Patient-specific Instruments as a Standard Procedure in Total Knee Arthroplasty: Logistics, Learning Curve, and Postoperative Radiological Results in 70 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Alignment
研究概览
简要总结
Description of logistics, learning curve and radiological results in 70 patients treated with patient specific instrumentation in total knee arthroplasty as a standard procedure
详细描述
The Orthopaedic Clinic Gersthof is a teaching hospital, where the entire spectrum of joint replacements with emphasis on hips and knees is performed. Twenty surgeons perform TKAs at our institution, with approximately 400 TKAs implanted per year.
The PSI system of Smith &Nephew® (Patient-Matched Cutting Blocks [PMCB]; the VISIONAIRE® technology) is applied. The preoperative image modality is based on a long leg standing X-ray as well as an MRI of the knee. The Genesis II® Endoprosthesis (Smith & Nephew®) is used as the TKA implant.
This study is a observational monocentric prospective study.
Estimated enrollment: 70 Enrollment time: September 2011-October 2012 Primary outcome: Alignment
The postoperative X-rays (AP, lateral view, and long leg standing), taken 7-to-10 days after surgery are evaluated in terms of component position and restoration of the mechanical alignment. X-rays are routinely monitor-guided but not calibrated at our institution.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Indication for TKA
- •Genesis II endoprosthesis
- •Operated using patient specific instruments (VISIONAIRE)
排除标准
- •contraindication for MRI
- •varus/ valgus deformity >15 degrees
结局指标
主要结局
Alignment
时间窗: Postoperative x-ray (7-10 days after surgery)
Alignment measured on monitor-guided x-rays: Mechanical Alignment: Hip-Knee-Ankle angle in degrees \[°\] Alignment of the tibial and femoral component in the sagittal and coronal plane \[°\]
次要结局
- Learning curve(Intraoperative and early postoperative period (up to 14 days after surgery))
研究者
Dominik Drnek
Dr. med. univ.
Orthopedic Clinic Gersthof