Persona Partial Knee Clinical Outcomes Study (NCT03034811) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Persona Partial Knee Clinical Outcomes Study
United States, Austria, Belgium757 participantsStarted 2017-02-08
Plain-language summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.
Who can participate
Age range
18 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 is at least 18 years of age
* Patient qualifies for knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Partial Knee system.
* Patient has participated in a study-related Informed Consent process
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent form
* Patient is willing and able to complete scheduled study procedures and follow-up evaluations
* Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee, implanted in accordance with product labeling
Exclusion Criteria:
* Patient is currently participating in any other surgical intervention studies or pain management studies
* Infection, sepsis, and osteomyelitis
* Rheumatoid arthritis or other forms of inflammatory joint disease
* Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device
* Full thickness damage to the weight bearing area of the contralateral compartment
* Uncooperative patient or patient with neurologic disorders who is incapable of following directions
* Insufficient bone stock to provide adequate support and/or fixation to the prosthesis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone …
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.