Multi-center, Prospective, Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 3
- 主要终点
- Knee Society Score
研究概览
简要总结
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
详细描述
The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis
- •Rheumatoid arthritis
- •Other inflammatory arthritis
- •Avascular necrosis (AVN) of bone
- •Post-Traumatic Arthritis
- •Juvenile Rheumatoid Arthritis
排除标准
- •History of recent/active joint sepsis.
- •Charcot neuropathy.
- •Psycho-social disorders that would limit rehabilitation.
- •Greater than 75 years of age at the time of surgery.
- •Prior ipsilateral knee arthroplasty.
- •Metabolic disorders of calcified tissues, such as Paget's disease.
- •Severe diabetes mellitus.
- •Joint replacement due to autoimmune disorders.
- •Skeletal immaturity
结局指标
主要结局
Knee Society Score
时间窗: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.
次要结局
- Complications(On-going to end of study)
- Medical Imaging(Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.)
- Revisions(On-going to end of study)
- SF-12 Patient Outcomes(Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.)