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Will your new knee last 15 years? study tracks attune implant survivorship

NCT ID NCT01754363

Knowledge-focused Sponsor: DePuy International 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study follows over 1,500 people who received an Attune total knee replacement to see how long the implant lasts—up to 15 years. Participants had non-inflammatory degenerative joint disease (like osteoarthritis). The goal is to gather real-world data on the durability of four different knee configurations, helping doctors and patients choose the best option.

What this could mean

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

Active substance
Attune Primary Total Knee Replacement (a medical device)
What this could lead to
If successful, this study will provide reliable data on how long the Attune knee implant lasts, helping surgeons and patients make informed choices.
What could go wrong
This is an observational follow-up study, not a test of a new treatment. Results may vary by patient and implant configuration, and long-term data may not apply to all users.

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

1,542 people

The number who actually took part.

Started

Feb 2013

Expected to finish

Feb 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 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: * Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive. * Subject was diagnosed with NIDJD. * Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae. * Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy. * Subject is currently not bedridden. * Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures. * Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol. * The devices specified in this protocol were implanted. Exclusion Criteria: * Subject is a woman who is pregnant or lactating. * Contralateral knee has already been enrolled in this study. * Subject had a contralateral amputation. * Previous partial knee replacement (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. * Subject is currently experiencing radicular pain from the spine. * Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months. * Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. * Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires. * Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication. * Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease). * Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, etc.). * Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol. * Subject has a medical condition with less than 5 years of life expectancy.

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Conditions

The condition(s) this trial relates to.

osteoarthritis

As listed by the trial registrant

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

Noninflammatory degenerative joint disease

Contacts and locations

Locations

  • Ascot Hospital

    Auckland, New Zealand

  • Canberra Hospital-Trauma & Orthopaedic Research Unit

    Adelaide, South Australia, ACT 2600, Australia

  • Center for Hip and Knee Surgery

    Mooresville, Indiana, 46158, United States

  • Clifton Park NHS Treatment Centre

    York, YO30 5RA, United Kingdom

  • Florida Research Associates, LLC

    DeLand, Florida, 32720, United States

  • Krankenhaus der Barmherzigen

    Linz, Upper Austria, 4010, Austria

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259, United States

  • Monica Camputs O.L.V. Middelares

    Antwerp, 2100, Belgium

  • New Royal Infirmary of Edinburgh

    Edinburgh, Scotland, EH16 4SA, United Kingdom

  • OrthoNeuro

    New Albany, Ohio, 43054, United States

  • Orthopaedic Specialty Institute

    Orange, California, 92868, United States

  • Orthopedic One

    Columbus, Ohio, 43213, United States

  • Orthopädische Klinik für die Universität Regensburg

    Bad Abbach, Bavaria, 3077, Germany

  • Penn State Hershey Bone & Joint Institute

    Hershey, Pennsylvania, 17033, United States

  • Princess Alexandria Hospital

    Harlow, CM20 1QX, United Kingdom

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Queen Mary Hospital

    Dunfermline, Fife, KY12 OSU, United Kingdom

  • Robert Jones & Agnes Hunt Orthopaedic Hospital

    Gobowen, Oswestry, SY10 7AG, United Kingdom

  • Seoul National University Boramae Hospital

    Seoul, Dongjak-gu, 156-707, South Korea

  • Seoul National University Hospital

    Seoul, 110-714, South Korea

  • Singapore General Hospital-Dept of Orthopaedic Surgery

    Singapore, 169608, Singapore

  • Texas Institute for Hip and Knee Surgery, LLC

    Austin, Texas, 78705, United States

  • Univ.-Klinik für Orthopädie

    Vienna, Lower Austria, 1090, Austria

  • UniversitatsKlinikum Heidelberg

    Heidelberg, 69118, Germany

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

  • University of Western Ontario-Department of Orthopaedic Surgery

    London, Ontario, N6A 5A5, Canada

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