Woodcasting Versus Thermoplast Splint in CMC Arthroplasty (Woodcast)

Patient Satisfaction for Post-Operative Carpometacarpal Arthroplasty: Wood Casting Versus Thermoplastic Splint

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

Study Overview

• Status: Recruiting
• Conditions: Carpometacarpal (CMC) Joint Arthritis
• Intervention / Treatment: Other: Woodcasting Splint; Other: Control (Standard treatment)

Detailed Description

Patients undergoing carpometacarpal arthroplasty will be randomized into the woodcast or thermoplast splint after their surgery to see which is preferred using compliance and surveys.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andy Nguyen, BS; Phone Number: 6837 8139789700; Email: anguyen@foreonline.org
• Study Contact Backup: Name: Deborah Warren, RN; Phone Number: 8139789700; Email: dwarren@foreonline.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Recruiting
      • Florida Orthopaedic Institute
      • Contact: Michael Doarn, MD
      • Contact: Andy Nguyen, BS; Phone Number: 6837 8139789700; Email: anguyen@foreonline.org
      • Contact: Alfred Hess, MD
      • Contact: Ronald Mitchell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Woodcasting Splint; This is the experimental group so we could see the outcomes and preference for patients using surveys and compliance scores
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waste	Each splint group creates waste for the fabrication and molding for each patient which will be recorded by the clinical research coordinator and weighed out.	2 Weeks
Splint Satisfaction	Patient will have three questions totaling 15 with the higher score indicating highest satisfaction.	6 Weeks
Splint Issues	A single question will be filled out by patients on a scale of 1-5 with a score of 5 indicating a lot of issues with their splint.	6 Weeks

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Investigators: Principal Investigator: Michael Doarn, MD, Florida Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Randomized; Hand and Upper Extremity
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis
• Other Study ID Numbers: Study007574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Each participant data will be grouped for each cohort and averaged, so individual participant data is not necessary to perform a data analysis of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No