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NCT01238523 · ClinicalTrials.gov registry record · NA
Study of Tibial Shaft Fractures in Children
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 81
- Enrollment target
NCT01238523 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 81 participants.
The verdict
NCT01238523, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
Study Summary
Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. While most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5). The purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion As well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study
Interventions
- PROCEDURE Long leg cast in full extension
- PROCEDURE Long leg cast with 45 degrees of flexion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01238523
The ClinicalTrials.gov registry entry for NCT01238523 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 81 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 0 conditions, and to 2 interventions - of which Long leg cast in full extension is the first listed.
NCT01238523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01238523 about?
NCT01238523 is a clinical study titled "Study of Tibial Shaft Fractures in Children". Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures a...
What is the current status of trial NCT01238523?
This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2007-05. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01238523?
The interventions under investigation include: Long leg cast in full extension (PROCEDURE), Long leg cast with 45 degrees of flexion (PROCEDURE).
Who is sponsoring clinical trial NCT01238523?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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