Establish Implant Accuracy With X-PSI Knee System - A Multi-center, Prospective, Non-controlled Post Market Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Zimmer, GmbH
- 入组人数
- 8
- 试验地点
- 8
- 主要终点
- Mechanical Leg Alignment
研究概览
简要总结
The goal of this study is to establish the accuracy of the new X-PSI Knee System guides by analyzing early postoperative (4-6 weeks) imaging data with regards to the mechanical alignment and compare them with preoperative planning imaging data. Mechanical alignment in the hip-knee-ankle (HKA) frontal plane with X-PSI Knee System will be measured and compared with results reported in the literature using a conventional (non-guided) approach.
Hypothesis: The use of the new X-PSI Knee System achieves the same accuracy with respect to mechanical alignment as with conventional instrumentation.
详细描述
Patient-specific instruments (PSI) provide surgeons with an anatomically personalized surgery tool. The newly developed and CE-marked X-PSI Knee System is based on long leg x-rays that are used to generate a pre-operative 3D model of the knee. The total knee replacement surgery will be planned according to this 3D model.
The aim of this multi-center, prospective, non-controlled post-market study is to scientifically document the accuracy, cost-effectiveness and subsequent clinical performance of the X-PSI Knee System. The X-PSI pin guides are designed to facilitate a more simplified, efficient and customized TKA procedure compared to conventional, non-guided instrumentation.
To evaluate the accuracy of the X-PSI Knee System, early postoperative (4-6 weeks) imaging data will be analysed with regards to the mechanical alignment (hip-knee-ankle angle) of the leg and matched to preoperative planning imaging data. The X-PSI Knee System cohort will then be compared with current literature (70% of cases within ±3 degrees) where patients were conventionally operated with non-guided surgery. No control group will be studied.
The cost-effectiveness of the X-PSI Knee System will be evaluated with an efficiency matrix to record OR set-up time, surgery time and post-processing time.
Clinical outcome data of the patients will be evaluated 4-6 weeks and 1 year post-surgery with the help of patient questionnaires (VAS pain scale, EQ-5D and Oxford Knee Score), a physical exam and the assessment of radiographs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient is 18 years of age or older.
- •Patient can follow the X-PSI Knee System imaging protocol as part of standard of care procedures.
- •Patient gets TKA treatment which follows the criteria of the appropriate Instruction for Use.
- •Patient is willing and able to cooperate in the required postoperative standard of care.
- •Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- •Patient has participated in the study-related Informed Consent process and has signed the Ethics Committee approved Informed Consent
排除标准
- •Patient is unwilling or unable to give consent or to comply with the follow-up program.
- •Patient meets exclusion criteria of the appropriate Instruction for Use
- •Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required from them
- •Patient is known to be pregnant
结局指标
主要结局
Mechanical Leg Alignment
时间窗: 4-6 weeks post-surgery
Achievement of mechanical leg alignment in HKA frontal plane (± 3 degrees) with X-PSI Knee System is as accurate as with standard instrumentation at 4-6 weeks post operation. The X-PSI Knee System cohort will be compared with current literature (70% of cases within ± 3 degrees). No control group will be studied.
次要结局
- Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix(During surgery, immediate pre- and post-surgery processing time)