Computer-Assisted Comparative Analysis of Acetabular Volume and Surface Morphology in Pediatric Acetabular Osteotomies (Salter, Dega, San Diego, and Pemberton)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: San Diego osteotomy (Procedure)
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.
干预措施: Pemberton osteotomy (Procedure)
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.
干预措施: Salter osteotomy (Procedure)
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.
干预措施: Dega osteotomy (Procedure)
研究者
Yavuz Saglam
Associate Professor of Orthopedics and Traumatology
Istanbul University