An observational study in Developmental Dysplasia of the Hip (DDH), Developmental Dysplasia of the Hip and Acetabular Dysplasia, sponsored by Istanbul University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Istanbul University · Observational
The goal of this observational study is to learn how four acetabular osteotomy techniques change the shape of the hip socket in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia.
The main questions it aims to answer are:
How do virtual Salter, Dega, San Diego, and Pemberton osteotomies differ in acetabular volume and surface shape on participant-specific three-dimensional models? How closely does the virtual result of the osteotomy actually performed match the early postoperative magnetic resonance imaging (MRI)?
Participants will have a three-dimensional pelvis-acetabulum model created from preoperative MRI. Researchers will perform virtual Salter, Dega, San Diego, and Pemberton osteotomies on that model and measure the resulting acetabular morphology. The virtual result of the osteotomy actually performed will then be compared with the participant's early postoperative MRI.
This is a single-center, prospective, observational methodological validation study in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia who are undergoing Salter, Dega, San Diego, or Pemberton acetabular osteotomy.
The study has two linked analytical components. First, participant-specific three-dimensional pelvis-acetabulum models will be generated from preoperative MRI obtained within 6 weeks before surgery. Standardized virtual Salter, Dega, San Diego, and Pemberton osteotomies will then be applied on each participant's preoperative model to compare the expected effect of each technique on acetabular volume, surface area, coverage distribution, and other predefined three-dimensional morphometric parameters.
Second, early postoperative MRI obtained 3 to 8 weeks after surgery will be used to derive actual postoperative three-dimensional morphology. The virtual output corresponding to the osteotomy actually performed clinically will then be compared with the postoperative MRI-derived morphology to quantify prediction accuracy using absolute difference, bias, and Bland-Altman limits of agreement.
Additional analyses will compare validation performance by osteotomy type, assess interobserver and intraobserver reliability, measure workflow feasibility, and explore associations between preoperative morphometric markers and prediction error.
60 studies on the registry are indexed under Developmental Dysplasia of the Hip; 18 are open to participants now.
This study's planned enrollment of 12 is below the median of 72 across 21 observational studies indexed under Developmental Dysplasia of the Hip.
Browse Developmental Dysplasia of the Hip studies →Istanbul University is the lead sponsor of 511 studies on the registry; 78 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia who are scheduled for primary Salter, Dega, San Diego, or Pemberton acetabular osteotomy at Istanbul University, Istanbul Faculty of Medicine
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Participants with DDH or residual acetabular dysplasia undergoing primary Salter acetabular osteotomy as part of routine clinical care, with preoperative MRI-based 3D modeling and early postoperative MRI comparison.
Procedure: Salter osteotomy
Participants with DDH or residual acetabular dysplasia undergoing primary Dega acetabular osteotomy as part of routine clinical care, with preoperative MRI-based 3D modeling and early postoperative MRI comparison.
Procedure: Dega osteotomy
Participants with DDH or residual acetabular dysplasia undergoing primary San Diego acetabular osteotomy as part of routine clinical care, with preoperative MRI-based 3D modeling and early postoperative MRI comparison.
Procedure: San Diego osteotomy
Participants with DDH or residual acetabular dysplasia undergoing primary Pemberton acetabular osteotomy as part of routine clinical care, with preoperative MRI-based 3D modeling and early postoperative MRI comparison.
Procedure: Pemberton osteotomy
Redirectional innominate osteotomy performed to improve acetabular orientation and femoral head coverage in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia. The acetabulum is reoriented as a single fragment to increase primarily anterolateral coverage. The procedure is performed as routine clinical care, with technique selection based on the treating surgeon's indication and preoperative deformity pattern.
Also known as: Salter innominate osteotomy
Incomplete transiliac acetabuloplasty performed to reshape the acetabular roof and improve femoral head coverage in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia. The osteotomy preserves a hinge at the triradiate cartilage, allowing tailored correction of acetabular deficiency according to the morphology of the dysplastic socket. The procedure is performed as routine clinical care, with technique selection based on the treating surgeon's indication and preoperative deformity pattern.
Also known as: Dega acetabuloplasty
Incomplete transiliac acetabuloplasty performed to improve acetabular coverage in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia. The procedure preserves a triradiate cartilage hinge and allows directional correction according to the location of acetabular deficiency, including posterolateral or lateral deficiency when appropriate. The procedure is performed as routine clinical care, with technique selection based on the treating surgeon's indication and preoperative deformity pattern.
Also known as: San Diego acetabuloplasty
Pericapsular acetabuloplasty performed to reshape and redirect the acetabulum in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia. The osteotomy uses the triradiate cartilage as a hinge and increases femoral head coverage by altering acetabular shape and orientation. The procedure is performed as routine clinical care, with technique selection based on the treating surgeon's indication and preoperative deformity pattern.
Also known as: Pemberton pericapsular osteotomy
Osteotomy-type differences in simulated acetabular morphometry
Comparison across virtual Salter, Dega, San Diego, and Pemberton osteotomies of predefined morphometric outputs on participant-specific preoperative 3-dimensional models, including acetabular volume (mm3), surface area (mm2), and angular parameters such as version and inclination (degrees).
Time frame: Baseline (preoperative MRI-based virtual simulation, within 6 weeks before surgery)
Virtual-to-actual agreement of postoperative acetabular morphometry for the clinically performed osteotomy
Agreement between the matched virtual osteotomy and the actual postoperative morphology, assessed using predefined morphometric outputs including acetabular volume (mm3), surface area (mm2), and angular parameters such as version and inclination (degrees); summarized using absolute difference, bias, and Bland-Altman limits of agreement.
Time frame: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Osteotomy-type differences in virtual-to-actual prediction error
Comparison of validation error among clinically performed Salter, Dega, San Diego, and Pemberton osteotomies.
Time frame: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Interobserver reliability of MRI-based segmentation and morphometric measurements
Interobserver agreement for segmentation and morphometric measurements, reported using intraclass correlation coefficients.
Time frame: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Intraobserver reliability of MRI-based segmentation and morphometric measurements
Intraobserver agreement for repeat measurements, reported using intraclass correlation coefficients.
Time frame: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Workflow processing time
Time required for segmentation, virtual osteotomy simulation, and morphometric analysis.
Time frame: From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
Workflow completion rate
Proportion of enrolled participants with a complete protocol-compatible analyzable dataset.
Time frame: From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
Plan to share: Undecided — De-identified individual participant data are not planned to be shared with other researchers. Any future sharing would require additional review of participant confidentiality protections, institutional policy, and ethics approval. Aggregate study results may be reported in scientific publications and presentations.
Started May 2026 (actual). Primary completion is estimated for Sep 2026, 4 months after the start.
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Developmental Dysplasia of the Hip →