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.
Study Type
OBSERVATIONAL
Enrollment
116
Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique
Knee Society Score
The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery The Knee Society Score consists of an objective score (0-100 points) and a score for function (0-100 points). A higher score means a better outcome.
Time frame: 2 years
Radiographic evaluation of lucent lines
The second endpoint of interest is the incidence of lucent lines measured in millimeters by means of standard X-rays.
Time frame: 6-12 weeks - 10 years
Adverse Events and Complications
Documentation of complication(s): \- Description of complication with the UKA Documentation of component revision(s) (Adverse Events): * Reason(s) for revision(s) * Revised component(s)
Time frame: 6-12 weeks - 10 years
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