DDHNCT07289256
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)?
A study testing hip spica immobilization for 6 weeks and hip spica immobilization for 12 weeks in people with DDH, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- DDH
- What is being tested?
- hip spica immobilization for 6 weeks and hip spica immobilization for 12 weeks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 18 months-6 years undergoing open reduction with pelvic osteotomy for DDH.
Who cannot join
- • Infection
- Paralytic hip dislocation
About this study
Official title: 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.
Read the 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
- DDH
- Being tested
- hip spica immobilization for 6 weeks, hip spica immobilization for 12 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip spica immobilization for 6 weeksProcedure or surgery
Patients undergo open reduction and pelvic osteotomy for DDH followed by hip spica cast immobilization for 6 weeks.
hip spica immobilization for 12 weeksProcedure or surgery
Patients undergo open reduction and pelvic osteotomy for DDH followed by hip spica cast immobilization for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: hip spica immobilization for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Redislocation rate
Incidence of hip redislocation within the first 12 months after open reduction and hip spica immobilization.
Measured: 12 months post-surgery
Secondary outcomes (3)
Radiological outcomes
Assessment of acetabular index and femoral head position using pelvic X-rays at follow-up
Measured: 3, 6, and 12 months post-surgery
Functional outcomes
Time to independent ambulation and hip joint range of motion assessment.
Measured: Within 6-12 months post-surgery
Complications
Occurrence of cast-related problems including skin sores, pressure ulcers, and cast intolerance.
Measured: During immobilization period and up to 3 months post-cast removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DDHStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makarious Medhat Mahfouz Ishak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289256
- Sponsor's protocol ID
- Spica cast and DDH
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hip Spica Duration (6 Weeks vs 12 Weeks) Following Open Reduction and Pelvic Osteotomy in Developmental Dysplasia of the Hip
- ClinicalTrials.gov ID
- NCT07289256
- Acronym / sponsor ID
- Spica cast and DDH
- Conditions
- DDH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| 6-week spica group | Experimental | Procedure: hip spica immobilization for 6 weeksPatients will undergo open reduction and pelvic osteotomy for DDH, followed by immobilization in a hip spica cast for 6 weeks. |
| 12-week spica group | Experimental | Procedure: hip spica immobilization for 12 weeksPatients will undergo open reduction and pelvic osteotomy for DDH, followed by immobilization in a hip spica cast for 12 weeks. |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 18 months-6 years undergoing open reduction with pelvic osteotomy for DDH.
Key exclusion criteria (2 listed)
- • Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hip spica immobilization for 6 weeksPatients undergo open reduction and pelvic osteotomy for DDH followed by hip spica cast immobilization for 6 weeks. | Procedure or surgery | 6-week spica group |
| hip spica immobilization for 12 weeksPatients undergo open reduction and pelvic osteotomy for DDH followed by hip spica cast immobilization for 12 weeks. | Procedure or surgery | 12-week spica group |
Primary outcome
Redislocation rate
Time frame: 12 months post-surgery
Incidence of hip redislocation within the first 12 months after open reduction and hip spica immobilization.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Computer-Assisted Comparison of Hip Socket Volume and Surface Shape After Pediatric Acetabular Osteotomies
Developmental Dysplasia of the Hip (DDH), Developmental Dysplasia of the Hip
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing hip spica immobilization for 6 weeks and hip spica immobilization for 12 weeks in people with DDH, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Redislocation rate (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.