Recruiting

Postoperative Immobilization

Sponsor:

University of Chicago

Code:

NCT04828954

Conditions

Thumb Osteoarthritis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Immobilization for 2-weeks postoperative

Immobilization for 6-weeks postoperative

Study Details

Brief 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.

Conditions

Thumb Osteoarthritis

Study ID

NCT04828954

Start date

Apr 19, 2021

Status verified date

May, 2026

Completion date

Aug 4, 2027

Anticipated

Primary completion date

May 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 40 years old
  • Patients undergoing arthroplasty of the first CMC joint including:

1. Trapeziectomy with LRTI
2. Simple Trapeziectomy
3. Suspensionplasty (suture vs. APL)

Exclusion Criteria:

  • Patients < 40 years of age
  • Patients who have undergone prior surgical procedures on the thumb base
  • 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.
  • Those undergoing implant arthroplasty
  • Patients with a diagnosis of inflammatory arthritis
  • Patients with diagnosis of hypermobility syndrome

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Immobilization for 2-weeks postoperative

Non-removable thumb spica plaster postoperative splint immobilization worn for 2 weeks

Immobilization for 6-weeks postoperative

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)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Andrew Straszewski, MD

773-834-3531Andrew.Straszewski@uchospitals.edu

Justin Bell

jbell3@bsd.uchicago.edu

Locations

University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Andrew Straszewski, MD

Andrew.Straszewski@uchospitals.edu

Jennifer Wolf, MD

jwolf@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • Thumb carpometacarpal joint osteoarthritis
  • Rehabilitation
  • Hand therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-05-13.