Prospective, Randomized, Single-blind, Multinational, Long-term Study for the Evaluation of the Clinical Outcome, Oxidation Profile and Wear Analysis of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
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
- 605
- 试验地点
- 8
- 主要终点
- Clinical Outcome measured with the KSS [performance]
研究概览
简要总结
Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for a total knee replacement with a mobile-bearing UC or PS inlay
- •Written informed consent for participating at the clinical study
- •Willingness and mental ability to participate at the long-term follow-up examinations
排除标准
- •Patient age < 18 and > 80 years
- •Pregnancy
- •High risk patients (ASA class >3)
结局指标
主要结局
Clinical Outcome measured with the KSS [performance]
时间窗: 10 years postoperatively
The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA. It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.
次要结局
- Progress of Clinical Outcome [Oxford Score] compared to baseline(Preoperatively, 3 months, 12 months, 3 years, 5 years, 7 years, 10 years)
- Survival rate(until the last follow-up at 10 years postoperatively)
- Quality of Life [EQ-5D-5L](Preoperatively, 3 months, 12 months, 5 years, 10 years)
- Comparison of Radiographic evaluation over time(baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years)
- Comparison of Radiographic alignment over time(baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years)
- Oxidation profile and wear analysis of available retrievals(During the course of the study up to 10 years postoperatively)
- Further analysis of patients having a revision of the primary implant(During the course of the study up to 10 years postoperatively)
- (Serious) Adverse Events(During the course of the study up to 10 years postoperatively)