Randomised Prospective Comparison of P.F.C All-polyethylene Versus Metal-backed Tibial Component. A Clinical, Radiological and Roentgen Stereophotogrammetric Analysis (RSA) Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Using RSA it is possible to evaluate the performance of both the all-polyethylene and metal-backed tibia components to determine whether there are differences in migration between the two components
研究概览
简要总结
The primary objective of this investigation was to evaluate & compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA.
The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components.
详细描述
Using RSA, is it possible to evaluate the performance of both the all polyethylene and metal backed tibia components to determine whether there are differences in migration, if present, across the tibial components.
The original protocol intended to perform clinical assessment using the Nottingham Knee Score and the Knee Society Clinical rating system pre-and post-operatively, at six months, 1 year, and annually thereafter. Per Protocol Amendment 01 (effective June 18, 1999) clinical data would also be collected via the SF-12 questionnaire. Radiological evaluation would also use the Knee Society scoring system at the same time points. However, data collected included only the SF-12 and Oxford Knee Scores, comparing change from baseline at 6, 12, and 24 months after surgery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects requiring a primary knee replacement.
- •Subjects aged 65 years or more.
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •Subjects with a primary diagnosis of osteoarthritis or rheumatoid arthritis.
排除标准
- •Subjects who have had a previous surgery of the operative knee except menisectomy and arthroscopy.
- •Subjects who have had a renal transplant.
- •Subjects with a metabolic bone disorder.
- •Subjects who, in the opinion of the Clinical Investigator, have an existing condition, e.g. Paget's disease etc. that would compromise their participation and follow-up in this clinical investigation.
- •Subjects whose contralateral knee is already included in this study.
- •Subjects who have a history of active joint sepsis.
- •Subjects who have a recent history of high dose systemic corticosteroids.
- •Subjects with psycho-social disorders or physical disabilities that would limit rehabilitation.
- •Subjects requiring a bone graft.
研究组 & 干预措施
1 - All Polyethylene Tibia
Total knee replacement with an all polyethylene tibial tray
干预措施: PFC Sigma knee with all-poly tibial component (Device)
2 - Poly & Metal Tibia
Total knee replacement with a metal-backed tibial component
干预措施: PFC Sigma knee with metal backed tibia (Device)
结局指标
主要结局
Using RSA it is possible to evaluate the performance of both the all-polyethylene and metal-backed tibia components to determine whether there are differences in migration between the two components
时间窗: 2 years
次要结局
- Comparative evaluation of any post-operative variation between subjects receiving all-polyethylene and metal-backed tibia components in change from baseline at each post operative time points in terms of SF 12 and OKS(6 months, 1 year and 2 years)