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

NCT ID: NCT06430944

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-01-30

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.

Conditions

Femur Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single limb spica casting:

A folded towel was placed inside the tubular bandage over the centre of the abdomen, which helped create breathing space inside the cast. The towel's tail was brought towards the neck for easier removal.

Then, a layer of the padded cast was applied using a large width for the body and a narrower one for the lower limb. A thick felt was added over this padding along the free edges of the chest and the leg. The first layer of the cast was applied to the leg and body in an eight-figure manner, taking care to connect the leg to the body securely. The reinforced cast slabs were applied between the body and the lower limb segments. The thigh segment was moulded to maintain a good reduction by keeping the anterolateral of the cast flat or slightly concave. Some clinicians moulded the segment enough to result in ten degrees of initial valgus.

Group Type: EXPERIMENTAL

Placing a hip spica cast for patients with femur fractures

Intervention Type: PROCEDURE

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

Double limb spica cast:

One and a half cast was applied in a single limb spica cast, extending to the opposite leg to the knee. Reinforced slabs were applied to hip joints in both limbs

Group Type: ACTIVE_COMPARATOR

Placing a hip spica cast for patients with femur fractures

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Omar Sabry

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Al Ainy-Cairo University- Faculty of Medicine

Cairo, Manial, Egypt

Countries

Egypt

Other Identifiers

MS-318-2023

Identifier Type: -

Identifier Source: org_study_id