← Back to all trials
Not Yet Recruiting
NCT05753891
Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)
Conditions: Basilar Thumb Arthritis
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 48
Sponsor: Henry Ford Health System
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.
Eligibility Criteria
Inclusion Criteria:Patients of Henry Ford Orthopedic Service LineSymptomatic basilar thumb arthritis refractory to conservative managementExclusion 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.
Source: ClinicalTrials.gov (NCT05753891). StuddyBuddy aggregates publicly available trial information.