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)?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hip spica immobilization for 6 weeks, hip spica immobilization for 12 weeks.
- Who it may be relevant to
- Registry conditions: DDH. Basic parameters: 18 months — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Hip Spica Duration (6 Weeks vs 12 Weeks) Following Open Reduction and Pelvic Osteotomy in Developmental Dysplasia of the Hip
Overview
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.
Interventions
- Procedure hip spica immobilization for 6 weeks
Patients undergo open reduction and pelvic osteotomy for DDH followed by hip spica cast immobilization for 6 weeks. - Procedure hip spica immobilization for 12 weeks
Patients undergo open reduction and pelvic osteotomy for DDH followed by hip spica cast immobilization for 12 weeks.
Primary outcome measures
- Redislocation rate [Time frame: 12 months post-surgery]
Secondary outcome measures (3)
- Radiological outcomes [Time frame: 3, 6, and 12 months post-surgery]
- Functional outcomes [Time frame: Within 6-12 months post-surgery]
- Complications [Time frame: During immobilization period and up to 3 months post-cast removal]
Eligibility criteria
Inclusion criteria
- Children 18 months-6 years undergoing open reduction with pelvic osteotomy for DDH.
Exclusion criteria
- • Infection
- Paralytic hip dislocation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07289256 · Spica cast and DDH