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

NCT04828954 | Recruiting

• 1 other identifier: IRB20-1651
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Thumb carpometacarpal joint osteoarthritis; Rehabilitation; Hand therapy

Outcome Measures

Primary Outcomes (1)

• Quick Disabilities of Arm, Shoulder, and Hand (quickDASH) Questionnaire scores

  The 11 question disability survey will be scored if at least 10 of the items are completed. The average score of responses (maximum of 5) will be obtained and transformed into score of 0 to 100 by subtracting one and multiplying by 25. A higher score indicated greater disability. The scores between treatment arms will be compared, as well as comparison of baseline scores with subsequent follow-up scores within each treatment arm. Administered at baseline visit, and 2-week, 6-week, 3-month and 1-year post-operative follow up visits.

  Change from baseline quickDASH to 3-months

Secondary Outcomes (2)

• Visual Analog Scale (VAS) Pain scale

  Change from baseline VAS to 3-months

• Patient-Reported Outcome Measures Information System (PROMIS) Upper Extremity scores

  Change from baseline PROMIS to 3-months

Study Arms (2)

2 weeks of immobilization

ACTIVE COMPARATOR

Subjects randomized to this arm will be rigidly immobilized in a plaster postoperative thumb spica splint for 2 weeks following their thumb CMC arthroplasty

Other: Immobilization for 2-weeks postoperative

6 weeks of immobilization

ACTIVE COMPARATOR

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

Other: Immobilization for 6-weeks postoperative

Interventions

Immobilization for 2-weeks postoperative OTHER

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

2 weeks of immobilization

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)

6 weeks of immobilization

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 40 years old
• Patients undergoing arthroplasty of the first CMC joint including:
• Trapeziectomy with LRTI
• Simple Trapeziectomy
• Suspensionplasty (suture vs. APL)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Interventions

Immobilization; Postoperative Period

Intervention Hierarchy (Ancestors)

Investigative Techniques; Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jennifer Wolf, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Straszewski, MD

CONTACT

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

Justin Bell

CONTACT

jbell3@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Occupational therapy (blinded to length of immobilization)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: April 19, 2021
• Primary Completion: May 4, 2026
• Study Completion (Estimated): August 4, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)