TMT Fusion Plate vs. Two Crossed Screws

Stopped early · Not applicable

Conditions studied: Clinical Indication for First Metatarsal Joint Arthrodesis

In brief

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.

Key facts

Study ID

NCT02096146

Run by

AO Clinical Investigation and Publishing Documentation

People needed

12

Starts

2014-10-01

Expected to finish

2016-08-01

Last updated by the study team

2020-08-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Ian Winson — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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