NCT00289081终止不适用
Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 399
- 试验地点
- 5
- 主要终点
- Knee Society scores
研究概览
简要总结
The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
详细描述
The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.
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
- 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
- •Avascular necrosis (AVN) of bone
- •Other inflammatory arthritis
- •Post-traumatic arthritis
- •Juvenile rheumatoid arthritis
排除标准
- •Prior ipsilateral TKA
- •Metabolic disorders
- •Joint replacement due to autoimmune disorders
- •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
- •Severe diabetes mellitus
- •Skeletal immaturity
结局指标
主要结局
Knee Society scores
时间窗: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
次要结局
- Revisions(On-going to end of study)
- Complications(On-going to end of study)
- Medical imaging(Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.)
- SF-12 patient outcomes(Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.)
研究者
研究点 (5)
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