NCT00761410终止4 期
A Prospective, Non-Comparative Multi Centre Study to Evaluate the Clinical Performance of the DePuy Press Fit Condylar (P.F.C.) Sigma Rotating Platform High Flexion Knee.
DePuy International12 个研究点 分布在 7 个国家目标入组 170 人开始时间: 2004年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 170
- 试验地点
- 12
- 主要终点
- Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater.
研究概览
简要总结
The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.
详细描述
Primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater.
The secondary endpoint is to investigate the survivorship of the P.F.C. Sigma RP-F knee at 1, 2, 3, 5, 10, 15 and 20 years
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, aged between 45 and 75 years inclusive.
- •Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- •Subjects who are able to achieve a pre-operative passive range of motion of equal to or greater than 110º.
- •Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •Subjects who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
- •Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the P.F.C.® Sigma RPF knee, according to the indications specified in the package insert leaflet.
排除标准
- •Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- •Women who are pregnant.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
- •Subjects who are currently involved in any personal injury litigation claims.
- •Subjects with a known history of poor compliance to medical treatment.
- •Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis.
- •Subjects who have morbid obesity i.e. BMI ≥40.
结局指标
主要结局
Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater.
时间窗: 1 year
Proportion of cases that have a functionally stable knee (Q10 of Oxford Knee Score is 'rarely/never' or 'sometimes, or just at first'), AND can achieve 1-year post-op passive range of motion of 125 degrees or greater.
次要结局
- SF-12 1, 2, 3, 5, 10, 15 and 20 years(1, 2, 3 and 5 years)
- Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years.(1, 2, 3 and 5 years)
- Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years(1, 2, 3 and 5 years)
- Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years(1, 2, 3 and 5 years)
- Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years(1, 2, 3 and 5 years)
- American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years(1, 2, 3 and 5 years)
研究者
研究点 (12)
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