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

Study Overview

• Status: Completed
• Conditions: Tibial Shaft Fractures in Children
• Intervention / Treatment: Procedure: Long leg cast in full extension; Procedure: Long leg cast with 45 degrees of flexion

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90007
      • Los Angeles Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	May 2007 - May 2010

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	May 2007 - May 2010

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Los Angeles Orthopaedic Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: November 9, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 10, 2010

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: children; fracture; tibia; shaft
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: OH-001