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NCT Number: NCT06876350

Woodcasting Versus Thermoplast Splint in CMC Arthroplasty

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

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Key information

Conditions

Carpometacarpal (CMC) Joint Arthritis Capillary Malformations, Congenital, 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

Location status: Recruiting

Location contact

Alfred Hess, MD

SUB_INVESTIGATOR

Andy Nguyen, BS

CONTACT

[email protected]

8139789700 ext. 6837

Michael Doarn, MD

PRINCIPAL_INVESTIGATOR

Ronald Mitchell, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Woodcasting Splint

Other

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

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.

Primary outcomes

  1. Patient Satisfaction Score

    Time frame: 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 outcomes

  1. Waste

    Time frame: 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.

  2. Splint Satisfaction

    Time frame: 6 Weeks

    Patient will have three questions totaling 15 with the higher score indicating highest satisfaction.

  3. Splint Issues

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andy Nguyen, BS

CONTACT

[email protected]

8139789700 ext. 6837

Deborah Warren, RN

CONTACT

[email protected]

8139789700

Sponsors and collaborators

Lead sponsor

Foundation for Orthopaedic Research and Education

Other

Registry information

Official study title

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

Acronym: Woodcast

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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