Woodcasting Versus Thermoplast Splint in CMC Arthroplasty

NCT06876350 | Recruiting

• 1 other identifier: Study007574
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Randomized; Hand and Upper Extremity

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction Score

  The satisfaction survey consists of three questions totaling 15. The minimum value is a 1, while the maximum value is 15. A higher score indicating highest satisfaction.

  6 Weeks

Secondary Outcomes (3)

• Waste

  2 Weeks

• Splint Satisfaction

  6 Weeks

• Splint Issues

  6 Weeks

Study Arms (2)

Woodcasting Splint

EXPERIMENTAL

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.

Other: Woodcasting Splint

Thermoplastic Splint

ACTIVE COMPARATOR

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.

Other: Control (Standard treatment)

Interventions

Woodcasting Splint OTHER

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

Woodcasting Splint

Control (Standard treatment) OTHER

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.

Thermoplastic Splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant Women
• Deemed Unsuitable by Principal Investigator

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

RECRUITING

MeSH Terms

Conditions

Capillary Malformations, Congenital, 1

Study Officials

• Michael Doarn, MD

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andy Nguyen, BS

CONTACT

8139789700; anguyen@foreonline.org

Deborah Warren, RN

CONTACT

8139789700; dwarren@foreonline.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: October 3, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)