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Woodcasting Versus Thermoplast Splint in CMC Arthroplasty

F

Foundation for Orthopaedic Research and Education

Status

Enrolling

Conditions

Carpometacarpal (CMC) Joint Arthritis

Treatments

Other: Control (Standard treatment)
Other: Woodcasting Splint

Study type

Interventional

Funder types

Other

Identifiers

NCT06876350
Study007574

Details and patient eligibility

About

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

Full description

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.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Woodcasting Splint
Experimental group
Description:
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.
Treatment:
Other: Woodcasting Splint
Thermoplastic Splint
Active Comparator group
Description:
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.
Treatment:
Other: Control (Standard treatment)

Trial contacts and locations

1

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Central trial contact

Deborah Warren, RN; Andy Nguyen, BS

Data sourced from clinicaltrials.gov

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