A Prospective (Non)-Randomized Controlled Multicenter Clinical Study Of the Genesis ii Total Knee System in Minimally Invasive Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 试验地点
- 2
- 主要终点
- Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements
研究概览
简要总结
Overall study design:
A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system. The study will collect efficacy, safety and socio-economical data over 2 years. An additional 5 years follow-up interval is optional. The objectives (short-term follow-up) of the study are to:
- Assess whether the improvement in Pain and Range of motion per Knee Society scoring system and VAS score.
- Assess whether there are any differences between the surgical techniques as regards complication rate.
- Assess whether the hospital stay and the rehabilitation time (Straight leg raise, Active/passive ROM) of the patients differs between the two techniques.
- Assess the x-ray mechanical alignment between the two techniques.
Attempts will be made to assess whether the collected peri-operative data (including incision length, blood loss, wound appearance, hospital readmissions and operative time) differs between the two surgical techniques.
The primary objectives (mid-term follow-up) of the study are to:
- Improvement in Pain and Function per Knee Society Scoring system
- Number and Extent of Radiographic Lucencies >2mm
- Revision and knee-related adverse events
- Improvement in Quality-of-life via the VAS score
5 investigational sites will participate and enroll a total of approximately 250 patients over a 12 months period. Thus, each site will enroll 50 patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •require primary uni- or bilateral total knee arthroplasty; available for 2 year follow up; provide informed consent; is in stable health for cardio-pulmonary conditions.
排除标准
- •inefficient femoral or tibial bone stock; BMI >35; fixed flexion deformity >15 degrees; knee flexion of <90 degrees; varus/valgus deformity >20 degrees; active local infection; conditions that would compromise the 2 years follow up.
结局指标
主要结局
Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements
时间窗: 1 year
次要结局
- Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term(2 years)