Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block … (NCT04598568) | Clinical Trial Compass
CompletedNot Applicable
Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
116 participantsStarted 2012-05-15
Plain-language summary
The purpose of the study is the evaluation of the clinical and radiological long-term performance of the balanSys UNI fix in a multicenter routine clinical setting.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed consent form (signed by participant and investigator)
* Primary implantation
* Age at inclusion: Between 18 and 90 years old
* Willing to participate in the follow-up
Exclusion Criteria:
* Missing Informed consent form
* Known or suspected non-compliance (e.g. drug or alcohol abuse)
* Enrollment of the investigator, his/her family, employees and other dependent persons
* Patient younger than 18 years old
* Revision surgery
* Does have a known allergy to metal in medical devices
* Suffers from ACL rupture
* Pregnancy or in the breast feeding period