LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline
研究概览
简要总结
To collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the LinkSymphoKnee total knee replacement system with ultra-congruent tibial bearing surface.
详细描述
The study will collect outcomes data on up to 600 patients from up to 3 sites using a legally marketed device according to its labeled intended use.
The study will collect:
- KOOS-JR
- Knee Society Score (KSS), 2011
- PROMIS Global Health
- PROMIS Physical Function
- PROMIS Pain Interference
- Surgery Satisfaction
- Forgotten Joint Score
- Radiographic findings
- Revisions.
Radiographic evaluations will be done through postoperative year 2. Other outcomes will be evaluated up to postoperative year 5.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older, and skeletally mature; and
- •Undergoing a primary TKA for one or both knees using the cemented LinkSymphoKnee knee system as part of the surgeon's standard of care.
- •Able to read and understand English (because patient-reported outcome questionnaires are not validated for all potential other languages).
排除标准
- •80 years of age or older,
- •Women who are pregnant at the time of surgery,
- •History of joint sepsis,
- •Bone defect that requires grafting,
- •Previous history of bone disease (e.g., severe osteoporosis or osteomalacia) which in the surgeon's opinion is severe enough to compromise device fixation,
- •Systemic conditions affecting bone density (e.g., inflammatory arthritis or renal disease) which in the surgeon's opinion are severe enough to compromise device fixation,
- •A poorly functioning contralateral total knee replacement or a contralateral revision regardless of function.
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline
时间窗: 1 year postoperative
Patient-reported outcome measure (PROM) that assesses knee health based on questions about pain, stiffness, function, and daily activities. Minimum score = 0. Maximum score = 100. Higher score means a better outcome.
Revision rate
时间窗: 5 years postoperative
Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.
次要结局
- Knee Society Score - change from baseline(postoperative intervals through 5 years)
- PROMIS Global Health Score - change from baseline(postoperative intervals through 5 years)
- Surgery Satisfaction Score(1 and 5 years postoperative)
- Forgotten Joint Score(postoperative intervals through 5 years)
- Knee Society Roentgenographic Evaluation and Scoring System(Through 2 years postoperative)
- PROMIS Pain Interference Score - change from baseline(postoperative intervals through 5 years)
- PROMIS Physical Function Score - change from baseline(postoperative intervals through 5 years)