New knee replacement system under study for arthritis patients
NCT ID NCT03885622
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how safe and effective the ANTHEM CR total knee system is for people with non-inflammatory degenerative joint disease who need a total knee replacement. About 153 participants will be followed for up to 10 years to check implant survival, bone health, and any side effects. The goal is to see if this new knee system works as well as or better than existing options.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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153 people
The number who actually took part.
- Started
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Nov 2018
- Expected to finish
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Aug 2034
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
A minimum of 153 subjects undergoing total knee arthroplasty for degenerative joint disease will be implanted with ANTHEM™ CR Total Knee System.
- 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 has posterior cruciate ligament and all collateral ligaments intact in the index joint. 4. Subject is 18 to 75 years old at time of inclusion. 5. Subject plans to be available through ten (10) years postoperative follow-up. 6. Subject agrees to follow the study protocol. 7. Subject has achieved skeletal maturity as deemed by enrolling investigator. Exclusion Criteria: 1. 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). 2. Subject received TKA on the contralateral knee as a revision for a previously failed TKA or UKA. 3. Subject has a history of patellar fracture, patellectomy, or 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 TKA or UKA. 8. 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. 9. Subject has collateral ligament insufficiency. 10. Subject has an active infection or sepsis (treated or untreated) or previous intra-articular infections. 11. Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated. 12. 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). 13. Subject has contralateral lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture). 14. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures. 15. 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. 16. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1. 17. Any subject that meets the definition of a Vulnerable Subject per ISO14155:2011: individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate.
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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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Aadhar Health Institute
Hisar, Haryana, 125001, India
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Chonnam National University Hwasun Hospital
Hwasun, Jeonranam-do, 58128, South Korea
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Gachon University Gil Medical Center
Incheon, Korea, 21565, South Korea
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Instituto Clinico Sant'Ambrogio
Milan, Milan, 20149, Italy
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Istituto Clinico San Siro
Milan, 20148, Italy
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Ivy Hospital - Ivy Elite Institute of Orthopaedics
Mohali, Punjab, 160071, India
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Parekhs Hospital
Ahmedabad, Gujarat, 380015, India
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Westville Hospital
Westville, Durban, 3630, South Africa
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Knee replacement system under the microscope: 5-Year safety check
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- New hip implant under review: will it last?