Tibial Shaft Fractures in Children Clinical Trial
Official title:
Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children
| Verified date | May 2010 |
| Source | University of California, Los Angeles |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 81 |
| Est. completion date | May 2010 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 4 Years to 14 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Los Angeles Orthopaedic Hospital | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Los Angeles | Los Angeles Orthopaedic Hospital |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |