Woodcasting Versus Thermoplast Splint in CMC Arthroplasty

Part of paid clinical trials in Tampa, Florida.

Sponsor
Foundation for Orthopaedic Research and Education
Study ID
NCT06876350
Status
Recruiting
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Conditions

  • Carpometacarpal (CMC) Joint Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Oct 3, 2024
Status verified
Mar 2025
Primary completion
May 31, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Patient Satisfaction Score [ Time Frame: 6 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida Orthopaedic InstituteTampaFlorida33637
Andy Nguyen, BS
[email protected]
8139789700
Michael Doarn, MD (PRINCIPAL_INVESTIGATOR)
Alfred Hess, MD (SUB_INVESTIGATOR)
Ronald Mitchell, MD (SUB_INVESTIGATOR)

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Florida Orthopaedic Institute· Tampa, FL