NCT04833634已完成不适用
Retrospective Follow-Up of the Prevision® Hip Stem in a Consecutive Case Series
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Hip stem survival measured by Kaplan-Meier
研究概览
简要总结
The main objective of this study is to represent the treatment reality at the study site and to draw conclusions from cases of failure or suboptimal outcome. Potential risk factors for revision surgery, suboptimal outcome or radiologic sign of loosening, bone non-union or stem subsidence will be evaluated. Next to the functional outcome, stem subsidence will be used as an important indicator for a stable fixation of the revision stem.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 implanted with a Prevision® hip stem at the study site between 2014 and 2019
- •Written informed patient consent
排除标准
- •Patients < 18 years at surgery
结局指标
主要结局
Hip stem survival measured by Kaplan-Meier
时间窗: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
The primary endpoint of the study is hip stem survival, which is a common indicator for implant performance, which can also be used for comparison with implant registry data.
次要结局
- Functional Outcome: Oxford Hip Score(One scheduled Follow-Up visit per patient, 2-7 years after initial implantation)
- Patient satisfaction with their endoprosthetic revision treatment(One scheduled Follow-Up visit per patient, 2-7 years after initial implantation)
- Radiological evaluation (standard x-rays): radiographic loosening(One scheduled Follow-Up visit per patient, 2-7 years after initial implantation)
- Leg length difference(One scheduled Follow-Up visit per patient, 2-7 years after initial implantation)
- Descriptive Analysis of (Serious) adverse events(One scheduled Follow-Up visit per patient, 2-7 years after initial implantation)
- Radiological evaluation (standard x-rays): stem subsidence(One scheduled Follow-Up visit per patient, 2-7 years after initial implantation)
- Radiological evaluation (standard x-rays): Bone healing(One scheduled Follow-Up visit per patient, 2-7 years after initial implantation)
- Radiological evaluation (standard x-rays): osseointegration(One scheduled Follow-Up visit per patient, 2-7 years after initial implantation)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant VariantsRevision Total Hip ArthroplastyPeriprosthetic Fracture of HipNCT06626490Aesculap AG120
招募中
不适用
Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral AllograftsOsteochondral DefectNCT04236492Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau40
招募中
不适用
Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.Hip SurgeryNCT05966220FH ORTHO800
已完成
不适用
Encore Revelation Hip StemOsteoarthritis, HipArthroplasty ComplicationsNCT01514318Encore Medical, L.P.8
Unknown
不适用
The Effects of Dapagliflozin in Normal Clinical Practice in T2DType 2 DiabetesNCT05418946University of Milan1,400