Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07682909). StuddyBuddy aggregates publicly available trial information.