Study of Tibial Shaft Fractures in Children
Primary Purpose
Tibial Shaft Fractures in Children
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Long leg cast in full extension
Long leg cast with 45 degrees of flexion
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Shaft Fractures in Children focused on measuring tibia, shaft, fracture, children
Eligibility 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
Sites / Locations
- Los Angeles Orthopaedic Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Long leg cast in full extension
Long leg cast with 45 degrees of flexion
Arm Description
Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity
Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity
Outcomes
Primary Outcome Measures
The Activities Scale for Kids - Performance (ASK-P)
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
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.
Full Information
NCT ID
NCT01238523
First Posted
November 9, 2010
Last Updated
August 14, 2017
Sponsor
University of California, Los Angeles
Collaborators
Los Angeles Orthopaedic Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01238523
Brief Title
Study of Tibial Shaft Fractures in Children
Official Title
Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Los Angeles Orthopaedic Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Shaft Fractures in Children
Keywords
tibia, shaft, fracture, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Long leg cast in full extension
Arm Type
Experimental
Arm Description
Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity
Arm Title
Long leg cast with 45 degrees of flexion
Arm Type
Experimental
Arm Description
Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity
Intervention Type
Procedure
Intervention Name(s)
Long leg cast in full extension
Intervention Description
Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity
Intervention Type
Procedure
Intervention Name(s)
Long leg cast with 45 degrees of flexion
Intervention Description
Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity
Primary Outcome Measure Information:
Title
The Activities Scale for Kids - Performance (ASK-P)
Description
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.
Time Frame
May 2007 - May 2010
Secondary Outcome Measure Information:
Title
Time to Healing
Description
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.
Time Frame
May 2007 - May 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Los Angeles Orthopaedic Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23079877
Citation
Silva M, Eagan MJ, Wong MA, Dichter DH, Ebramzadeh E, Zionts LE. A comparison of two approaches for the closed treatment of low-energy tibial fractures in children. J Bone Joint Surg Am. 2012 Oct 17;94(20):1853-60. doi: 10.2106/JBJS.J.01728.
Results Reference
result
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Study of Tibial Shaft Fractures in Children
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