Clinical trial NCT02096146: TMT Fusion Plate vs. Two Crossed Screws
Official title: TMT Fusion Plate vs. Two Crossed Screws - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Clinical Indication for First Metatarsal Joint Arthrodesis
Keywords: Plate
Hallux valgus
Foot deformity
Screw
Tarsometatarsal angle
Cost effectiveness
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the patient-reported MOXFQ
timeFrame: 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:
measure: Development of bone healing assessed based on x-rays
timeFrame: 6 and 12 weeks postoperative
measure: Reconstruction of the joint position based on x-rays
timeFrame: Pre-operative up to 4 weeks vs. post-operative up to 2 weeks
measure: Change in quality of life (EQ-5D)
timeFrame: 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
measure: Weekly assessed weight bearing during weeks 6-12
timeFrame: 3 months FU
measure: Complications related to implant or surgery
timeFrame: Starts with surgery and is continued until the end of the study (12 months FU)
measure: Documentation of medication and treatment costs
timeFrame: Starts after surgery and is continued until the end of the study (12 months FU)
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Mid Michigan Orthopedic Institute - East Lansing
state: Michigan
city: Woodbury
country: United States
facility: Summit Orthopedics
state: Minnesota
city: New York
country: United States
facility: NY Downtown Orthopedic Associates
state: New York
city: Cali
country: Colombia
facility: Centro Médico Imbanaco Cali
city: Bristol
country: United Kingdom
facility: Ian Winson
Study officials:
affiliation: Southmead Hospital
name: Ian Winson, MB ChB, FRCS
role: PRINCIPAL_INVESTIGATOR
References: