New knee replacement system under study for arthritis patients

NCT ID NCT03885622

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

153 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Aug 2034

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Aadhar Health Institute

    Hisar, Haryana, 125001, India

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeonranam-do, 58128, South Korea

  • Gachon University Gil Medical Center

    Incheon, Korea, 21565, South Korea

  • Instituto Clinico Sant'Ambrogio

    Milan, Milan, 20149, Italy

  • Istituto Clinico San Siro

    Milan, 20148, Italy

  • Ivy Hospital - Ivy Elite Institute of Orthopaedics

    Mohali, Punjab, 160071, India

  • Parekhs Hospital

    Ahmedabad, Gujarat, 380015, India

  • Westville Hospital

    Westville, Durban, 3630, South Africa

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