Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06820528

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

Led by Julie Nuelle · Updated on 2026-06-05

180

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

J

Julie Nuelle

Lead Sponsor

A

Arthrex, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how formal occupational therapy compares with home exercise programs for patients recovering from trapeziectomy and suture suspensionplasty surgery for thumb carpometacarpal (CMC) arthritis. The study aims to determine if in-clinic therapy offers better outcomes than at-home exercises and to analyze the associated costs of each approach, especially considering challenges faced by patients living in rural areas. This is a prospective, randomized, controlled trial designed to provide clear evidence regarding post-operative therapy options. Participants will be randomly assigned to one of two groups: one receives weekly in-clinic occupational therapy sessions lasting 30 to 60 minutes for six weeks, while the other group is given instructions and a booklet for a home exercise program to perform daily at home with occasional physician check-ins during routine follow-ups. The study will compare these two treatment approaches in terms of their effect on recovery and cost differences, including preoperative, intra-operative, and postoperative expenses. Throughout the study, participants' progress will be assessed at multiple time points up to one year after surgery using measures such as the Kapandji Score, radial abduction range, key pinch strength, grip strength, and PROMIS questionnaires on upper extremity function and overall health. The study includes scheduled evaluations at 2 weeks, 6 weeks, 12 weeks, 6 months, and 1 year to monitor recovery and function. This comprehensive follow-up ensures detailed tracking of participant outcomes and therapy effectiveness.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over the age of 18 years
  • Patients undergoing CMC arthroplasty surgery
  • Ability to read and write in English
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - 1 day

Participants undergo trapeziectomy and suture suspensionplasty surgery for thumb carpometacarpal arthritis.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants receive either weekly in-clinic occupational therapy or complete a home exercise program following surgery.

1 to 2 weekly visits depending on assigned therapy

Follow-up

Duration - Up to 1 year

Participants attend follow-up visits to assess recovery and outcomes after surgery and therapy.

Visits at 2 weeks, 6 weeks, 12 weeks, 6 months, and 1 year

Trial Site Locations

Total: 1 location

1

University of Missouri - Columbia

Columbia, Missouri, United States, 65212

Actively Recruiting

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Research Team

B

Bryce T Fletcher, BS, CCRP

V

Vicki Jones, MEd, CCRP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

A Prospective, Randomized Trial of Mobilization Protocols Following Ligament Reconstruction and Tendon Interposition.

Douglas T Hutchinson, Stephanie Sueoka, Angela A Wang...

https://pubmed.ncbi.nlm.nih.gov/30063589

Provision of a Home-Based Video-Assisted Therapy Program Is Noninferior to In-Person Hand Therapy After Thumb Carpometacarpal Arthroplasty.

Patrick C Barrett, Darren T Hackley, Andrea A Yu-Shan...

https://pubmed.ncbi.nlm.nih.gov/38608035