Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
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.
Prospective multicenter follow-up study which examines the short- to long-term post-market
 clinical data on the safety and performance of the balanSys UNI fix knee prosthesis.

 In total at least 100 participants in 3 clinics are included in this multicenter study.

 The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery.

 The following parameters will be collected during the regular clinical and radiological
 follow-up: Knee Society Score, Knee and Osteoarthritis Outcome Score (KOOS), radiographic
 evaluation and detection of adverse events.
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