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Not Yet RecruitingNCT07289256

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)?

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Months – 6 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREhip spica immobilization for 6 weeksPatients undergo open reduction and pelvic osteotomy for DDH followed by hip spica cast immobilization for 6 weeks.
PROCEDUREhip spica immobilization for 12 weeksPatients undergo open reduction and pelvic osteotomy for DDH followed by hip spica cast immobilization for 12 weeks.

Timeline

Start date
2026-01-01
Primary completion
2027-01-01
Completion
2027-03-01
First posted
2025-12-17
Last updated
2025-12-17

Source: ClinicalTrials.gov record NCT07289256. Inclusion in this directory is not an endorsement.