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

24. juni 2026 opdateret af: Yavuz Saglam, Istanbul University

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

12

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye), 34093
        • Rekruttering
        • Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Yavuz Sağlam, M.D.
        • Underforsker:
          • İsmail T. Atasoy, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Salter Osteotomy Cohort
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
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.
Andre navne:
  • Salter innominate osteotomy
Dega Osteotomy Cohort
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
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.
Andre navne:
  • Dega acetabuloplasty
San Diego Osteotomy Cohort
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
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.
Andre navne:
  • San Diego acetabuloplasty
Pemberton Osteotomy Cohort
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
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.
Andre navne:
  • Pemberton pericapsular osteotomy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Osteotomy-type differences in simulated acetabular morphometry
Tidsramme: 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).
Baseline (preoperative MRI-based virtual simulation, within 6 weeks before surgery)
Virtual-to-actual agreement of postoperative acetabular morphometry for the clinically performed osteotomy
Tidsramme: 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.
Baseline and early postoperative MRI (3 to 8 weeks after surgery)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Osteotomy-type differences in virtual-to-actual prediction error
Tidsramme: 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.
Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Interobserver reliability of MRI-based segmentation and morphometric measurements
Tidsramme: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Interobserver agreement for segmentation and morphometric measurements, reported using intraclass correlation coefficients.
Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Intraobserver reliability of MRI-based segmentation and morphometric measurements
Tidsramme: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Intraobserver agreement for repeat measurements, reported using intraclass correlation coefficients.
Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Workflow processing time
Tidsramme: 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.
From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
Workflow completion rate
Tidsramme: 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.
From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University

Efterforskere

  • Ledende efterforsker: Yavuz Sağlam, M.D., Istanbul University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. maj 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

15. oktober 2026

Datoer for studieregistrering

Først indsendt

28. marts 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025/1914

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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