Computer-Assisted Comparison of Hip Socket Volume and Surface Shape After Pediatric Acetabular Osteotomies (PAVMS)
24. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Detailní popis
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 studie
Pozorovací
Zápis (Odhadovaný)
12
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Yavuz Sağlam, M.D.
- Telefonní číslo: +90 536 320 5005
- E-mail: yavuzsaglam84@istanbul.edu.tr
Studijní záloha kontaktů
- Jméno: İsmail T. Atasoy, M.D.
- Telefonní číslo: +90 534 632 0870
- E-mail: tarik.atasoy@istanbul.edu.tr
Studijní místa
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Istanbul, Turecko (Türkiye), 34093
- Nábor
- Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
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Kontakt:
- Yavuz Sağlam, M.D.
- Telefonní číslo: +90 536 320 5005
- E-mail: yavuzsaglam84@istanbul.edu.tr
-
Kontakt:
- İsmail T. Atasoy, M.D.
- Telefonní číslo: +90 534 632 0870
- E-mail: tarik.atasoy@istanbul.edu.tr
-
Vrchní vyšetřovatel:
- Yavuz Sağlam, M.D.
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Dílčí vyšetřovatel:
- İsmail T. Atasoy, M.D.
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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
Popis
Inclusion Criteria:
- Age 2 to 18 years
- Developmental dysplasia of the hip or residual acetabular dysplasia
- Primary Salter, Dega, San Diego, or Pemberton acetabular osteotomy planned at Istanbul University, Istanbul Faculty of Medicine
- Preoperative hip MRI available within 6 weeks before surgery
- Early postoperative hip MRI available 3 to 8 weeks after surgery
- MRI quality adequate for three-dimensional morphometric analysis
- Unilateral or bilateral cases eligible
Exclusion Criteria:
- Hip pathology not related to developmental dysplasia of the hip, including Perthes disease, slipped capital femoral epiphysis, neuromuscular dysplasia, or infection/trauma sequelae
- Previous surgery on the same hip that significantly alters anatomy, including prior pelvic or femoral osteotomy or open reduction, or current metal implant/fusion
- MRI contraindication or safety issue, including MR-incompatible implant/device, severe claustrophobia, or a medical barrier to sedation/anesthesia
- MRI not compatible with protocol or inadequate for analysis
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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.
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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.
Ostatní jména:
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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.
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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.
Ostatní jména:
|
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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.
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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.
Ostatní jména:
|
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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.
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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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Osteotomy-type differences in simulated acetabular morphometry
Časové okno: Baseline (preoperative MRI-based virtual simulation, within 6 weeks before surgery)
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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).
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Baseline (preoperative MRI-based virtual simulation, within 6 weeks before surgery)
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Virtual-to-actual agreement of postoperative acetabular morphometry for the clinically performed osteotomy
Časové okno: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
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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.
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Baseline and early postoperative MRI (3 to 8 weeks after surgery)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Osteotomy-type differences in virtual-to-actual prediction error
Časové okno: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
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Comparison of validation error among clinically performed Salter, Dega, San Diego, and Pemberton osteotomies.
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Baseline and early postoperative MRI (3 to 8 weeks after surgery)
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Interobserver reliability of MRI-based segmentation and morphometric measurements
Časové okno: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
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Interobserver agreement for segmentation and morphometric measurements, reported using intraclass correlation coefficients.
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Baseline and early postoperative MRI (3 to 8 weeks after surgery)
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Intraobserver reliability of MRI-based segmentation and morphometric measurements
Časové okno: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
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Intraobserver agreement for repeat measurements, reported using intraclass correlation coefficients.
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Baseline and early postoperative MRI (3 to 8 weeks after surgery)
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Workflow processing time
Časové okno: From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
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Time required for segmentation, virtual osteotomy simulation, and morphometric analysis.
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From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
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Workflow completion rate
Časové okno: From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
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Proportion of enrolled participants with a complete protocol-compatible analyzable dataset.
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From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Yavuz Sağlam, M.D., Istanbul University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- du Cluzel de Remaurin X, Khouri N, Georges S, Gajny L, Vergari C, Badina A. Methods for three-dimensional characterization of the acetabulum prior to pelvic reorientation osteotomy: a scoping review. EFORT Open Rev. 2024 Aug 1;9(8):762-772. doi: 10.1530/EOR-22-0126.
- Badrinath R, Jeffords ME, Bomar JD, Ahmed SI, Pennock AT, Upasani VV. 3D Characterization of Acetabular Deficiency in Children with Developmental Dysplasia of the Hip. Indian J Orthop. 2021 Jul 23;55(6):1576-1582. doi: 10.1007/s43465-021-00458-7. eCollection 2020 Dec.
- van Bosse H, Wedge JH, Babyn P. How are dysplastic hips different? A three-dimensional CT study. Clin Orthop Relat Res. 2015 May;473(5):1712-23. doi: 10.1007/s11999-014-4103-y. Epub 2014 Dec 19.
- Caffrey JP, Jeffords ME, Farnsworth CL, Bomar JD, Upasani VV. Comparison of 3 Pediatric Pelvic Osteotomies for Acetabular Dysplasia Using Patient-specific 3D-printed Models. J Pediatr Orthop. 2019 Mar;39(3):e159-e164. doi: 10.1097/BPO.0000000000001271.
- Zeng G, Schmaranzer F, Degonda C, Gerber N, Gerber K, Tannast M, Burger J, Siebenrock KA, Zheng G, Lerch TD. MRI-based 3D models of the hip joint enables radiation-free computer-assisted planning of periacetabular osteotomy for treatment of hip dysplasia using deep learning for automatic segmentation. Eur J Radiol Open. 2020 Dec 18;8:100303. doi: 10.1016/j.ejro.2020.100303. eCollection 2021.
- Nakamura T, Wada A, Natori T, Kawaguchi K, Takamura K, Yanagida H, Yamaguchi T. A Novel Method for Assessing the 3-dimensional Morphology of Cartilaginous Acetabulum Via Childhood Magnetic Resonance Imaging. J Pediatr Orthop. 2023 Nov-Dec 01;43(10):640-648. doi: 10.1097/BPO.0000000000002510. Epub 2023 Sep 8.
- Bellova P, Blum S, Hartmann A, Thielemann F, Gunther KP, Goronzy J. MRI-based assessment of acetabular version and coverage after previous Pemberton osteotomy in skeletally mature patients. J Child Orthop. 2021 Jun 1;15(3):223-231. doi: 10.1302/1863-2548.15.210010.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
10. května 2026
Primární dokončení (Odhadovaný)
30. září 2026
Dokončení studie (Odhadovaný)
15. října 2026
Termíny zápisu do studia
První předloženo
28. března 2026
První předloženo, které splnilo kritéria kontroly kvality
6. května 2026
První zveřejněno (Aktuální)
12. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
26. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025/1914
Plán pro data jednotlivých účastníků (IPD)
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NEROZHODNÝ
Popis plánu 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.
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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