Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb
Recruiting · NCT04828954 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Chicago
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Inclusion criteria
- Age \>= 40 years old
- Patients undergoing arthroplasty of the first CMC joint including:
- Trapeziectomy with LRTI
- Simple Trapeziectomy
- 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
Where it is running
1 location listed across 1 US state.
- University of Chicago Medicine - Chicago, Illinois, United States