Woodcasting Versus Thermoplast Splint in CMC Arthroplasty

Not Applicable

Recruiting

• Conditions: Carpometacarpal (CMC) Joint Arthritis

• Registration Number: NCT06876350
• Lead Sponsor: Foundation for Orthopaedic Research and Education

Brief Summary

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

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 Timeline

• Study Start: 2024-10-03
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction Score	6 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Waste	2 Weeks	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.
Splint Satisfaction	6 Weeks	Patient will have three questions totaling 15 with the higher score indicating highest satisfaction.
Splint Issues	6 Weeks	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.

Trial Locations

Locations (1)

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States