Study of Tibial Shaft Fractures in Children

This study has been completed.

Sponsor:

Collaborator:

Los Angeles Orthopaedic Hospital

Information provided by (Responsible Party):

Mauricio Silva, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT01238523

First received: November 9, 2010

Last updated: August 14, 2017

Last verified: May 2010

History of Changes

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: None (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:

MedlinePlus related topics: Fractures

U.S. FDA Resources

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

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


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)
Sexes Eligible for Study:	All
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

Publications:

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.


Responsible Party:	Mauricio Silva, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT01238523 History of Changes
Other Study ID Numbers:	OH-001
Study First Received:	November 9, 2010
Last Updated:	August 14, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017

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