A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 12
- 主要终点
- Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
研究概览
简要总结
This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
- •Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Patient has a Body Mass Index (BMI) >
- •Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- •Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- •Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- •Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •Patient has a failed unicondylar knee prosthesis.
- •Patient has a known sensitivity to device materials.
- •Patient is a prisoner.
研究组 & 干预措施
Triathlon TS Knee
Triathlon TS Knee System
干预措施: Triathlon TS Knee System (Device)
结局指标
主要结局
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
时间窗: pre-op, 2 years
KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).
次要结局
- Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits(pre-op, 1, 2, 5 years)
- Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative(2 year and 5 year postoperative)
- Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits(pre-op, 1, 2, 5 years)
- Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits(pre-op, 1, 2, 5 years)
- Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component(5 years)
- Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative(2 years, 5 years)
- Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative(2 year and 5 year postoperative)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits(pre-op, 1, 2, 5 years)
- Knee Society Score (KSS) Change From Pre-op to Post-op Visits(pre-op, 1,2, 5 year)
- Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative(1, 2, 5 years)