Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique

Conditions
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Knee Arthropathy

Intervention / Treatment
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* Device: balanSys UNI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| balanSys UNI knee prosthesis<br>Participants treated with a balanSys® UNI knee prosthesis | Device: balanSys UNI<br>* Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 6-12 weeks - 10 years |