Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma Rotating Platform (Mobile Bearing) Total Knee Systems.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To Compare Range of Motion (ROM) between subjects receiving Sigma Rotating Platform mobile bearing and Sigma fixed bearing components
研究概览
简要总结
This post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The first patient had surgery on November 8, 2001 and the final patient had surgery on July 29, 2005. There were 120 knees consented by a single site, which was the planned sample size in the study protocol, with 117 receiving one of the study devices. The study was terminated as the primary outcome was met and the investigator decided to conduct the study without sponsor support after 2009.
详细描述
Performance and safety will be assessed using the following surgeon and patient based outcome tools:
- American Knee Society Knee and Function Scores
- Knee Society Radiological Analysis
- Oxford Knee Score
- SF 12 Score
- Anterior Knee Pain Score
Specific objectives of the evaluation being to assess the following:
- Improvement in functional recovery
- Incidence of anterior knee pain
- Improvement in Quality of life
- Incidence of tibial loosening
- Incidence of excessive polyethylene wear
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Administrative - The patient or their authorised representative is able to understand the evaluation, is able to give voluntary written informed consent and will comply with the post operative follow up regime.
- •Age - There are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation.
- •Sex - Male or female (providing that they are not pregnant) may be recruited to the evaluation.
- •Diagnosis - patients that require a tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
- •Suitability - Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing tibial knee system and are suitable for patella resurfacing.
排除标准
- •Patients with rheumatoid arthritis.
- •Patients requiring revision total knee arthroplasty surgery.
- •Patients with any tibial deformity requiring tibial component augmentation.
- •Patients that in the opinion of the clinical investigators require a constrained prosthesis.
- •Patients with a known history of poor compliance to medical treatment.
- •Patients who are known drug or alcohol abusers.
- •Patients with a pathology which in the opinion of the clinical investigator will adversely affect healing.
- •Patients who are currently participating in another clinical evaluation.
- •Patients with other disorders which in the opinion of the Clinical Investigator will / could impair rehabilitation.
- •Contra-indications for use of the device, as detailed in the package insert.
结局指标
主要结局
To Compare Range of Motion (ROM) between subjects receiving Sigma Rotating Platform mobile bearing and Sigma fixed bearing components
时间窗: 1 year
Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.
次要结局
- Change in Anterior Knee Pain from Baseline to 1 and 2 years(1 and 2 years)
- Incidence of Femoral Radiolucencies at one year(6 weeks to 3 Months through 1 year)
- Change in Oxford Knee Score from Baseline to 1 and 2 years(1 and 2 years)
- Incidence of Patellar Radiolucencies at one year(6 weeks to 3 Months through 1 year)
- Change in SF-12 Physical and Mental Component Scores from Baseline to 1 and 2 years(1 and 2 years)
- Change in American Knee Society Knee and Function Scores from Baseline to 1 and 2 years(1 and 2 years)
- Incidence of Tibial Radiolucencies at one year(6 weeks to 3 Months through 1 year)