ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population (NCT03153449) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
United States400 participantsStarted 2017-09-19
Plain-language 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 complex primary total knee arthroplasty.
Who can participate
Age range22 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
✓. The decision to have knee replacement with the study device is regardless of the research.
✓. The devices are to be used according to the approved indications.
✓. 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 PROMs in either English or one of the available translations.
✓. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)
Exclusion criteria
✕. The Subject is a woman who is pregnant or lactating.
✕. 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.
✕. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) 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 his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.