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

K

Kasr El Aini Hospital

Status

Completed

Conditions

Femur Fracture

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06430944
MS-318-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

Single limb spica casting:
Experimental group
Description:
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.
Treatment:
Procedure: Placing a hip spica cast for patients with femur fractures
Double limb spica cast:
Active Comparator group
Description:
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
Treatment:
Procedure: Placing a hip spica cast for patients with femur fractures

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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