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

November 9, 2010
November 9, 2010
May 2007
May 2010   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Study of Tibial Shaft Fractures in Children
Early Weight-Bearing in the Closed Treatment 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 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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tibial Shaft Fractures in Children
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
4 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01238523
OH-001
Yes
Dr. Mauricio Silva, Los Angeles Orthopaedic Hospital
University of California, Los Angeles
Los Angeles Orthopaedic Hospital
Not Provided
University of California, Los Angeles
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP