An Observational Study of Calibrated CT Scans to Evaluate Shoulder Geometry and Bone Density for Finite Element Analysis (FEA) on a Simulated Surgical Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Primary Endpoint: Collection of calibrated CT scans to obtain human imaging data to perform a Finite Element Analysis (FEA) on a simulated surgery using a specific implant, as per clinical practice.
研究概览
简要总结
The data of calibrated CT-scans will be used for the Finite Element Analysis (FEA) analysis for SMR Short Stem in identified hospitals in EU and US as developers of the project and for further research, upon subject acceptance.
In particular, the Quantitative Computer Tomography (QTC)/Finite Element Analysis (FEA) model of the assembly consisting of the shoulder and the orthopaedic implant allows detailed analyses including:
- assessment of micromotion at the bone-implant interface, to predict osseointegration;
- comparison of strains/stresses between the intact bone tissue and the bone with the implant in order to predict the stress shielding phenomenon.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects (males and/or females) must be ≥ 18 years of age
- •Subjects are willing and able to provide written informed consent for collection of the data; if a patient has already completed and performed the calibrated CT-scans as per standard clinical practice, the subject may be contacted to offer participation in the study.
- •Adult patients who will undergo noncontrast CT scanning of the shoulder as part of routine preoperative planning for shoulder arthroplasty will be eligible to participate in the study and receive a calibrated CT scan of the shoulder. The decision to undergo CT scan will be made independently of study participation; only patients who require a CT scan of the shoulder for clinically necessary reasons are eligible to participate.
排除标准
- •Pregnancy or lactation;
- •Subjects who have fracture of the affected shoulder;
- •Subjects who have had prior surgery on the affected shoulder that resulted in metal implants, including but not limited to:
- •Partial or total shoulder joint replacement;
- •Open reduction internal fixation of fracture;
- •Prior rotator cuff repair with metal implants;
- •Local or systemic infection;
- •Persistent acute or chronic osteomyelitis;
- •Focal vascular or neurologic diseases affecting the concerned limb;
- •Metabolic disorders or systemic diseases that substantially affect bone quality, including the following:
- •Renal osteodystrophy
- •Osteoporosis
- •Osteomalacia
- •Osteopetrosis
- •Bone tumors involving the shoulder girdle;
- •Local or disseminated neoplastic diseases;
- •Severe deformity including malunion, nonunion, excessive bone loss that would result in improper virtual implant positioning;
结局指标
主要结局
Primary Endpoint: Collection of calibrated CT scans to obtain human imaging data to perform a Finite Element Analysis (FEA) on a simulated surgery using a specific implant, as per clinical practice.
时间窗: <24 hours
To perform the Finite Element Analysis (FEA), the following data will be requested: * Shoulder calibrated CT-scan * Date of calibrated CT-scan execution * Subject's year of birth * Subject's sex * Subject's weight * Subject's height * Subject's ethnicity
次要结局
未报告次要终点