Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Henry Ford Health

Status: Enrolling

Conditions: Basilar Thumb Arthritis

Treatments: Device: Suture Tape Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05753891

16162

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Carpometacarpal (CMC) Suture Tape Ligament Reconstruction

Experimental group

Description:

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.

Treatment:

Device: Suture Tape Reconstruction

Carpometacarpal (CMC) Standard Ligament Reconstruction

No Intervention group

Description:

Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.