Woodcasting Versus Thermoplast Splint in CMC Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFoundation for Orthopaedic Research and Education

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant Women

Deemed Unsuitable by Principal Investigator

Trial design

Design model

Parallel

Treatments tested in this trial

  • Woodcasting Splint

    Other intervention

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

  • Control (Standard treatment)

    Other intervention

    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.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Woodcasting SplintExperimental treatment 1 intervention
Group B: Thermoplastic SplintActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient Satisfaction Score

The satisfaction survey consists of three questions totaling 15. The minimum value is a 1, while the maximum value is 15. A higher score indicating highest satisfaction.

Time frame
6 Weeks

Secondary outcomes

1

Waste

Each splint group creates waste for the fabrication and molding for each patient which will be recorded by the clinical research coordinator and weighed out.

Time frame
2 Weeks
2

Splint Satisfaction

Patient will have three questions totaling 15 with the higher score indicating highest satisfaction.

Time frame
6 Weeks
3

Splint Issues

A single question will be filled out by patients on a scale of 1-5 with a score of 5 indicating a lot of issues with their splint.

Time frame
6 Weeks

Other outcomes

Sponsors and contacts

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