Post Market Clinical Follow-Up (PMCF) Study to Evaluate the Performance and Safety of the Cemented TrendHip® Stem in a Prospective Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Aesculap AG
- 入组人数
- 119
- 试验地点
- 6
- 主要终点
- Change of functional outcome over five year follow-up period (modified Harris Hip Score)
研究概览
简要总结
This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational product (representative of usual clinical practice), at two follow-up examinations
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Inclusion: Inclusion criteria
- •Patient older than 18 years.
- •Patient who undergo / underwent a hip arthroplasty with cemented TrendHip® femoral stem according to the indications for implantation specified in the Instructions for Use.
- •Patient not opposing participation in the study.
排除标准
- •Patient with shortened life expectancy.
- •The patient is unable to commit to the planned follow-up period.
研究组 & 干预措施
TrendHip®
干预措施: Total Hip Arthroplasty (Device)
结局指标
主要结局
Change of functional outcome over five year follow-up period (modified Harris Hip Score)
时间窗: preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop)
The modified Harris Hip Score (mHHS) as patient-reported outcome measure and evaluated one-year and five-years postoperatively. The mHHS is a validated and disease-specific instrument commonly used to assess outcomes in total hip arthroplasty. The domains covered are pain, function (gait), and functional activities.
次要结局
- Patient satisfaction with surgery result(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Radiological Outcome: Migration of the stem in mm(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Pain Assessment(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Survival rate (Kaplan-Meier)(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Radiological Outcome: Heterotopic Ossification(at two examinations during Follow-Up (1 year postop, 5 years postop))