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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

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

Name	Time	Method
Flynn's score	6 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

Name	Time	Method
loss of reduction	6 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