Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty (NCT03720782) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty
United States118 participantsStarted 2019-05-22
Plain-language summary
The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants for 10 years post-surgery.
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
. Subject received primary TKA with the LEGION Porous HA Tibial Baseplates (either with holes or without holes) and/or the LEGION Porous HA CR Femoral Component, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, or degenerative arthritis).
. Subject received primary TKA between 24 and 60 months prior to the time of consent.
. Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form.
. Subject must be available through ten (10) years postoperative follow-up.
. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English.
Exclusion criteria
. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
. Subject has ipsilateral hip arthritis resulting in flexion contracture.
. At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; Contralateral primary total knee or unicondylar knee arthroplasty.
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.
. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
. Subject has a known allergy to one or more of its components of the study device.
. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.