Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Not Applicable

Recruiting

• Conditions: Basilar Thumb Arthritis
• Interventions: Device: Suture Tape Reconstruction

• Registration Number: NCT05753891
• Lead Sponsor: Henry Ford Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-03
• Study Start: 2023-04-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carpometacarpal (CMC) Suture Tape Ligament Reconstruction	Suture Tape 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.

Primary Outcome Measures

Name	Time	Method
Pinch Strength	6 months post procedure	Pinch Strength measurements

Secondary Outcome Measures

Name	Time	Method
PROMIS-UE	6 months post procedure	Patient-Reported outcomes measurement information system (PROMIS) Upper Extremity (UE) item bank to record upper extremity function.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States