Pediatric Femur Research Project

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00943332

Enrollment

Registered

2009-07-22

Start date

2009-06-30

Completion date

2018-01-31

Last updated

2019-04-26

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

Conditions

Femur Fracture

Keywords

Orthopedic Procedures, Fracture Fixation, Internal, Fracture Fixation, External, femur fracture, pediatrics

Brief summary

Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting for patients 6 years and younger and for patients over 6 years and older is percutaneous or open placement of titanium elastic intramedullary nails. The investigators would like to evaluate the current treatment protocol by comparing those patients 6 years and younger treated with closed reduction and spica casting to those 6 years and younger treated with percutaneous pinned with titanium elastic intramedullary nails or submuscular plating. The investigators will be comparing their post-operative functional level, pain management, impact on family and complications through chart and x-ray reviews. The goal is to improve patient care pre and post-operatively for those who have sustained a femoral shaft fracture 6 years old and younger and increase the knowledge of those residents/physicians who care for this patient population.

Interventions

PROCEDUREfemur fracture repair

all participants will have undergone surgical intervention to repair a femur fracture, the investigators will simply be collecting data after the procedure; participants will not be consented until after the procedure

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Yes

Inclusion criteria

* Child diagnosed with femur fracture between the ages of 2-6 years old * Patient will undergo surgical intervention for a femur fracture (e.g., submuscular plating, Nancy nailing, casting )

Exclusion criteria

* Parent refusal to participate for any reason * Children with neuromuscular disorders having a Gross Motor Function Classification greater than 3 * Pathologic fracture

Design outcomes

Primary

Measure	Time frame
Impact on family	6 months

Secondary

Measure	Time frame
post-operative functional level	1 year
pain management	6 weeks
complications	2 years

Countries

United States

Outcome results

None listed

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