Status:
TERMINATED
Establish Implant Accuracy With X-PSI Knee System
Lead Sponsor:
Zimmer, GmbH
Conditions:
Knee Osteoarthritis
Post-traumatic Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 gen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03275246
Start Date
October 5 2018
End Date
November 17 2020
Last Update
October 6 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
HELIOS Kliniken Mittelweser GmbH
Nienburg, Germany, 31582
2
Knie Praxis Prof. Dr. Tibesku
Straubing, Germany, 94315
3
Zuyderland Medical Park
Sittard, Netherlands, 6162
4
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW