RECRUITING

Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb

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

Thumb carpometacarpal (CMC) osteoarthritis (OA) is common, seen frequently in middle-aged and elderly women. While a variety of surgical treatments have been described with none superior to any other, there is no consensus on the optimal duration of postoperative immobilization. Immobilization following surgery is critical for wound healing, pain control, and aid with activities of daily living in the early recovery period, though the duration of this must be weighed against the negative impacts of immobilization, such as stiffness, contracture, and delay in return to full function. The information gained in this study may allow hand surgeons to use an evidence-based postoperative rehabilitation protocol. Thus, our goal is to compare varying durations of postoperative immobilization after thumb CMC arthroplasty in a randomized trial design. Subjects will be randomized to treatment with non-removable thumb spica plaster postoperative splint immobilization for 2 weeks or non-removable thumb spica plaster splint transitioned to cast for a total of 6 weeks immobilization following base of thumb arthroplasty. Patient-reported outcome measures (PROs) and objective metrics will be tracked in the follow-up period.

Official Title

Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb

Quick Facts

Study Start:2021-04-19
Study Completion:2025-08-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04828954

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:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 40 years old
  2. * Patients undergoing arthroplasty of the first CMC joint including:
  3. 1. Trapeziectomy with LRTI
  4. 2. Simple Trapeziectomy
  5. 3. Suspensionplasty (suture vs. APL)
  1. * Patients \< 40 years of age
  2. * Patients who have undergone prior surgical procedures on the thumb base
  3. * Patients with history of prior procedure at the base of thumb, or those with plan for concomitant carpal tunnel release or thumb metacarpophalangeal (MCP) arthrodesis, will be excluded. Concomitant carpal tunnel surgery may skew outcome surveys, and an arthrodesis procedure will warrant a longer length of immobilization following procedure.
  4. * Those undergoing implant arthroplasty
  5. * Patients with a diagnosis of inflammatory arthritis
  6. * Patients with diagnosis of hypermobility syndrome

Contacts and Locations

Study Contact

Andrew Straszewski, MD
CONTACT
773-834-3531
Andrew.Straszewski@uchospitals.edu
Justin Bell
CONTACT
jbell3@bsd.uchicago.edu

Principal Investigator

Jennifer Wolf, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago Medicine
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Jennifer Wolf, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

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 Date2021-04-19
Study Completion Date2025-08-04

Study Record Updates

Study Start Date2021-04-19
Study Completion Date2025-08-04

Terms related to this study

Keywords Provided by Researchers

  • Thumb carpometacarpal joint osteoarthritis
  • Rehabilitation
  • Hand therapy

Additional Relevant MeSH Terms

  • Thumb Osteoarthritis