NCT04979104已完成不适用
A Post-market Study Evaluating Clinical and Radiographic Early Outcomes Pf Hip Arthroplasty with SL Cementless Stem.
Limacorporate S.p.a1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Implant radiographic stability
研究概览
简要总结
The study aims to evaluate the clinical, radiographical and patient-reported outcomes measurements up 3 years FU and to assess the survivorship of SL Cementless Stem after partial or total hip arthroplasty.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •All patients that underwent to partial or total hip arthroplasty and implanted with SL cementless stem between Jan 2010 and Jan 2020 at Nemocnice Kyjov Hospital (CZ) in accordance with the indication for use of the product and site standard of practice.
- •Additional Inclusion criteria:
- •Availability of patients' immediate post-operative radiograph (baseline) and of a number of follow-up x-rays that the Principal Investigator deems sufficient for an effective radiographic implant evaluation and stability assessment;
- •Patient is willing and able to complete additional follow-up evaluations if needed after signing ICF.
排除标准
- •Age < 18 years;
- •Female patients who are pregnant, nursing, or planning a pregnancy
结局指标
主要结局
Implant radiographic stability
时间窗: 3 years FU
Radiographic implant evaluation and stability assessment of the SL Cementless Stem on collected radiographs as per clinical practice during hospitalization and routine visits.
次要结局
- Implant safety profile(6 weeks, 3 months, 1 year, 3 years after surgery)
- Clinical outcomes(6 weeks, 3 months, 1 year, 3 years after surgery)
研究者
研究点 (1)
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