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

NCT06430944 | Completed

• 1 other identifier: MS-318-2023
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Femur Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• loss of reduction

  6 months

Study Arms (2)

Single limb spica casting:

EXPERIMENTAL

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.

Procedure: Placing a hip spica cast for patients with femur fractures

Double limb spica cast:

ACTIVE COMPARATOR

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

Procedure: Placing a hip spica cast for patients with femur fractures

Interventions

Placing a hip spica cast for patients with femur fractures 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:; Single limb spica casting:

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 2 to 6 years
• Children with femur shaft fractures

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Ainy-Cairo University- Faculty of Medicine

Cairo, Manial, 11956, Egypt

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: May 1, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

EG (1)