NCT05753891

Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Trapeziectomy With Internal Brace Versus Ligament Reconstruction With Tendon Interposition; a Prospective Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Basilar Thumb Arthritis

Interventions

Type	Name	Description
DEVICE	Suture Tape Reconstruction	This intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2023-03-03
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study