Woodcasting Splint for Thumb Arthritis

(Woodcast Trial)

Overseen By Deborah Warren, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foundation for Orthopaedic Research and Education

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

26 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Michael Doarn, MD

Principal Investigator

Florida Orthopaedic Institute

Eligibility Criteria

This trial is for adults over 18 with thumb arthritis who can make medical decisions and are eligible for surgery. They must be willing to follow the treatment and check-up plan for 6 weeks. Pregnant women or those considered unsuitable by the lead researcher cannot join.

Inclusion Criteria

I am capable of making my own healthcare decisions.

I am fit for surgery.

Willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks

Exclusion Criteria

Pregnant Women

Deemed Unsuitable by Principal Investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo carpometacarpal arthroplasty and are randomized into either the woodcast or thermoplast splint group

6 weeks

Regular follow-up visits as per standard post-operative care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient satisfaction and splint issues

6 weeks

Treatment Details

Interventions

• Woodcasting Splint

Trial Overview The study compares patient preferences between two types of splints after thumb joint surgery: a standard treatment (control) versus a woodcasting splint. It's set up so patients are randomly chosen to receive one or the other, but they'll know which one they get.

Participant Groups

Group I: Woodcasting Splint Experimental Treatment 1 Intervention

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.

Group II: Thermoplastic Splint Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Foundation for Orthopaedic Research and Education

Lead Sponsor

Trials

16

Recruited

1,000+