TerminatedNot Applicable

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 range18 Years

SexALL

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.

What they're measuring

Pinch Strength

Timeframe: 6 months post procedure

Trial details

NCT IDNCT05753891

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-03

Results submitted2025-07-21

View on ClinicalTrials.gov More Basilar Thumb Arthritis trials