NCT04828954 Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb
| NCT ID | NCT04828954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Thumb Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-04-19 |
| Primary Completion | 2027-05-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2021-04-19 with a primary completion date of 2027-05-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jennifer Wolf, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT04828954 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Thumb Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04828954 currently recruiting?
Yes, NCT04828954 is actively recruiting participants. Contact the research team at Andrew.Straszewski@uchospitals.edu for enrollment information.
Where is the NCT04828954 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04828954 clinical trial?
NCT04828954 is sponsored by University of Chicago. The principal investigator is Jennifer Wolf, MD at University of Chicago. The trial plans to enroll 90 participants.