Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Basilar Thumb Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753891
• Other study ID #: 16162
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Henry Ford Health System
• Contact: Hardy Evans, MD
• Phone: 3138057873
• Email: hevans3[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Basilar Thumb Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pinch Strength	Pinch Strength measurements	6 months post procedure
Secondary	PROMIS-UE	Patient-Reported outcomes measurement information system (PROMIS) Upper Extremity (UE) item bank to record upper extremity function.	6 months post procedure