Stryker NTX Registry Scorpio NRG Triathlon Total Knee, Triathlon PKR With X3 Insert International Multicentre Outcomes Register
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 237
- 试验地点
- 6
- 主要终点
- Survivorship of the Device
研究概览
简要总结
Provide outcomes information with regard to surgical and implant performance and patient clinical outcomes of the patients who are eligible for either a Total Knee Arthroplasty (TKA) replacement surgery or Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA)
详细描述
The objective of this registry is to provide outcomes information with regard to surgical and implant performance and patient clinical outcomes of the patients who are eligible for a either a Total Knee Arthroplasty (TKA) replacement surgery involving the Scorpio NRG or Triathlon Total Knee System or Triathlon PKR Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA), all of which with X3 inlay. The register will follow the standard clinical procedures used by the institutions for patient selection for knee arthroplasty surgery, patient surgery and patient follow-up. Therefore there will be, with regard to this register, no additional assessment, examination, procedure or follow-up visits compared to those usually performed in the institution (routine standard normal procedures).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring primary TKA, suitable for the use of the Scorpio NRG with X3 insert or Triathlon Total Knee System with X3 insert, or, patients requiring partial knee resurfacing (unicompartmental knee) suitable for the use of the Triathlon PKR (Partial Knee Resurfacing) System with X3 insert
- •Patients who understand the conditions of the outcomes registry and are willing and able to comply with the standard post-operative evaluations and the prescribed rehabilitation.
- •Patients who signed the Informed Consent Form (approved by Ethics Committee if required) prior to surgery.
排除标准
- 未提供
研究组 & 干预措施
Triathlon Partial Knee Resurfacing
Patients eligible for Triathlon PKR System with X3 insert
干预措施: Partial Knee Resurfacing (Procedure)
Scorpio NRG Total Knee System
Patients eligible for Scorpio NRG Total Knee System with X3 insert
干预措施: Scorpio NRG Total Knee System with X3 insert (Device)
Scorpio NRG Total Knee System
Patients eligible for Scorpio NRG Total Knee System with X3 insert
干预措施: Total Knee Replacement (Procedure)
Triathlon Total Knee System
Patients eligible for Triathlon Total Knee System with X3 insert
干预措施: Triathlon Total Knee System with X3 insert (Device)
Triathlon Total Knee System
Patients eligible for Triathlon Total Knee System with X3 insert
干预措施: Total Knee Replacement (Procedure)
Triathlon Partial Knee Resurfacing
Patients eligible for Triathlon PKR System with X3 insert
干预措施: Triathlon PKR System with X3 insert (Device)
结局指标
主要结局
Survivorship of the Device
时间窗: Preoperative to 1 year, 1 year, 3 years, and 5 years. Survivorship is unavailable at 10 years due to study termination.
Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).
次要结局
- Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)(Pre-operative, 1, 3, and 5 years. The KSS for 7 and 10 year timepoints are unavailable due to study termination.)
- Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.(Pre-operative, 1, 3, and 5 years. The KOOS for 7 and 10 year timepoints are unavailable due to study termination.)
- Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.(Pre-operative, 1, 3, and 5 years. The EQ-5D for 7 and 10 year timepoints is unavailable due to study termination.)