oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study

oneKNEE - Prospective, Non-interventional, Multicenter Post-Market Clinical Follow-Up Study

Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.

Safety and Clinical Performance will be observed:

Safety: All adverse device effects: serious and non-serious adverse events with relation to either the product or the surgical procedure.

Clinical Performance: Difference in Oxford Knee Score (OKS) 2 years after implantation compared to preoperative state.

Inclusion Criteria:

• Patient age ≤ 80 years
• Indication for a total knee replacement with one of the variants
• Written informed consent
• Willingness and mental ability to participate at the long-term follow-up examinations

Exclusion Criteria:

• Contraindications acc. to the Instructions for Use (IFU)
• Patient age < 18 years
• Known pregnancy
• BMI > 40
• Secondary gonarthrosis (e.g. rheumatoid arthritis, post-traumatic)
• Patients classified as high risk (ASA class >3)
• Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
• Preoperative: aHKA > 190° or aHKA < 170°
• Preoperative: aHKA > 190° or aHKA < 170°[KB1.1][HO1.2][KB1.3][HO1.4]
• Patients held in a custodial setting und - Patients in a relationship of dependence on the sponsor, the clinic or the investigator