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NCT05753891 | RECRUITING | Basilar Thumb Arthritis

Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)
Sponsor:

Henry Ford Health System

Information provided by (Responsible Party):

Charles S Day

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.

Condition or disease

Basilar Thumb Arthritis

Intervention/treatment

Suture Tape Reconstruction

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Trapeziectomy With Internal Brace Versus Ligament Reconstruction With Tendon Interposition; a Prospective Study
Actual Study Start Date : 2023-04-01
Estimated Primary Completion Date : 2025-01-01
Estimated Study Completion Date : 2025-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Location Details

NCT05753891

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Locations

RECRUITING

United States, Michigan

Henry Ford Health System

Detroit, Michigan, United States, 48202