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NCT07682909
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Conditions: Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Enrollment: 1020
Sponsor: Aesculap AG
Summary
Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07682909). StuddyBuddy aggregates publicly available trial information.