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Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children

Not Applicable
Completed
Conditions
Femur Fracture
Registration Number
NCT06430944
Lead Sponsor
Kasr El Aini Hospital
Brief Summary

We performed a randomized control trial including 84 children aged two to six years who presented with femoral fractures. They were randomized into two groups; the first was managed by single limb cast fixation (42 patients), and the second was managed by double limb cast fixation (42 patients). The primary outcomes were postprocedural functional outcomes and parents' satisfaction, while the secondary outcomes were the rates of complications.

Detailed Description

Femoral fractures are frequent in children and compose 1% to 2% of all pediatric fractures. Conservative management is associated with good results, whether by single or double-limb cast fixations. We aim to compare both procedures regarding functional outcomes, complications, and parents' satisfaction. Eighty-four children were eligible to be included in our study; 42 underwent single limb spica casts, and the other 42 patients underwent double limb spica casts. Both groups had similar baseline characteristics like age, gender, fracture side, and fracture classification.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
84
Inclusion Criteria
  • children aged 2 to 6 years
  • Children with femur shaft fractures
Exclusion Criteria
  • Children younger than 2 years or older than 6 years
  • Articular fractures or fractures that cant be managed with a cast
  • Old fractures older than 3 weeks

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Flynn's score6 months

The Flynn evaluation system is based on the presence of leg length inequality, malalignment, pain, and minor and major complications. Each of these criteria is either defined as Excellent, successful or poor.

Secondary Outcome Measures
NameTimeMethod
loss of reduction6 months

we do xrays to confirm if there is any loss of reduction of the fracture

Trial Locations

Locations (1)

Kasr Al Ainy-Cairo University- Faculty of Medicine

🇪🇬

Cairo, Manial, Egypt

Kasr Al Ainy-Cairo University- Faculty of Medicine
🇪🇬Cairo, Manial, Egypt

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