TerminatedNot Applicable

TMT Fusion Plate vs. Two Crossed Screws

Stopped: Lack of enrolment

United States, Colombia, United Kingdom12 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT02096146

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

View on ClinicalTrials.gov More Clinical Indication for First Metatarsal Joint Arthrodesis trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.