Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

NCT ID: NCT05753891

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-01-01

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.

Detailed Description

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Conditions

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Basilar Thumb Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carpometacarpal (CMC) Suture Tape Ligament 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.

Group Type EXPERIMENTAL

Suture Tape Reconstruction

Intervention Type DEVICE

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.

Carpometacarpal (CMC) Standard Ligament Reconstruction

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Arthrex InternalBrace

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Charles S Day

Interim Chairman & Medical Director, Professor of Orthopaedic Surgery, Department of Orthopaedic Surgery & Service Line, Wayne State University School of Medicine, Henry Ford Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hardy Evans, MD

Role: CONTACT

3138057873

Charles Day, MD MBA

Role: CONTACT

3135956428

Facility Contacts

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Charles S Day, M.D., M.B.A.

Role: primary

313-916-5846

Elizabeth A Washnock-Schmid, B.S.

Role: backup

8103474714

Other Identifiers

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16162

Identifier Type: -

Identifier Source: org_study_id

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