New knee implant tracked for 10 years – will it last?
NCT ID NCT03078543
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 148 people with knee osteoarthritis who received the ANTHEM total knee replacement system. Researchers will check how well the implant holds up over 10 years by measuring survival rates and patient-reported knee function. The goal is to confirm the device is as safe and effective as other knee implants already on the market.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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148 people
The number who actually took part.
- Started
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Jun 2017
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Subjects undergoing primary total knee arthroplasty.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Jishuitan Hospital, Institute of Orthopedics & Traumatology,
Beijing, Beijing Municipality, 100035, China
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Chonnam National University Hwasun Hospital
Hwasan, South Korea
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Fatebenefratelli Isola Tiberina Gemelli Hospital - Isle of Rome
Roma, 00186, Italy
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Instituto Clinico Sant'Ambrogio
Milan, Milan, 20149, Italy
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Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam, 626-770, South Korea
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Severance Hospital, Yonsei University Health System
Seoul, South Korea
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Siriraj Hospital
Bangkok, Bangkok, 10700, Thailand
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Westville Hospital
Durban, KwaZulu-Natal, 3630, South Africa
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Other studies related to the condition(s) this trial covers.
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