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NCT01926795 · ClinicalTrials.gov registry record · NA
Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
A NA study of Tibial Fractures, sponsored by Prisma Health-Upstate.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01926795 is a NA study of Tibial Fractures that has completed, run by Prisma Health-Upstate. The registered enrollment target is 21 participants, below the 338-participant average among 12 other Tibial Fractures trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01926795, a NA study of Tibial Fractures, has completed, sponsored by Prisma Health-Upstate.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing \& bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups.
Conditions Studied
Interventions
- PROCEDURE Short leg cast
- PROCEDURE No Immobilization
Study Locations (1)
South Carolina
- Greenville Hospital System - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01926795
The ClinicalTrials.gov registry entry for NCT01926795 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 338-participant average among 12 other Tibial Fractures trials with a reported enrollment target (94% lower). The listed sponsor is Prisma Health-Upstate, which has 67 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tibial Fractures appearing as the primary indexed condition, and to 2 interventions - of which Short leg cast is the first listed.
NCT01926795 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT01926795 about?
NCT01926795 is a clinical study titled "Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial". Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not ...
What is the current status of trial NCT01926795?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2013-06. Estimated completion is 2015-02.
What conditions does trial NCT01926795 study?
This clinical trial studies the following conditions: Tibial Fractures.
What interventions are being tested in trial NCT01926795?
The interventions under investigation include: Short leg cast (PROCEDURE), No Immobilization (PROCEDURE).
Who is sponsoring clinical trial NCT01926795?
This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01926795 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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