NCT03885531已完成不适用
Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 586
- 试验地点
- 6
- 主要终点
- Number of adverse events reported per ISO 14155 guidelines
研究概览
简要总结
The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an approved indication;
- •The TKA occurred at least 12 weeks prior to enrollment
排除标准
- 未提供
结局指标
主要结局
Number of adverse events reported per ISO 14155 guidelines
时间窗: 7 years
次要结局
- Length of hospital stay for primary (index) surgery(7 years)
- Number and type of outpatient visits(7 years)
- Number of days before return to work(7 years)
- Number of rehabilitation sessions(7 years)
- Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery(7 years)
- Duration of rehabilitation sessions in weeks(7 years)
- Number of re-operations(7 years)
- Quality of Life as measured by EQ-5D-3L score(7 years)
- Patient Pain Level as measured by Knee Society Score (KSS)(7 years)
- Number of technical difficulties encountered with the device(7 years)
- Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery(upon occurence through 7 years of study duration)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective StudyTotal Knee ArthroplastyNCT03292003Smith & Nephew, Inc.1,694
已完成
不适用
Safety and Performance of Journey II XR Total Knee SystemJourney II XR Total Knee SystemNCT03798847Smith & Nephew, Inc.683
进行中（未招募）
不适用
JOURNEY™ II CR Total Knee SystemOsteoarthritis, KneeNCT02440672Smith & Nephew, Inc.170
已完成
不适用
Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome MeasuresJourney II BCS Total Knee SystemNCT03903731Smith & Nephew, Inc.600
进行中（未招募）
不适用
JOURNEY II XR Safety and Effectiveness PMCFRheumatoid Vasculitis With Rheumatoid Arthritis of KneeUnilateral Post-Traumatic Osteoarthritis of KneeDegenerative Arthritis Peripheral JointKnee OsteoarthritisFailed OsteotomiesFailed Unicompartmental ReplacementNCT03136887Smith & Nephew, Inc.176