Clinical Trials Directory

Trials / Completed

CompletedNCT06430944

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Kasr El Aini Hospital · Academic / Other
Sex
All
Age
2 Years – 6 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPlacing a hip spica cast for patients with femur fracturesPlacing a hip spica cast for patients with femur fractures. These hip spicas are made for each patient to stabilize the fracture in pediatric patients

Timeline

Start date
2022-05-01
Primary completion
2024-01-30
Completion
2024-01-30
First posted
2024-05-28
Last updated
2024-05-28

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06430944. Inclusion in this directory is not an endorsement.