NCT06699134招募中不适用
Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Radiographic evaluation
研究概览
简要总结
The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement.
The assessments will include:
- Radiological analysis performed at different time points according to the standard of care of the hospital
- Implant survivorship and safety based on removal of a study device
- Patient reported outcome measures (PROMs)
Primary endpoint:
Assessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).
Secondary endpoints:
- Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
- Evaluation of PROMs
- Obtain information regarding the cementing technique and handling of the cement, if available
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
- •Subject qualified for cemented TKA or THA with a Zimmer Biomet implant
- •Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray & Scores completion)
- •Subject > 18 years old
排除标准
- •Muscle wasting
- •Neuromuscular compromise in the affected limb
- •Known hypersensitivity to any of the cement constituents
- •Subjects with severe renal failure
- •Bilateral interventions
- •Subject is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, known alcohol or drug abuser, anticipated to be non-compliant)
结局指标
主要结局
Radiographic evaluation
时间窗: From enrollment to the 5 year post-op follow up.
Detection of radiolucent lines around the implant components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).
次要结局
- Survivorship(From enrollment to the 5 year post-op follow up.)
- Patient reported outcome measures (PROM)(From enrollment to the 5 year post-op follow up.)
- Cement Information(From enrollment to the 5 year post-op follow up.)
研究者
研究点 (1)
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