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)?

NCT07289256 | Not Yet Recruiting

• 1 other identifier: Spica cast and DDH
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

DDH

Outcome Measures

Primary Outcomes (1)

• Redislocation rate

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

  12 months post-surgery

Secondary Outcomes (3)

• Radiological outcomes

  3, 6, and 12 months post-surgery

• Functional outcomes

  Within 6-12 months post-surgery

• Complications

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

Study Arms (2)

6-week spica group

EXPERIMENTAL

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

12-week spica group

EXPERIMENTAL

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

Interventions

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.

6-week spica group

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.

12-week spica group

Eligibility Criteria

• Age: 18 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Infection
• Paralytic hip dislocation

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Model Details: 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)

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12