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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06820528
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Julie Nuelle
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Julia A.V. Nuelle, MD
Principal Investigator Affiliation	University of Missouri-Columbia
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	CMC Arthritis, Occupational Therapy, Hand Arthritis

Additional Details

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).

Arms & Interventions

Arms

Experimental: Occupational Therapy

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

Active Comparator: Home Exercise

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Missouri - Columbia, Columbia, Missouri

Status

Address

University of Missouri - Columbia

Columbia, Missouri, 65212

Site Contact

Bryce Fletcher, BS, CCRP

[email protected]

(573) 882-2663

Clinical Trial Finder