Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New knee implant tracked for 10 years – will it last?

NCT ID NCT03078543

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
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This status has not been confirmed recently, so it may be out of date.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 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.

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

148 people

The number who actually took part.

Started

Jun 2017

Expected to finish

Apr 2029

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

Subjects undergoing primary total knee arthroplasty.

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 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Arthroplasty, replacement, knee are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Beijing Jishuitan Hospital, Institute of Orthopedics & Traumatology,

    Beijing, Beijing Municipality, 100035, China

  • Chonnam National University Hwasun Hospital

    Hwasan, South Korea

  • Fatebenefratelli Isola Tiberina Gemelli Hospital - Isle of Rome

    Roma, 00186, Italy

  • Instituto Clinico Sant'Ambrogio

    Milan, Milan, 20149, Italy

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam, 626-770, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Siriraj Hospital

    Bangkok, Bangkok, 10700, Thailand

  • Westville Hospital

    Durban, KwaZulu-Natal, 3630, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.