Woodcasting Versus Thermoplast Splint in CMC Arthroplasty

NCT ID: NCT06876350

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-03

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Carpometacarpal (CMC) Joint Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Woodcasting Splint

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Control (Standard treatment)

Intervention Type 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.

Interventions

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Woodcasting Splint

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Orthopaedic Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Michael C. Doarn

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Doarn, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Orthopaedic Institute

Locations

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Florida Orthopaedic Institute

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andy Nguyen, BS

Role: CONTACT

8139789700 ext. 6837

Deborah Warren, RN

Role: CONTACT

8139789700

Facility Contacts

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Andy Nguyen, BS

Role: primary

8139789700 ext. 6837

Other Identifiers

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Study007574

Identifier Type: -

Identifier Source: org_study_id

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