Study of Tibial Shaft Fractures in Children

NCT ID: NCT01238523

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-05-31

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

Conditions

Tibial Shaft Fractures in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Long leg cast in full extension

Intervention Type: PROCEDURE

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

Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity

Group Type: EXPERIMENTAL

Long leg cast with 45 degrees of flexion

Intervention Type: PROCEDURE

Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Los Angeles Orthopaedic Hospital

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Mauricio Silva

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Los Angeles Orthopaedic Hospital

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23079877 (View on PubMed)

Other Identifiers

OH-001

Identifier Type: -

Identifier Source: org_study_id