Woodcasting Versus Thermoplast Splint in CMC Arthroplasty

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06876350
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Foundation for Orthopaedic Research and Education
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Doarn, MD
Principal Investigator Affiliation Florida Orthopaedic Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Carpometacarpal (CMC) Joint Arthritis
Additional Details

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.

Arms & Interventions

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

Other: - Woodcasting Splint

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Florida Orthopaedic Institute, Tampa, Florida

Status

Recruiting

Address

Florida Orthopaedic Institute

Tampa, Florida, 33637

Site Contact

Andy Nguyen, BS

[email protected]

8139789700 #6837