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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Chicago

About this trial

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

Qualifiers

Age >= 40 years old

Trapeziectomy with LRTI

Simple Trapeziectomy

Suspensionplasty (suture vs. APL)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Immobilization for 2-weeks postoperative
  • Immobilization for 6-weeks postoperative

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators