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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07289256

Enrollment

Registered

2025-12-17

Start date

2026-01-01

Completion date

2027-03-01

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DDH

Brief 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.

Interventions

PROCEDUREhip spica immobilization for 6 weeks

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

PROCEDUREhip spica immobilization for 12 weeks

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Participants will be randomized into two parallel groups to receive either 6 weeks or 12 weeks of hip spica immobilization following open reduction for developmental dysplasia of the hip (DDH)

Eligibility

Sex/Gender

ALL

Age

18 Months to 6 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* • Infection * Paralytic hip dislocation

Design outcomes

Primary

Measure	Time frame	Description
Redislocation rate	12 months post-surgery	Incidence of hip redislocation within the first 12 months after open reduction and hip spica immobilization.

Secondary

Measure	Time frame	Description
Functional outcomes	Within 6-12 months post-surgery	Time to independent ambulation and hip joint range of motion assessment.
Radiological outcomes	3, 6, and 12 months post-surgery	Assessment of acetabular index and femoral head position using pelvic X-rays at follow-up
Complications	During immobilization period and up to 3 months post-cast removal	Occurrence of cast-related problems including skin sores, pressure ulcers, and cast intolerance.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026