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This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Woodcasting Splint | Experimental | 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. |
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| Thermoplastic Splint | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Woodcasting Splint | Other | This is the experimental group so we could see the outcomes and preference for patients using surveys and compliance scores |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 Weeks |
| Splint Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andy Nguyen, BS | Contact | 8139789700 | 6837 | anguyen@foreonline.org |
| Deborah Warren, RN | Contact | 8139789700 | dwarren@foreonline.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Doarn, MD | Florida Orthopaedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Orthopaedic Institute | Recruiting | Tampa | Florida | 33637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41656908 | Derived | Nguyen T, Hung VT, Hancock JU, Bailey D, Hess AV, Doarn M. Evaluating Patient Compliance With Woodcast and Thermoplast Splints After Thumb Carpometacarpal Arthroplasty: A Randomized Controlled Trial. Hand (N Y). 2026 Feb 8:15589447251415394. doi: 10.1177/15589447251415394. Online ahead of print. |
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Each participant data will be grouped for each cohort and averaged, so individual participant data is not necessary to perform a data analysis of the study.
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| ID | Term |
|---|---|
| C562760 | Capillary Malformations, Congenital, 1 |
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| 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. |
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Patient will have three questions totaling 15 with the higher score indicating highest satisfaction.
| 6 Weeks |
| 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. | 6 Weeks |