Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)
Stopped: Under-enrollment, was not feasible to be completed with a satisfactory sample size.
United States28 participantsStarted 2023-04-01
Plain-language summary
This study seeks to compare two methods of trapeziectomy for basilar thumb arthritis. The first is trapeziectomy with ligament reconstruction and tendon interposition, which means removing the trapezium bone and filling the void with a tendon graft. This is the most commonly used procedure and the control group. The experimental group is trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal. This is using a device called the InternalBrace, produced by Arthrex.
Who can participate
Age range
18 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:
* Patients of Henry Ford Orthopedic Service Line
* Symptomatic basilar thumb arthritis refractory to conservative management
Exclusion Criteria:
* Significant medical comorbidity precluding safe surgery, as determined by the operating surgeon. This may include cardiac disease, renal disease, liver disease, pulmonary disease, or heavy substance abuse.
* Requirement for additional procedures at the 1st carpometacarpal joint, including trapezoid excision-whole or partial-or metacarpal osteotomy. Of note other existing conditions requiring intervention on a separate surgical site such as concomitant carpal tunnel syndrome or trigger fingers will NOT be used as exclusion criteria.
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.