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

24 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

12

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Turcja (Türkiye)
      • Istanbul, Turcja (Türkiye), 34093
        • Rekrutacyjny
        • Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Yavuz Sağlam, M.D.
        • Pod-śledczy:
          • İsmail T. Atasoy, M.D.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Procedura: 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.
Inne nazwy:
  • 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.
Procedura: 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.
Inne nazwy:
  • 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.
Procedura: 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.
Inne nazwy:
  • 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.
Procedura: 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.
Inne nazwy:
  • Pemberton pericapsular osteotomy

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Osteotomy-type differences in simulated acetabular morphometry
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Osteotomy-type differences in virtual-to-actual prediction error
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Istanbul University

Śledczy

  • Główny śledczy: Yavuz Sağlam, M.D., Istanbul University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 maja 2026

Zakończenie podstawowe (Szacowany)

30 września 2026

Ukończenie studiów (Szacowany)

15 października 2026

Daty rejestracji na studia

Pierwszy przesłany

28 marca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 maja 2026

Pierwszy wysłany (Rzeczywisty)

12 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025/1914

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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