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NCT Number: NCT07289256

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)?

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.

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Key information

Conditions

DDH

Age range

18 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • Infection
  • Paralytic hip dislocation

Treatment and study plan

hip spica immobilization for 6 weeks

Procedure

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

hip spica immobilization for 12 weeks

Procedure

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

Primary outcomes

  1. Redislocation rate

    Time frame: 12 months post-surgery

    Incidence of hip redislocation within the first 12 months after open reduction and hip spica immobilization.

Secondary outcomes

  1. Radiological outcomes

    Time frame: 3, 6, and 12 months post-surgery

    Assessment of acetabular index and femoral head position using pelvic X-rays at follow-up

  2. Functional outcomes

    Time frame: Within 6-12 months post-surgery

    Time to independent ambulation and hip joint range of motion assessment.

  3. Complications

    Time frame: During immobilization period and up to 3 months post-cast removal

    Occurrence of cast-related problems including skin sores, pressure ulcers, and cast intolerance.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparison of Hip Spica Duration (6 Weeks vs 12 Weeks) Following Open Reduction and Pelvic Osteotomy in Developmental Dysplasia of the Hip

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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