NCT06820528

Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Julie Nuelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty

Detailed description

While hand surgeons agree that strength and flexibility exercises are crucial after surgery, there is currently no consensus on whether the benefits of participating in formal hand therapy outweigh the investment required. The financial and time investments required to participate in formal hand therapy can be particularly large in patients living in rural locations, as access to certified hand therapists are often limited. Therefore, a prospective, randomized trial of hand therapy utilization is warranted to explore this phenomenon. The purpose of this clinical trial is to assess the outcomes for post-operative therapy from in-clinic or at-home exercise therapies and analyze costs associated with the different therapies. For this clinical trial patients will be randomized to either in-clinic occupational therapy where patients come into clinic and undergo about 30-60 minutes of occupational therapy 1-2 a week with a physician or at-home exercise therapy where patients are provided instructions in clinic prior to HEP-therapy and have check-ins with physicians at their normal follow-up appointments; each consisting of about 5-10 minutes of exercise at home everyday of the week. This study is a prospective, randomized, controlled trial to asses and analyze: 1. The outcomes after trapeziectomy and suture suspensionplasty with in-clinic occupational therapy (OT) and without in-clinic occupational therapy: home exercise program (HEP). 2. The cost difference between the OT and HEP groups as well as historical control patients that have undergone LRTI for thumb carpometacarpal joint arthritis (Including preoperative, intra-operative, and postoperative costs).

Conditions

• CMC Arthritis
• Occupational Therapy
• Hand Arthritis

Interventions

Type	Name	Description
BEHAVIORAL	Occupational Therapy	Formal therapy with a certified hand therapist, weekly for 6 weeks
BEHAVIORAL	Home Exercise Program	A booklet on hand exercises to complete following surgery, including range of motion and strengthening exercises

Timeline

• Start date: 2025-04-17
• Primary completion: 2027-07-01
• Completion: 2028-01-01
• First posted: 2025-02-11
• Last updated: 2025-04-25

Locations

1 site across 1 country: United States