Study of Tibial Shaft Fractures in Children
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ClinicalTrials.gov Identifier: NCT01238523 |
Recruitment Status
:
Completed
First Posted
: November 10, 2010
Last Update Posted
: August 17, 2017
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Tibial Shaft Fractures in Children | Procedure: Long leg cast in full extension Procedure: Long leg cast with 45 degrees of flexion | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 81 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
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
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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
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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
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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
|
- The Activities Scale for Kids - Performance (ASK-P) [ Time Frame: May 2007 - May 2010 ]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 to Healing [ Time Frame: May 2007 - May 2010 ]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.

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Ages Eligible for Study: | 4 Years to 14 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238523
United States, California | |
Los Angeles Orthopaedic Hospital | |
Los Angeles, California, United States, 90007 |
Publications of Results:
Responsible Party: | Mauricio Silva, Principal Investigator, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT01238523 History of Changes |
Other Study ID Numbers: |
OH-001 |
First Posted: | November 10, 2010 Key Record Dates |
Last Update Posted: | August 17, 2017 |
Last Verified: | May 2010 |
Keywords provided by Mauricio Silva, University of California, Los Angeles:
tibia shaft fracture children |
Additional relevant MeSH terms:
Fractures, Bone Wounds and Injuries Calpastatin Cysteine Proteinase Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |