Compare how four pelvic osteotomy techniques change the hip socket shape in children and teens with DDH
Computer-Assisted Comparative Analysis of Acetabular Volume and Surface Morphology in Pediatric Acetabular Osteotomies (Salter, Dega, San Diego, and Pemberton)
Istanbul University · NCT07581717
This project tests whether virtual Salter, Dega, San Diego, and Pemberton osteotomies performed on 3D MRI models can predict the hip socket shape after surgery in children and adolescents with DDH.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Istanbul University (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07581717 on ClinicalTrials.gov |
What this trial studies
Preoperative hip MRI will be used to create participant-specific 3D pelvis-acetabulum models on which standardized virtual Salter, Dega, San Diego, and Pemberton osteotomies are applied. The team will measure resulting acetabular volume, surface area, coverage distribution, and other predefined 3D morphometric parameters for each virtual technique. Early postoperative MRI (3–8 weeks after surgery) will produce the actual postoperative 3D morphology to compare with the virtual result of the osteotomy actually performed. Validation metrics will include absolute differences, bias, and Bland–Altman limits of agreement, with secondary analyses of reliability, workflow feasibility, and relationships between preoperative markers and prediction error.
Who should consider this trial
Good fit: Children and adolescents aged 2–18 years with developmental dysplasia of the hip or residual acetabular dysplasia who are scheduled for a primary Salter, Dega, San Diego, or Pemberton osteotomy and can undergo preoperative and early postoperative hip MRI.
Not a fit: Patients with hip problems from other causes (Perthes disease, slipped capital femoral epiphysis, neuromuscular disease), prior pelvic or femoral osteotomy or implants that significantly alter anatomy, or those who cannot safely have MRI are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, surgeons could use patient-specific virtual models to choose and plan the osteotomy that best restores the hip socket, improving surgical precision and likely outcomes.
How similar studies have performed: MRI-based 3D morphometric modeling has been used in hip research, but directly comparing these four pediatric osteotomies with virtual planning and validating predictions against early postoperative MRI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 2 to 18 years 2. Developmental dysplasia of the hip or residual acetabular dysplasia 3. Primary Salter, Dega, San Diego, or Pemberton acetabular osteotomy planned at Istanbul University, Istanbul Faculty of Medicine 4. Preoperative hip MRI available within 6 weeks before surgery 5. Early postoperative hip MRI available 3 to 8 weeks after surgery 6. MRI quality adequate for three-dimensional morphometric analysis 7. Unilateral or bilateral cases eligible Exclusion Criteria: 1. Hip pathology not related to developmental dysplasia of the hip, including Perthes disease, slipped capital femoral epiphysis, neuromuscular dysplasia, or infection/trauma sequelae 2. Previous surgery on the same hip that significantly alters anatomy, including prior pelvic or femoral osteotomy or open reduction, or current metal implant/fusion 3. MRI contraindication or safety issue, including MR-incompatible implant/device, severe claustrophobia, or a medical barrier to sedation/anesthesia 4. MRI not compatible with protocol or inadequate for analysis
Where this trial is running
Istanbul
- Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Yavuz Sağlam, M.D. — Istanbul University
- Study coordinator: Yavuz Sağlam, M.D.
- Email: yavuzsaglam84@istanbul.edu.tr
- Phone: +90 536 320 5005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Developmental Dysplasia of the Hip, Acetabular Dysplasia, Salter osteotomy, Dega osteotomy, San Diego osteotomy, Pemberton osteotomy, Developmental dysplasia of the hip, Acetabular dysplasia