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Computer-Assisted Comparison of Hip Socket Volume and Surface Shape After Pediatric Acetabular Osteotomies

Computer-Assisted Comparative Analysis of Acetabular Volume and Surface Morphology in Pediatric Acetabular Osteotomies (Salter, Dega, San Diego, and Pemberton)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07581717
Acronym
PAVMS
Enrollment
12
Registered
2026-05-12
Start date
2026-05-10
Completion date
2026-10-15
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acetabular Dysplasia, Developmental Dysplasia of the Hip, Developmental Dysplasia of the Hip (DDH)

Keywords

Salter osteotomy, Dega osteotomy, San Diego osteotomy, Pemberton osteotomy, Developmental dysplasia of the hip, Acetabular dysplasia, Magnetic resonance imaging, Three dimensional modeling, Acetabular morphometry, Methodological validation

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURESalter 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.

PROCEDUREDega 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.

PROCEDURESan Diego osteotomy

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.

PROCEDUREPemberton osteotomy

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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Osteotomy-type differences in simulated acetabular morphometryBaseline (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).
Virtual-to-actual agreement of postoperative acetabular morphometry for the clinically performed osteotomyBaseline 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.

Secondary

MeasureTime frameDescription
Osteotomy-type differences in virtual-to-actual prediction errorBaseline and early postoperative MRI (3 to 8 weeks after surgery)Comparison of validation error among clinically performed Salter, Dega, San Diego, and Pemberton osteotomies.
Interobserver reliability of MRI-based segmentation and morphometric measurementsBaseline and early postoperative MRI (3 to 8 weeks after surgery)Interobserver agreement for segmentation and morphometric measurements, reported using intraclass correlation coefficients.
Intraobserver reliability of MRI-based segmentation and morphometric measurementsBaseline and early postoperative MRI (3 to 8 weeks after surgery)Intraobserver agreement for repeat measurements, reported using intraclass correlation coefficients.
Workflow processing timeFrom baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeksTime required for segmentation, virtual osteotomy simulation, and morphometric analysis.
Workflow completion rateFrom baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeksProportion of enrolled participants with a complete protocol-compatible analyzable dataset.

Countries

Turkey (Türkiye)

Contacts

CONTACTYavuz Sağlam, M.D.
yavuzsaglam84@istanbul.edu.tr+90 536 320 5005
CONTACTİsmail T. Atasoy, M.D.
tarik.atasoy@istanbul.edu.tr+90 534 632 0870
PRINCIPAL_INVESTIGATORYavuz Sağlam, M.D.

Istanbul University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026