DEXA Bone Density Analysis to Analyze the Loading Concept of the CoreHip® Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Aesculap AG
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)
研究概览
简要总结
The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary cementless stem. The DEXA bone density analysis is used.
详细描述
Additional diagnostic examination: DEXA-Analysis. A DEXA scan is an imaging test that measures bone density (strength). The results can provide helpful details about risk for osteoporosis (bone loss) and fractures. Furthermore we would like to find out more about stress shielding processes around our prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral hip osteoarthritis
- •Indication for CoreHip Standard hip stem according to preoperative planning
- •Written Informed Consent
- •Age 35-85 years
- •According to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits
排除标准
- •Femoral neck fractures
- •Pregnancy
- •BMI > 35
- •History of femoral fracture or previous surgery on the same hip
- •Metabolic bone disease, use of steroids or other drugs affecting bone metabolism
- •Intraoperative bone cracks
- •Severe osteoarthritis of the contralateral hip
- •THA of the contralateral side or other event leading to restricted weight bearing during the study period
研究组 & 干预措施
DEXA
DEXA bone density analysis to analyze the loading concept of the CoreHip® Prosthesis System
干预措施: Primary hip replacement with cementless stem (Device)
结局指标
主要结局
Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)
时间窗: within 24 months postoperative
Changes in bone mineral density (BMD) according to Gruen.
次要结局
- Development of Forgotten Joint Score(preoperative, at discharge (1 week postop) and 12 months postoperative)
- Clinical Results: Joint Function (Harris Hip Score)(preoperative, at discharge (1 week postop) and 12 months postoperative)
- Development of Quality of Life (EQ-5D-5L)(preoperative, at discharge (1 week postop) and 12 months postoperative)
- Development of Pain(preoperative, at discharge (1 week postop) and 12 months postoperative)