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TMT Fusion Plate vs. Two Crossed Screws

NCT02096146 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-08-13

No results posted yet for this study

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.

Conditions

  • Clinical Indication for First Metatarsal Joint Arthrodesis

Interventions

PROCEDURE

TMT Fusion plate

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

PROCEDURE

Two crossed screws

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

Sponsors & Collaborators

  • AO Clinical Investigation and Publishing Documentation

    lead OTHER

Principal Investigators

  • Ian Winson, MB ChB, FRCS · Southmead Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States
  • Colombia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096146 on ClinicalTrials.gov