ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

  • STATUS
    Recruiting
  • End date
    Mar 31, 2029
  • participants needed
    400
  • sponsor
    DePuy Orthopaedics
Updated on 16 September 2021

Summary

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.

Description

The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship.

The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed.

Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.

Details
Condition Revision Total Knee Arthroplasty
Treatment ATTUNE Revision Knee System in Revision Total Knee Arthroplasty
Clinical Study IdentifierNCT03153475
SponsorDePuy Orthopaedics
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive
Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or prior revision TKA that requires a revision procedure of implanted tibial and/or femoral components
The decision to perform a knee revision with the study device is regardless of the research
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
The devices are to be used according to the approved indications.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

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
Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive RTKA
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 his/her 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 activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease)
Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator
Uncontrolled gout
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