, Michigan, United States

Summit Orthopedics

Woodbury, Minnesota, United States

NY Downtown Orthopedic Associates

New York, New York, United States

Centro Médico Imbanaco Cali

Cali, Colombia

Outcomes

Primary Outcomes

Change in the patient-reported MOXFQ

Outcome measures for the study focus on fully validated patient related outcome measures for the foot (MOXFQ).

Time frame: 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

Secondary Outcomes

Development of bone healing assessed based on x-rays

Time frame: 6 and 12 weeks postoperative

Reconstruction of the joint position based on x-rays

Time frame: Pre-operative up to 4 weeks vs. post-operative up to 2 weeks

Change in quality of life (EQ-5D)

Outcome measure of general health

Time frame: 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

Weekly assessed weight bearing during weeks 6-12

Time frame: 3 months FU

Complications related to implant or surgery

For the duration of the study complications are continuously recorded and not restricted to the defined follow up visits.

Time frame: Starts with surgery and is continued until the end of the study (12 months FU)

Documentation of medication and treatment costs

A cost diary to collect treatment costs is distributed and collected at the next FU visit.

Time frame: Starts after surgery and is continued until the end of the study (12 months FU)

Data from ClinicalTrials.gov

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