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Completed

NCT Number: NCT01238523

Study 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

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Key information

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles Orthopaedic Hospital

Los Angeles, California, 90007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long leg cast in full extension

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

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Los Angeles Orthopaedic Hospital

Registry information

Official study title

Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 10, 2010
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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