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Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Primary Purpose

Basilar Thumb Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suture Tape Reconstruction
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basilar Thumb Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Carpometacarpal (CMC) Suture Tape Ligament Reconstruction

    Carpometacarpal (CMC) Standard Ligament Reconstruction

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Pinch Strength
    Pinch Strength measurements

    Secondary Outcome Measures

    PROMIS-UE
    Patient-Reported outcomes measurement information system (PROMIS) Upper Extremity (UE) item bank to record upper extremity function.

    Full Information

    First Posted
    February 23, 2023
    Last Updated
    March 16, 2023
    Sponsor
    Henry Ford Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05753891
    Brief Title
    Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)
    Official Title
    Trapeziectomy With Internal Brace Versus Ligament Reconstruction With Tendon Interposition; a Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    January 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Henry Ford Health System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Basilar Thumb Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Carpometacarpal (CMC) Suture Tape Ligament Reconstruction
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Carpometacarpal (CMC) Standard Ligament Reconstruction
    Arm Type
    No Intervention
    Arm Description
    Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.
    Intervention Type
    Device
    Intervention Name(s)
    Suture Tape Reconstruction
    Other Intervention Name(s)
    Arthrex InternalBrace
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pinch Strength
    Description
    Pinch Strength measurements
    Time Frame
    6 months post procedure
    Secondary Outcome Measure Information:
    Title
    PROMIS-UE
    Description
    Patient-Reported outcomes measurement information system (PROMIS) Upper Extremity (UE) item bank to record upper extremity function.
    Time Frame
    6 months post procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hardy Evans, MD
    Email
    hevans3@hfhs.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charles Day, MD MBA
    Phone
    3135956428
    Email
    cday9@hfhs.org

    12. IPD Sharing Statement

    Learn more about this trial

    Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

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