Safety and Efficacy of the ANTHEM™ CR Total Knee System (NCT03885622) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy of the ANTHEM™ CR Total Knee System
India, Italy, South Africa153 participantsStarted 2018-11-23
Plain-language summary
This clinical study will evaluate the short-term (1- and 2-year) and medium term (5-year) safety and performance of the ANTHEM™ CR Total Knee System in patients with non-inflammatory degenerative joint disease of the knee requiring total knee replacement. Clinical, radiographic, Health Economic Outcomes and safety outcomes will be evaluated.
Who can participate
Age range
18 Years – 75 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 is a candidate for primary total knee arthroplasty due to degenerative joint disease.
. Subject is willing to sign and date an EC-approved consent form.
. Subject has posterior cruciate ligament and all collateral ligaments intact in the index joint.
. Subject is 18 to 75 years old at time of inclusion.
. Subject plans to be available through ten (10) years postoperative follow-up.
. Subject agrees to follow the study protocol.
. Subject has achieved skeletal maturity as deemed by enrolling investigator.
Exclusion criteria
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 would receive the ANTHEM™ CR Total Knee System on the affected knee as a revision for a previously failed (TKA) or unicondylar knee arthroplasty (UKA).
. Subject received TKA on the contralateral knee as a revision for a previously failed TKA or UKA.
. Subject has a history of patellar fracture, patellectomy, or patello-femoral Instability.
. Subject has inflammatory arthritis.
. Subject possesses a contralateral or ipsilateral revision hip arthroplasty.
. Subject has ipsilateral hip arthritis resulting in flexion contracture.
. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:
. Inadequate bone stock which would make the procedure unjustifiable including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia as deemed by the enrolling investigator.