Knee Arthropathy
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEbalanSys UNI
Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique
Sponsors
Mathys Ltd Bettlach
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events and Complications | 6-12 weeks - 10 years | 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) |
| Radiographic evaluation of lucent lines | 6-12 weeks - 10 years | The second endpoint of interest is the incidence of lucent lines measured in millimeters by means of standard X-rays. |
Outcome results
None listed