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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: DDH
• Intervention / Treatment: Procedure: hip spica immobilization for 6 weeks; Procedure: hip spica immobilization for 12 weeks

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• • Infection

  • Paralytic hip dislocation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6-week spica group; Patients will undergo open reduction and pelvic osteotomy for DDH, followed by immobilization in a hip spica cast for 6 weeks.	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.
Experimental: 12-week spica group; Patients will undergo open reduction and pelvic osteotomy for DDH, followed by immobilization in a hip spica cast for 12 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Spica cast and DDH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No