Trapeziectomy With Internal Brace Versus Ligament Reconstruction With Tendon Interposition; a Prospective Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients of Henry Ford Orthopedic Service Line
• Symptomatic basilar thumb arthritis refractory to conservative management
Locations
United States
Michigan
Henry Ford Health System
RECRUITING
Detroit
Contact Information
Primary
Hardy Evans, MD
hevans3@hfhs.org
3138057873
Backup
Charles Day, MD MBA
cday9@hfhs.org
3135956428
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 48
Treatments
Experimental: Carpometacarpal (CMC) Suture Tape Ligament Reconstruction
Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group.
No_intervention: Carpometacarpal (CMC) Standard Ligament Reconstruction
Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.
Related Therapeutic Areas
Sponsors
Leads: Henry Ford Health System