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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: Completed NA study, sponsored by University of California, Los Angeles.
NCT01238523 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 81 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The Activities Scale for Kids (ASK) is a 30 item child self-report musculoskeletal outcome measure that focuses on the child's physical disability, and is scored with a summary score with no sub-scales. The performance format ASK-P will be used in this study. The scoring system is from 0-100 with 100 being the best possible score.
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 |
What the finished NCT01238523 record still lists
NCT01238523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Long leg cast in full extension is the first listed.
NCT01238523 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01238523's enrollment target sits among peer trials
81 992nd of 2000 higher than 1,007 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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