Cementless Total Knee Arthroplasty: Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)
Study summary
The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
Eligibility
Sex
ALL
Min age
22 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
* Subject was diagnosed with NIDJD.
* Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
* 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 PROs 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.
* Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy 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 their 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 (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
* Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
* Subject has a medical condition with less than five (5) years life expectancy.
* Uncontrolled gout
Primary outcome measure(s)
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL) — Minimum 2 years (670-1033 days after surgery) The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Trial sites (20)
Facility
City
Region
Status
Colorado Joint Replacement
Denver
Colorado
Florida Research Associates
DeLand
Florida
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
New London Hospital
New London
New Hampshire
Rothman Institute
Egg Harbor
New Jersey
SUNY downstate Medical Center
Brooklyn
New York
UNC Chapel Hill
Chapel Hill
North Carolina
Associated Orthopaedics of Kingsport
Kingsport
Tennessee
Texas Tech University Heath Science Center
Lubbock
Texas
Hampton Roads Orthopaedics and Sports Medicine
Newport News
Virginia
Krankenhaus der Barmherzigen Schwestern Ried im Innkreis
Ried im Innkreis
Upper Austria
Foothills Medical Centre, University of Calgary
Calgary
Alberta
CHU de la Cavale Blanche
Brest
Cedex
Sevice de Chirurgie Orthoedique et Traumatologique
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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