NL-OMON48383
Withdrawn
Not Applicable
Establish implant accuracy with X-PSI Knee System - A multi-center, prospective, non-controlled post market study - X-PSI Knee System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zimmer Biomet
- Enrollment
- 30
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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