ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Launched by DEPUY ORTHOPAEDICS · May 12, 2017
Trial Information
Current as of June 04, 2025
Recruiting
Keywords
ClinConnect Summary
The ATTUNE® Revision trial is a study looking at a specific type of knee replacement surgery called total knee arthroplasty. This study is testing a new knee prosthesis, which is an artificial joint designed to replace damaged parts of the knee. The aim is to see how well this device works over five years in patients who have complex needs for knee surgery. The trial is currently recruiting participants aged 22 to 80 who are considering knee replacement surgery, and who are generally healthy and able to participate in follow-up visits.
To be eligible for the study, participants must be able to understand the trial and provide written consent. They should not have certain medical conditions, like inflammatory arthritis, or have had previous knee surgeries on the same knee. If someone joins the study, they can expect to receive the knee replacement and be monitored for five years to assess how well the knee is functioning and their overall recovery. This trial is important because it aims to gather valuable information that could help improve knee replacement surgeries for future patients.
Gender
ALL
Eligibility criteria
- 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.).
- • -
About Depuy Orthopaedics
DePuy Orthopaedics, a subsidiary of Johnson & Johnson, is a leading global provider of orthopedic medical devices, specializing in the development, manufacturing, and marketing of innovative solutions for joint reconstruction, trauma, and spinal care. With a commitment to advancing patient outcomes through cutting-edge technology and evidence-based practices, DePuy Orthopaedics actively engages in clinical trials to evaluate the safety and efficacy of its products. The company collaborates with healthcare professionals and institutions to ensure that its offerings meet the highest standards of quality and effectiveness, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lebanon, New Hampshire, United States
Jackson, Mississippi, United States
Maastricht, , Netherlands
Middlesbrough, , United Kingdom
Denver, Colorado, United States
Wellington, , New Zealand
Columbus, Ohio, United States
Egg Harbor Township, New Jersey, United States
Austin, Texas, United States
Houston, Texas, United States
Wigan, , United Kingdom
Fort Collins, Colorado, United States
London, Ontario, Canada
Oxford, , United Kingdom
Linz, , Austria
Basingstoke, , United Kingdom
San Diego, California, United States
Rennes, , France
Niantic, Connecticut, United States
Deland, Florida, United States
Louisville, Kentucky, United States
Ozark, Missouri, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Nashville, Tennessee, United States
Adelaide, , Australia
Perth, , Australia
Antwerp, , Belgium
Winnipeg, , Canada
Munich, , Germany
Schwandorf, , Germany
Cork, , Ireland
Verona, , Italy
Basel, , Switzerland
Kirkcaldy, , United Kingdom
Leeds, , United Kingdom
Oswestry, , United Kingdom
Patients applied
Trial Officials
Grant Jamgochian
Study Director
Sponsor GmbH
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials