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

NCT04828954 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-13

No results posted yet for this study

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

Interventions

OTHER

Immobilization for 2-weeks postoperative

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

OTHER

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)

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Jennifer Wolf, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2027-05-04
Completion
2027-08-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04828954 on ClinicalTrials.gov