Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb (NCT04828954)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (7 items).
Location: University of Chicago Medicine — Chicago, Illinois
Age range: 40 Years
🧪 Interventions in This Study
- Immobilization for 2-weeks postoperative (OTHER)
- Immobilization for 6-weeks postoperative (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Chicago Medicine — Chicago, Illinois
📞 Contact the Study Coordinator
Phone: (773) 834-3531
Email: Andrew.Straszewski@uchospitals.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Thumb Osteoarthritis
- Turmeric for Patients With Basal Joint Arthritis — Boston, Massachusetts
- NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis — Rochester, Minnesota
Explore by condition: All Thumb Osteoarthritis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.