Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is described as 'non-interventional,' meaning it's observing outcomes of the oneKNEE® implant rather than testing a new treatment — so does that mean I would simply receive the knee replacement as planned and then be followed over time, or would there be any additional procedures or visits beyond my normal care?
2Since this study is not yet recruiting, how long might it be before it actually opens, and would waiting to participate affect my treatment timeline or access to the oneKNEE® implant?
3One of the things being tracked is prosthetic joint infection — can you tell me what the known risks of infection are with this specific implant, and how does that compare to other knee replacement options I might consider?
4Because this is a post-market follow-up study rather than a randomized controlled trial, what does that mean for how confident we can be in the safety and performance data it will generate, and how should that factor into my decision?
5If I were to participate, what would the long-term follow-up commitment look like in terms of clinic visits, questionnaires, or check-ins, and is that realistic given my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of the implant
Timeframe: 2 years after implantation
2
Clinical Performance in terms of clinical outcome of oneKNEE®