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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT04828954
Status
Recruiting
Apply to this trial

Conditions

  • Thumb Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Immobilization for 2-weeks postoperative — OTHER
    Non-removable thumb spica plaster postoperative splint immobilization worn for 2 weeks
  • Immobilization for 6-weeks postoperative — OTHER
    Non-removable postoperative thumb spica splint immobilization worn for 2 weeks (+/- 3 days), to be transitioned to thumb spica cast for an additional 4 weeks (Total of 6 weeks immobilization)

Study Details

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.

Key Dates

Start date
Apr 19, 2021
Status verified
May 2026
Primary completion
May 4, 2027
Completion
Aug 4, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Quick Disabilities of Arm, Shoulder, and Hand (quickDASH) Questionnaire scores [ Time Frame: Change from baseline quickDASH to 3-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago MedicineChicagoIllinois60637
Andrew Straszewski, MD
[email protected]
Jennifer Wolf, MD
[email protected]

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By research site
University of Chicago Medicine· Chicago, IL

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