NL-OMON48383撤回不适用
Establish implant accuracy with X-PSI Knee System - A multi-center, prospective, non-controlled post market study - X-PSI Knee System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
研究者
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