Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 6
- 主要终点
- Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain
研究概览
简要总结
The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.
详细描述
Objective： To compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.
Endpoint： Primary： The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.
Secondary：Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Persona TKA with iASSIST Knee system (Investigational group) or Persona TKA with conventional instrumentation (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using blocked randomization procedure. The PI or his/her team does not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a patient must meet all of the following criteria.
- •Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)
- •Male or female
- •At least 20 years of age
- •Patients willing to return for follow-up evaluations.
- •Study Specific Requirements for Principal Investigator/Site
- •Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee with Persona and Persona conventional instrument system before any study specific activities.
- •Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.
排除标准
- •Absolute contraindications include:
- •Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)
- •Too severe OA deformation (FTA: > 190 degrees/< 175 degrees)
- •Active infection (or within 6 weeks after infection)
- •Osteomyelitis
- •Any type of implant is inserted in the affected side of lower extremity
- •Hip and/or foot disease on the affected side
- •Additional contraindications include:
- •Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- •Diagnosed osteoporosis or osteomalacia
- •Metabolic disorders which may impair bone formation
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy or neuromuscular disease.
结局指标
主要结局
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain
时间窗: Postoperative 6 months
Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain
时间窗: Postoperative 6 months
Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain
时间窗: Postoperative 6 months
Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain
时间窗: Postoperative 6 months
Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.
次要结局
- Number of Instrument Trays Used(Intraoperative)
- KSS-function Score at 6 Month Postoperatively(6 month postoperative)
- EQ-5D-3L at 6 Month Postoperatively(6 month postoperative)
- KSS - Objective Score at 6 Month Postoperatively(6 month postoperative)
- KSS-Patient Satisfaction at 6 Month Postoperatively(6 month postoperative)
- Surgery Time(Intraoperative, an average of 2 hours)
- KSS-Patient Expectations at 6 Month Postoperatively(6 month postoperative)
- Oxford Knee Score at 6 Month Postoperatively(6 month postoperative)