Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Stopped early · Not applicable

Conditions studied: Basilar Thumb Arthritis

In brief

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.

Key facts

Study ID

NCT05753891

Run by

Henry Ford Health System

People needed

28

Starts

2023-04-01

Expected to finish

2024-07-03

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of Henry Ford Orthopedic Service Line
• Symptomatic basilar thumb arthritis refractory to conservative management

You may not qualify if…

• 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.

Where it is running

• Henry Ford Health System — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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