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Clinical Trials in China / NCT03078543
Active, not recruiting Observational

Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System

NCT03078543 · tracked via the Priya Life Science China tracker
Sponsor
Smith & Nephew, Inc.
Phase
Observational
Started
2017-06-28
Last updated
2026-03-11

Condition(s) studied

Arthroplasty, Replacement, Knee

Investigational drug(s) / intervention(s)

ANTHEM™ PS Total Knee System implant

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)

Trial sites (8)

FacilityCityRegionStatus
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 Seoul South Korea
Siriraj Hospital Bangkok Bangkok

More Smith & Nephew, Inc. trials in China

Other trials for the same condition

Official registry record

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.

View NCT03078543 on ClinicalTrials.gov ↗ ← All trials in China