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Study of Tibial Shaft Fractures in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01238523
Enrollment
81
Registered
2010-11-10
Start date
2007-05-31
Completion date
2010-05-31
Last updated
2017-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial Shaft Fractures in Children

Keywords

tibia, shaft, fracture, children

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

Interventions

PROCEDURELong leg cast in full extension

Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity

PROCEDURELong 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

Sponsors

Los Angeles Orthopaedic Hospital
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Activities Scale for Kids - Performance (ASK-P)May 2007 - May 2010The 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

MeasureTime frameDescription
Time to HealingMay 2007 - May 2010Radiographic union will be defined as the presence of callus bridging of 3 out of 4 cortices as seen on anterior posterior and lateral radiographs.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026