RECRUITING

Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-04-01
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05753891

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients of Henry Ford Orthopedic Service Line
  2. * Symptomatic basilar thumb arthritis refractory to conservative management
  1. * 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.
  2. * 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.

Contacts and Locations

Study Contact

Hardy Evans, MD
CONTACT
3138057873
hevans3@hfhs.org
Charles Day, MD MBA
CONTACT
3135956428
cday9@hfhs.org

Study Locations (Sites)

Henry Ford Health System
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2023-04-01
Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Basilar Thumb Arthritis