Internal Brace vs. Ligament Reconstruction for Thumb Arthritis

Overseen By Charles Day, MD MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Cardiac, Renal, Liver, Pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day (surgical procedure)

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for patients under the care of Henry Ford Orthopedic Service Line with painful thumb arthritis that hasn't improved with standard treatments. It's not suitable for those with serious health issues like heart, kidney, liver, or lung diseases, or heavy substance abuse. People needing other thumb joint procedures can't join.

Inclusion Criteria

My thumb arthritis pain persists despite treatment.

Patients of Henry Ford Orthopedic Service Line

Exclusion Criteria

I have a serious health condition that makes surgery unsafe for me.

I need surgery on my thumb joint but not for carpal tunnel or trigger fingers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo trapeziectomy with either ligament reconstruction and tendon interposition or suture tape suspension using the InternalBrace device

1 day (surgical procedure)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of upper extremity function and pinch strength

6 months

Treatment Details

Interventions

• Suture Tape Reconstruction

Trial Overview The study compares two surgical techniques for thumb arthritis after removing a wrist bone (trapeziectomy). One group receives a tendon graft (control), while the other uses an InternalBrace device to connect thumb and index finger bones (experimental).

Participant Groups

Group I: Carpometacarpal (CMC) Suture Tape Ligament Reconstruction Experimental Treatment 1 Intervention

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.

Group II: Carpometacarpal (CMC) Standard Ligament Reconstruction Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+