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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
  Purpose

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


Condition Intervention
Tibial Shaft Fractures in Children
 Procedure: Long leg cast in full extension
Procedure: Long leg cast with 45 degrees of flexion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
Enrollment: 81
Study Start Date: May 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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
 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

  Eligibility
Ages Eligible for Study:   4 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238523

Locations
United States, California
Los Angeles Orthopaedic Hospital
Los Angeles, California, United States, 90007
Sponsors and Collaborators
University of California, Los Angeles
Los Angeles Orthopaedic Hospital
  More Information

Responsible Party: Dr. Mauricio Silva, Los Angeles Orthopaedic Hospital
ClinicalTrials.gov Identifier: NCT01238523     History of Changes
Other Study ID Numbers: OH-001 
Study First Received: November 9, 2010
Last Updated: November 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
tibia
shaft
fracture
children

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 28, 2016