Recruiting

Woodcasting vs. Thermoplast

Sponsor:

Foundation for Orthopaedic Research and Education

Code:

NCT06876350

Conditions

Carpometacarpal (CMC) Joint Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Woodcasting Splint

Control (Standard treatment)

Study Details

Brief summary:

This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty.

Conditions

Carpometacarpal (CMC) Joint Arthritis

Study ID

NCT06876350

Start date

Oct 3, 2024

Status verified date

Mar, 2025

Completion date

Jun 30, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients over the age of 18 years old.
  • Intact Medical Decision Making
  • Eligible for Surgical Intervention
  • Willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks

Exclusion Criteria:

  • Pregnant Women
  • Deemed Unsuitable by Principal Investigator

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Woodcasting Splint

Woodcasting is an already FDA approved on the market product that is not used a lot so for the purpose of the study we would like to show superior outcomes.

active comparator: Thermoplastic Splint

Thermoplastic splints is an FDA approved on the market orthrosis that is used by Occupational Therapists which is standard of care for patients that undergo CMC arthroplasty.

Interventions

Woodcasting Splint

This is the experimental group so we could see the outcomes and preference for patients using surveys and compliance scores

Control (Standard treatment)

Thermoplastic splints are standard of care treatment for patients after CMC arthroplasty. We will use the data from this group as the comparator to the experimental group.

Primary outcome measure

  • Patient Satisfaction Score [ Time Frame: 6 Weeks ]

Central Contacts and Locations

Central contacts

Andy Nguyen, BS

8139789700anguyen@foreonline.org

Deborah Warren, RN

8139789700dwarren@foreonline.org

Locations

Florida Orthopaedic Institute

Recruiting

Tampa, Florida, United States, 33637

Contacts

Andy Nguyen, BS

8139789700anguyen@foreonline.org

Principal Investigator:

Michael Doarn, MD

More Information

Sponsor

Foundation for Orthopaedic Research and Education

Last update posted

Mar 17, 2025

Last verified

Mar, 2025

Keywords

  • Randomized
  • Hand and Upper Extremity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Foundation for Orthopaedic Research and Education on 2025-03-17.