Computer-Assisted Comparison of Hip Socket Volume and Surface Shape After Pediatric Acetabular Osteotomies (PAVMS)
2026년 6월 24일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
관찰
등록 (추정된)
12
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yavuz Sağlam, M.D.
- 전화번호: +90 536 320 5005
- 이메일: yavuzsaglam84@istanbul.edu.tr
연구 연락처 백업
- 이름: İsmail T. Atasoy, M.D.
- 전화번호: +90 534 632 0870
- 이메일: tarik.atasoy@istanbul.edu.tr
연구 장소
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Istanbul, 터키 (Türkiye), 34093
- 모병
- Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
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연락하다:
- Yavuz Sağlam, M.D.
- 전화번호: +90 536 320 5005
- 이메일: yavuzsaglam84@istanbul.edu.tr
-
연락하다:
- İsmail T. Atasoy, M.D.
- 전화번호: +90 534 632 0870
- 이메일: tarik.atasoy@istanbul.edu.tr
-
수석 연구원:
- Yavuz Sağlam, M.D.
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부수사관:
- İsmail T. Atasoy, M.D.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
다른 이름들:
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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.
다른 이름들:
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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.
다른 이름들:
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Osteotomy-type differences in simulated acetabular morphometry
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Osteotomy-type differences in virtual-to-actual prediction error
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Yavuz Sağlam, M.D., Istanbul University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 10일
기본 완료 (추정된)
2026년 9월 30일
연구 완료 (추정된)
2026년 10월 15일
연구 등록 날짜
최초 제출
2026년 3월 28일
QC 기준을 충족하는 최초 제출
2026년 5월 6일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 24일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025/1914
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .