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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06430944
Enrollment
84
Registered
2024-05-28
Start date
2022-05-01
Completion date
2024-01-30
Last updated
2024-05-28

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

Conditions

Femur Fracture

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.

Interventions

PROCEDUREPlacing 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

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Flynn's score6 monthsThe 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

MeasureTime frameDescription
loss of reduction6 monthswe do xrays to confirm if there is any loss of reduction of the fracture

Countries

Egypt

Outcome results

None listed

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