Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Study Overview
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Brief Summary
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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.

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

Conditions
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Basilar Thumb Arthritis

Intervention / Treatment
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* Device: Suture Tape Reconstruction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carpometacarpal (CMC) Suture Tape Ligament Reconstruction<br>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. | Device: Suture Tape Reconstruction<br>* 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.<br>* Other names: Arthrex InternalBrace;|
| No Intervention: Carpometacarpal (CMC) Standard Ligament Reconstruction<br>Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pinch Strength | Pinch Strength measurements | 6 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS-UE | Patient-Reported outcomes measurement information system (PROMIS) Upper Extremity (UE) item bank to record upper extremity function. | 6 months post procedure |