Persona Ti-Nidium Post-Market Clinical Follow-up (NCT04817969) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Persona Ti-Nidium Post-Market Clinical Follow-up
United States240 participantsStarted 2021-06-01
Plain-language summary
The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
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 of legal age and skeletally mature
. Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document
. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
. Patient qualifies for total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Ti-Nidium Knee System and Vivacit-E polyethylene articulating surface
. Independent of study participation, patient is a candidate for the commercially available Persona Ti-Nidium Knee and Vivacit-E polyethylene articulating surface, implanted in accordance with product labeling
. Collagen disorders, and/or avascular necrosis of the femoral condyle.
. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Exclusion criteria
. Patient is unwilling to sign the Informed Consent
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.
. Patient is currently participating in any other surgical intervention or pain management study
. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
. Insufficient bone stock on femoral or tibial surfaces