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

Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06430944
• Other study ID #: MS-318-2023
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: May 2024
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Procedure:
• Placing a hip spica cast for patients with femur fractures
Placing a hip spica cast for patients with femur fractures. These hip spicas are made for each patient to stabilize the fracture in pediatric patients

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy-Cairo University- Faculty of Medicine	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flynn's score	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.	6 months
Secondary	loss of reduction	we do xrays to confirm if there is any loss of reduction of the fracture	6 months