NCT02126345Unknown不适用
A Prospective, Observational, Multi-centre, Cohort Study of the MASTER SL Femoral Stem and the DELTA TT Acetabular Cup in Patients With Degenerative Disease of the Hip
Limacorporate S.p.a4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Rate of failure
研究概览
简要总结
The purpose of this study is:
- to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation;
- to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use;
- to determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female ≥18 years;
- •Radiologically confirmed diagnosis of primary osteoarthritis (OA) of the hip and suitable for primary total hip replacement;
- •Life expectancy of >10 years;
- •Voluntary written Informed Consent obtained.
排除标准
- •Prospect for recovery to independent mobility compromised by known coexistent, medical problems;
- •Requiring revision hip replacement;
- •Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
- •Previous organ transplant;
- •Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months;
- •Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points;
- •Body mass index (kg/m2) exceeds 40;
- •Active or suspected infection;
- •Known sensitivity to device materials;
- •Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.
结局指标
主要结局
Rate of failure
时间窗: 3 years
次要结局
- Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L(from baseline to all time-points)
研究者
研究点 (4)
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