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New knee implant system tested for tough first replacements

NCT ID NCT03153449

Disease control Sponsor: DePuy Orthopaedics Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 3 times

Summary

This study is testing the ATTUNE Revision Knee System in 400 people who need a first knee replacement but have complex bone or joint issues. The implant is normally used for revision surgeries, but here it's being used for primary cases. Researchers will track how well patients can do daily activities over 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ATTUNE Revision Knee System (a set of knee implant components)
What this could lead to
If successful, this could show that the ATTUNE Revision System is a safe and effective option for people with complex knee anatomy needing a first knee replacement.
What could go wrong
This is an early-stage, non-randomized study without a comparison group, so results may not prove superiority over other implants. Risks include typical surgical complications like infection, implant loosening, or the need for revision surgery.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

400 people

The number who actually took part.

Started

Sep 2017

Expected to finish

Oct 2030

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.

Ages

22 to 80 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 male or female and between the ages of 22 and 80 years at the time of consent, inclusive. 2. The decision to have knee replacement with the study device is regardless of the research. 3. The devices are to be used according to the approved indications. 4. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor 5. Subject is currently not bedridden. 6. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures. 7. Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations. 8. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.) Exclusion Criteria: 1. The Subject is a woman who is pregnant or lactating. 2. Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study. 3. Subject had a contralateral amputation. 4. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee. 5. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA. 6. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. 7. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. 8. Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements. 9. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. 10. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease). 11. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator. 12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.). \-

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities Joint Instability

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary knee arthroplasty

Contacts and locations

Locations

  • Arthroplasty Foundation

    Louisville, Kentucky, 40215, United States

  • Asklepios Orthopädische Klinik Lindenlohe

    Schwandorf in Bayern, Germany

  • CHRU La Cavale Blanche

    Brest, France

  • Centre Hospitalier Universitaire de Rennes

    Rennes, France

  • Chapel Allerton Orthopaedic Centre

    Leeds, United Kingdom

  • Colorado Joint Replacement

    Denver, Colorado, 80210, United States

  • Concordia Joint Replacement

    Winnipeg, Canada

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Florida Orthopedic Associates

    DeLand, Florida, 32720, United States

  • Fondren Orthopedic Group

    Houston, Texas, 77030, United States

  • Fremantle Hospital

    Fremantle, Australia

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke, United Kingdom

  • James Cook University Hospital

    Middlesbrough, United Kingdom

  • Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche

    Munich, Germany

  • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

    Linz, Austria

  • London Health Sciences Centre University Hospital

    London, Ontario, Canada

  • Nuffield Orthopaedic Centre

    Oxford, United Kingdom

  • OrthoCarolina Hip and Knee Center

    Charlotte, North Carolina, 28207, United States

  • Orthopaedic Center of the Rockies

    Fort Collins, Colorado, 80525, United States

  • Orthopedic Partners

    Niantic, Connecticut, 06357, United States

  • Rothman Institute

    Egg Harbor, New Jersey, 08234, United States

  • Scripps Clinic Torrey Pines

    San Diego, California, 92037, United States

  • South Infirmary Public Hospital

    Cork, Ireland

  • Southern Joint Replacement Institute

    Nashville, Tennessee, 37203, United States

  • St. John of God Murdoch Hospital

    Perth, Australia

  • Texas Institute for Hip & Knee Surgery

    Austin, Texas, 78751, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

    Oswestry, United Kingdom

  • UNC Orthopaedics

    Chapel Hill, North Carolina, 27514, United States

  • University Hospital Maastricht

    Maastricht, Netherlands

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • Victoria Hospital NHS Fife

    Kirkcaldy, United Kingdom

  • Wellington Hospital

    Wellington, New Zealand

  • Wrightington Hospital

    Wigan, United Kingdom