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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Age \>= 40 years old

• Patients undergoing arthroplasty of the first CMC joint including:

‣ Trapeziectomy with LRTI

⁃ Simple Trapeziectomy

⁃ Suspensionplasty (suture vs. APL)

Locations
United States
Illinois
University of Chicago Medicine
RECRUITING
Chicago
Contact Information
Primary
Andrew Straszewski, MD
Andrew.Straszewski@uchospitals.edu
773-834-3531
Backup
Justin Bell
jbell3@bsd.uchicago.edu
Time Frame
Start Date: 2021-04-19
Estimated Completion Date: 2026-08-04
Participants
Target number of participants: 90
Treatments
Active_comparator: 2 weeks of immobilization
Subjects randomized to this arm will be rigidly immobilized in a plaster postoperative thumb spica splint for 2 weeks following their thumb CMC arthroplasty
Active_comparator: 6 weeks of immobilization
Subjects randomized to this arm will be rigidly immobilized in a plaster postoperative thumb spica splint, transitioned to cast, for a total of 6 weeks following their thumb CMC arthroplasty
Related Therapeutic Areas
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov