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NCT02095106 · ClinicalTrials.gov registry record · NA
Waterproof Casting for Pediatric Distal Radius Fractures
A NA study of Pediatric Distal Radius Fractures, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT02095106 is a NA study of Pediatric Distal Radius Fractures that has completed, run by University of California, Los Angeles. The registered enrollment target is 27 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02095106, a NA study of Pediatric Distal Radius Fractures, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
Distal radius fractures are one of the most commonly seen fractures in children. Traditionally, minimally angulated or non-displaced distal radius fractures are treated with short or long-arm cast immobilization for up to 8 weeks. The traditional fiberglass casts used must be kept dry to prevent inflammation and potential infection. If a fiberglass cast gets wet, it must be removed and replaced. In general, waterproof casting has been shown to improve patient comfort and overall satisfaction. We intend to explore the efficacy of a new, waterproof cast made of a hybrid mesh in the treatment of minimally angulated distal radius fractures in children using a randomized, controlled, cross-over study design. We will include patients between 4 and 14 years of age with minimally angulated distal radius fractures (\<15 degrees of angulation on sagittal or coronal planes) presented to the Orthopaedic Institute for Children Urgent Care Facility within 7 days of injury. As determined by a power analysis, a total of 26 patients will be enrolled in the study. Patients eligible for the study will be randomized into one of two equally sized (n=13) groups: patients in Group 1 will receive a short arm cast made of the waterproof hybrid mesh material and patients in Group 2 will receive a regular fiberglass cast. Both groups will follow-up at two weeks for clinical and radiological evaluation, after which they will be transitioned into a regular fiberglass cast (Group 1) or a hybrid mesh waterproof cast (Group 2) for an additional two weeks. This crossover will allow both groups to experience each type of cast. After four weeks of immobilization, patients in both groups will discontinue casting and be advised to avoid contact sports or strenuous activities until week 8. Patients in both groups will follow up 8 weeks after initial treatment for clinical and radiological evaluation to evaluate range of motion, pain, and fracture alignment. Physical function will be evaluated at week
Conditions Studied
Interventions
- DEVICE Waterproof Cast
- DEVICE Traditional cast
Study Locations (1)
California
- Orthopaedic Institute for Children - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02095106
The ClinicalTrials.gov registry entry for NCT02095106 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pediatric Distal Radius Fractures appearing as the primary indexed condition, and to 2 interventions - of which Waterproof Cast is the first listed.
NCT02095106 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02095106 about?
NCT02095106 is a clinical study titled "Waterproof Casting for Pediatric Distal Radius Fractures". Distal radius fractures are one of the most commonly seen fractures in children. Traditionally, minimally angulated or non-displaced distal radius fractures are treated with short or long-arm cast immobilization for up to 8 weeks. The traditional fiberglass casts used must be kept dry to prevent inf...
What is the current status of trial NCT02095106?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2014-04. Estimated completion is 2015-10.
What conditions does trial NCT02095106 study?
This clinical trial studies the following conditions: Pediatric Distal Radius Fractures.
What interventions are being tested in trial NCT02095106?
The interventions under investigation include: Waterproof Cast (DEVICE), Traditional cast (DEVICE).
Who is sponsoring clinical trial NCT02095106?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02095106 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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