Study of Tibial Shaft Fractures in Children

This study has been completed.

Sponsor:

Collaborator:

Los Angeles Orthopaedic Hospital

Information provided by:

University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT01238523

First received: November 9, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	November 9, 2010
Last Updated Date	November 9, 2010
Start Date ^ICMJE	May 2007
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 9, 2010)	The Activities Scale for Kids - Performance (ASK-P) [ Time Frame: May 2007 - May 2010 ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: November 9, 2010)	Time to Healing [ Time Frame: May 2007 - May 2010 ] [ Designated as safety issue: No ] Radiographic union will be defined as the presence of callus bridging of 3 out of 4 cortices as seen on anterior posterior and lateral radiographs.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Tibial Shaft Fractures in Children
Official Title ^ICMJE	Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children
Brief 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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Tibial Shaft Fractures in Children
Intervention ^ICMJE	Procedure: Long leg cast in full extension Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity Procedure: Long leg cast with 45 degrees of flexion Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity
Study Arm (s)	Experimental: Long leg cast in full extension Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity Intervention: Procedure: Long leg cast in full extension Experimental: Long leg cast with 45 degrees of flexion Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity Intervention: Procedure: Long leg cast with 45 degrees of flexion
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	81
Completion Date	May 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients between 4 and 14 years of age (open physis) Patients seen at the Los Angeles Orthopaedic Medical center within 7 days of the original injury All closed tibia and tibia and fibula shaft fractures regardless of fracture pattern Exclusion Criteria: Fractures with greater than 2 cm of initial shortening Open fractures Patients that have other orthopaedic medical issues such as hemophilia
Gender	Both
Ages	4 Years to 14 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01238523
Other Study ID Numbers ^ICMJE	OH-001
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Mauricio Silva, Los Angeles Orthopaedic Hospital
Study Sponsor ^ICMJE	University of California, Los Angeles
Collaborators ^ICMJE	Los Angeles Orthopaedic Hospital
Investigators ^ICMJE	Not Provided
Information Provided By	University of California, Los Angeles
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top