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

Julie Nuelle

Status: Enrolling

Conditions: Occupational Therapy; CMC Arthritis; Hand Arthritis

Treatments: Behavioral: Occupational Therapy; Behavioral: Home Exercise Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06820528

CMC-02062

Details and patient eligibility

About

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

Full 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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over the age of 18 years
• Patients undergoing CMC Arthroplasty
• Ability to read and write in English
• Ability to provide informed consent

Exclusion criteria

• Patients undergoing revision CMC arthroplasty
• Acute traumatic dislocation of the CMC joint as indication for surgery
• Concomitant treatment of MCP hyperextension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Occupational Therapy

Experimental group

Description:

Participants in this arm will receive weekly occupational therapy for 6 weeks

Treatment:

Behavioral: Occupational Therapy

Home Exercise

Active Comparator group

Description:

Participants in this arm will complete an informal home exercise program provided by their treating physician

Treatment:

Behavioral: Home Exercise Program