Establish implant accuracy with X-PSI Knee System - A multi-center, prospective, non-controlled post market study

Withdrawn

Conditions: Knee cartilage wear/ patient specific instrumentation
10023213
10005944

Registration Number: NL-OMON48383

Lead Sponsor: Zimmer Biomet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

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
has signed the Ethics Committee approved Informed Consent

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Achievement of mechanical leg alignment in Hip-Knee-Ankle (HKA) frontal plane<br /><br>(± 3 degrees) with X-PSI Knee System is as accurate as with standard<br /><br>(non-guided) instrumentation at 4-6 weeks post operation. The X-PSI Knee System<br /><br>cohort will be compared with current literature (70% of cases within ± 3<br /><br>degrees). No control group will be studied.</p><br>

Secondary Outcome Measures