NCT Number: NCT07581717
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.
Interested in participating?
Request Info2 year–18 year
All sexes
Observational
Istanbul, 34093, Turkey (Türkiye)
Location status: Recruiting
Yavuz Sağlam, M.D.
CONTACT
Yavuz Sağlam, M.D.
PRINCIPAL_INVESTIGATOR
İsmail T. Atasoy, M.D.
CONTACT
İsmail T. Atasoy, M.D.
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: 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.
Other names: 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.
Other names: Pemberton pericapsular osteotomy
Time frame: Baseline (preoperative MRI-based virtual simulation, within 6 weeks before surgery)
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 and early postoperative MRI (3 to 8 weeks after surgery)
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)
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 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 agreement for repeat measurements, reported using intraclass correlation coefficients.
Time frame: From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
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
Proportion of enrolled participants with a complete protocol-compatible analyzable dataset.
Contact information is provided by the study sponsor or research team.
Yavuz Sağlam, M.D.
CONTACT
İsmail T. Atasoy, M.D.
CONTACT
Istanbul University
Other
Computer-Assisted Comparative Analysis of Acetabular Volume and Surface Morphology in Pediatric Acetabular Osteotomies (Salter, Dega, San Diego, and Pemberton)
Acronym: PAVMS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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