ANTHEM™ PS Total Knee System implant: The ANTHEM™ PS Total Knee System is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties. The ANTHEM™ PS Total Knee System consists of the following components:
* Cobalt-Chrome (Co-Cr) femoral components - Posterior stabilised
* Titanium primary tibial components
* Posterior-stabilised ultra-high molecular weight polyethylene (UHMWPE)
* Polyethylene patella components The resulting product is sufficient to accommodate a wide range of clinical applications.
Study summary
The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease
2. Subject is willing to sign and date an EC-approved consent form
3. Subject is male or female between the ages of 18 and 75 years of age
4. Subject plans to be available through ten (10) years post-operative follow-up
5. Subject agrees to follow the study protocol
Exclusion Criteria:
1. Subject would receive the ANTHEM™ Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
2. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
3. Subject has a history of patellar fracture, patellectomy, patello-femoral instability
4. Subject has inflammatory arthritis
5. Subject possesses a contralateral or ipsilateral revision hip arthroplasty
6. Subject has ipsilateral hip arthritis resulting in flexion contracture
7. 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
8. Subject has an active infection or sepsis (treated or untreated)
9. Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated
10. Subject has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes mellitus i.e. not under treatment with oral/injectable medications to control blood glucose levels, fibromyalgia, moderate to severe renal insufficiency or neuromuscular disease)
11. Subject has a chronic, contralateral lower extremity condition causing abnormal ambulation, which is not related to the knee (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
12. Subject is pregnant or plans to become pregnant during the study
13. Subject 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
14. Subject has a BMI\>40
15. Subject is enrolled in another investigational drug, biologic, or device study
16. Subject is facing current or impending incarceration
17. Subject has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia
Primary outcome measure(s)
Ten year Anthem knee implant survivorship — Study participants will be followed for 10 years The ANTHEM™ Total Knee System will demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
Trial sites (8)
Facility
City
Region
Status
Beijing Jishuitan Hospital, Institute of Orthopedics & Traumatology,
Beijing
Beijing Municipality
Instituto Clinico Sant'Ambrogio
Milan
Milan
Fatebenefratelli Isola Tiberina Gemelli Hospital - Isle of Rome
Roma
Italy
Westville Hospital
Durban
KwaZulu-Natal
Pusan National University Yangsan Hospital
Yangsan
Gyeongsangnam
Chonnam National University Hwasun Hospital
Hwasan
South Korea
Severance Hospital, Yonsei University Health System
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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