Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-17

Study Completion Date

2028-01-01

Brief Summary

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

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Detailed Description

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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

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CMC Arthritis Occupational Therapy Hand Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be prospectively enrolled into two arms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Occupational Therapy

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

Group Type EXPERIMENTAL

Occupational Therapy

Intervention Type BEHAVIORAL

Formal therapy with a certified hand therapist, weekly for 6 weeks

Home Exercise

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

Group Type ACTIVE_COMPARATOR

Home Exercise Program

Intervention Type BEHAVIORAL

A booklet on hand exercises to complete following surgery, including range of motion and strengthening exercises

Interventions

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Occupational Therapy

Formal therapy with a certified hand therapist, weekly for 6 weeks

Intervention Type BEHAVIORAL

Home Exercise Program

A booklet on hand exercises to complete following surgery, including range of motion and strengthening exercises

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No