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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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 indica
• Процедура 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 indic
• Процедура 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

• Osteotomy-type differences in virtual-to-actual prediction error [Срок оценки: Baseline and early postoperative MRI (3 to 8 weeks after surgery)]
• Interobserver reliability of MRI-based segmentation and morphometric measurements [Срок оценки: Baseline and early postoperative MRI (3 to 8 weeks after surgery)]
• Intraobserver reliability of MRI-based segmentation and morphometric measurements [Срок оценки: Baseline and early postoperative MRI (3 to 8 weeks after surgery)]
• Workflow processing time [Срок оценки: From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks]
• Workflow completion rate [Срок оценки: From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatol — Istanbul

Публикации

• 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. PMID 39087510
• 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. PMID 34987728
• 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. PMID 25524428
• 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. PMID 30300278
• 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. PMID 33364259
• 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. PMID 37681305
• 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. PMID 34211598

Идентификаторы

NCT: NCT07581717 · 2025/1914

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗