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New cementless knee implant aims to improve mobility in osteoarthritis patients

NCT ID NCT02839850

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study is testing a new type of knee replacement implant that does not use cement to hold it in place. The implant, called ATTUNE Cementless Rotating Platform, is designed for people with osteoarthritis. Researchers will follow 540 patients for two years to see if their ability to perform daily activities improves after surgery. The study uses patient questionnaires to measure outcomes.

What this could mean

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

Active substance
ATTUNE cementless rotating platform total knee arthroplasty (a knee implant device)
What this could lead to
If successful, this could provide a durable, cement-free knee replacement option that improves mobility and reduces pain for people with osteoarthritis.
What could go wrong
This is an observational device study, not a randomized trial, so results may not prove superiority over existing implants. Risks include implant failure, infection, or 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

About 540 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2016

Expected to finish

Sep 2027

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: * Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive. * Subject was diagnosed with NIDJD. * Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae. * 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 * Subject is currently not bedridden * 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. * Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available translations. Exclusion Criteria: * The 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 (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. * Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA. * Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. * Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. * 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 their ability to complete patient reported questionnaires or be compliant with follow-up requirements. * 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. * Subject has a significant neurological or musculoskeletal disorder(s) 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 erythematosus, etc.). * Subject has a medical condition with less than five (5) years life expectancy. * Uncontrolled gout

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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.

Osteoarthritis

Contacts and locations

Locations

  • Associated Orthopaedics of Kingsport

    Kingsport, Tennessee, 37660, United States

  • CHU de la Cavale Blanche

    Brest, Cedex, 29285, France

  • Colorado Joint Replacement

    Denver, Colorado, 80210, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Elkerliek Ziekenhuis

    Helmond, North Brabant, 5707 HA, Netherlands

  • Florida Research Associates

    DeLand, Florida, 32720, United States

  • Foothills Medical Centre, University of Calgary

    Calgary, Alberta, T2N 2T9, Canada

  • Hampton Roads Orthopaedics and Sports Medicine

    Newport News, Virginia, 23606, United States

  • Klinikum Garmisch-Partenkirchen GmbH

    Garmisch-Partenkirchen, 82467, Germany

  • Krankenhaus der Barmherzigen Schwestern Ried im Innkreis

    Ried im Innkreis, Upper Austria, 4910, Austria

  • New London Hospital

    New London, New Hampshire, 03257, United States

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB, United Kingdom

  • Rothman Institute

    Egg Harbor, New Jersey, 08234, United States

  • SUNY downstate Medical Center

    Brooklyn, New York, 11203, United States

  • Sevice de Chirurgie Orthoedique et Traumatologique

    Salouël, 80480, France

  • South Infirmary Victoria University Hospital

    Cork, T12 X23H, Ireland

  • Texas Tech University Heath Science Center

    Lubbock, Texas, 49416, United States

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Otago

    Christchurch, 8083, New Zealand

  • Wrightington Hospital

    Wigan, Lancashire, WN6 9EP, United Kingdom

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