Active, not recruitingNo phase
Survivorship of Attune Primary Total Knee Prosthesis
Key facts
- Who runs it
- DePuy International
- Where
- Austin, Columbus, DeLand, Hershey, Iowa City, Mooresville, New Albany, Orange, and Scottsdale, United StatesSee the 9 sitesAlso in 11 other countries, 18 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 1,542 people enrolled
- Started
- 1 Feb 2013
- Expected to end
- 1 Feb 2030
- Type of study
- Interventional
- Treatments tested
- Attune Primary Total Knee Replacement
- Record updated
- 3 November 2026
Who can take part
- Age
- 22 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous partial knee replacement (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee
- Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months
- Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication
- Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires
- 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 has a medical condition with less than 5 years of life expectancy
- Subject is a woman who is pregnant or lactating
- Contralateral knee has already been enrolled in this study
- Subject had a contralateral amputation
- Subject is currently experiencing radicular pain from the spine
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims
- 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
Where in United States
Also in 11 other countries, 18 sites
- Texas Institute for Hip and Knee Surgery, LLCAustin, United StatesNo longer taking part
- Orthopedic OneColumbus, United StatesNo longer taking part
- Florida Research Associates, LLCDeLand, United StatesNo longer taking part
- Penn State Hershey Bone & Joint InstituteHershey, United StatesNo longer taking part
- University of Iowa Hospitals & ClinicsIowa City, United StatesNo longer taking part
- Center for Hip and Knee SurgeryMooresville, United StatesNo longer taking part
- OrthoNeuroNew Albany, United StatesNo longer taking part
- Orthopaedic Specialty InstituteOrange, United StatesNo longer taking part
- Mayo Clinic - ArizonaScottsdale, United StatesNo longer taking part
About the trial
What the trial wants to find out
This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.
The group in the trial
- Attune Primary Total Knee ReplacementTreatment being tested
Subjects will receive one of the following Attune total knee implants: Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis
- Record updated
- 3 November 2026