Does a 6-week Duration of Hip Spica Immobilization Provide Comparable Clinical and Radiological Outcomes to 12 Weeks in Children Undergoing Open Reduction and Pelvic Osteotomy for Developmental Dysplasia of the Hip (DDH)?

Assiut University

Status: Not yet enrolling

Conditions: DDH

Treatments: Procedure: hip spica immobilization for 12 weeks; Procedure: hip spica immobilization for 6 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT07289256

Spica cast and DDH

Details and patient eligibility

About

The study aim is to compare clinical and radiological outcomes of 6-week versus 12-week hip spica immobilization following open reduction and pelvic osteotomy for DDH.

Full description

Developmental dysplasia of the hip (DDH) is a common pediatric orthopedic disorder with a prevalence of 2% to 3% in neonates. Surgical intervention, including open reduction and pelvic osteotomy, is indicated when closed reduction fails or diagnosis is delayed. Traditionally, postoperative immobilization in a hip spica cast is recommended for 12 weeks to maintain stability. However, recent studies suggest that shorter durations (6 weeks) may provide equivalent stability with fewer complications such as joint stiffness, muscle atrophy, skin breakdown, and caregiver burden. some fractures occurs after the cast, according to Alassaf 2018 out of total of 128 patients (162 hips) 93 were in the double-leg spica group, and 69 were in the single-leg spica group three patients had a greenstick distal femur fracture after double-leg spica and one after single-leg spica. There is no international consensus on the optimal spica duration, and evidence is limited. Proving that 6 weeks immobilization is not inferior to 12 weeks immobilization could improve outcomes, reduce costs, and lessen morbidity.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 months to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children 18 months-6 years undergoing open reduction with pelvic osteotomy for DDH.

Exclusion criteria

• • Infection

  • Paralytic hip dislocation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

6-week spica group

Experimental group

Description:

Patients will undergo open reduction and pelvic osteotomy for DDH, followed by immobilization in a hip spica cast for 6 weeks.

Treatment:

Procedure: hip spica immobilization for 6 weeks

12-week spica group

Experimental group

Description:

Patients will undergo open reduction and pelvic osteotomy for DDH, followed by immobilization in a hip spica cast for 12 weeks.

Treatment:

Procedure: hip spica immobilization for 12 weeks