A Post-market Study Evaluating Clinical and Radiographic Early Outcomes of Hip Arthroplasty With Logica Mirror Stem.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Harris Hip Score - Functional change
研究概览
简要总结
Logica Mirror femoral stem is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect additional evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within three years after the surgery, and thus to assess the short-term performance and safety of this implant.
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 partial or total hip arthroplasty and implanted with LOGICA MIRROR femoral stem between Jan 2010 and Dec 2021 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
研究组 & 干预措施
Logica Mirror
Since the trial is not comparative, the only arm implies the use of the investigational device (Logica Mirror femoral stem)
干预措施: Hip arthroplasty with Logica Mirror femoral stem (Procedure)
结局指标
主要结局
Harris Hip Score - Functional change
时间窗: From preoperative (baseline) to 3 years after surgery
Functional change in Harris Hip Score (HHS). The maximum score of HHS is 100 points. Pain domain contributes 44 points, function 47, ROM 5 and absence of deformity 4 points. Results can be interpreted with the following: Less than 60= failed result; 60 to 69= poor result; 70 to 79= fair; 80 to 90= good; 90 to 100= excellent;
次要结局
- Oxford Hip Score - Functional change(From preoperative (baseline) to 3 years after surgery)
- VAS satisfaction(From 6 weeks to 3 years after surgery)
- Radiographic implant evaluation and stability assessment of Logica Mirror stem(From discharge to 3 years after surgery)
- Survival rate of the implant(3 years)
- Safety profile of Logica Mirror by recording adverse events (AE), serious adverse events (SAE), device deficiency (DD), adverse device effect (ADE), serious adverse device effect (SADE)(From intraoperative to 3 years after surgery)