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Evaluation of ATTUNE Revision Knee System in Complex Primary Knee Replacement

Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty

NA · DePuy Orthopaedics · NCT03153449

This study is testing a new knee replacement system to see how well it works for people with complex knee issues and high body weights over five years.

Quick facts

PhaseNA
Study typeInterventional
Enrollment400 (estimated)
Ages22 Years to 80 Years
SexAll
SponsorDePuy Orthopaedics (industry)
Locations37 sites (San Diego, California and 36 other locations)
Trial IDNCT03153449 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical performance and survivorship of the ATTUNE Revision total knee prostheses in patients undergoing complex primary total knee arthroplasty. It is a five-year, prospective, multi-center, non-randomized, non-controlled study that will enroll approximately 400 subjects across various sites. The study focuses on patients with high BMIs, advanced deformities, and ligamentous laxity, who may require additional surgical components. The primary endpoint is the KOOS-ADL score at two years post-operation, which assesses activities of daily living.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 22-80 who need a primary knee arthroplasty due to deformity, instability, or bone loss.

Not a fit: Patients with inflammatory arthritis or those who are bedridden may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve outcomes for patients requiring complex knee arthroplasty procedures.

How similar studies have performed: Other studies have shown promising results with similar knee arthroplasty approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.).

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Where this trial is running

San Diego, California and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Primary Knee Arthroplasty, complex primary, deformity, ligamentous laxity

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.