14022 ATTUNE Cementless RP Clinical Performance Evaluation
NCT ID: NCT02839850
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
540 participants
INTERVENTIONAL
2016-09-01
2027-09-01
Brief Summary
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Detailed Description
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* Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L.
* Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr.
* Evaluate type and frequency of Adverse Events
* Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.
* Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
* Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ATTUNE Cementless RP TKA
Subjects will receive a cementless, rotating platform total knee arthroplasty
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
80 Years
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Sukhjeet Kaur
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Colorado Joint Replacement
Denver, Colorado, United States
Florida Research Associates
DeLand, Florida, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New London Hospital
New London, New Hampshire, United States
Rothman Institute
Egg Harbor, New Jersey, United States
SUNY downstate Medical Center
Brooklyn, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Associated Orthopaedics of Kingsport
Kingsport, Tennessee, United States
Texas Tech University Heath Science Center
Lubbock, Texas, United States
Hampton Roads Orthopaedics and Sports Medicine
Newport News, Virginia, United States
Krankenhaus der Barmherzigen Schwestern Ried im Innkreis
Ried im Innkreis, Upper Austria, Austria
Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada
CHU de la Cavale Blanche
Brest, Cedex, France
Sevice de Chirurgie Orthoedique et Traumatologique
Salouël, , France
Klinikum Garmisch-Partenkirchen GmbH
Garmisch-Partenkirchen, , Germany
South Infirmary Victoria University Hospital
Cork, , Ireland
Elkerliek Ziekenhuis
Helmond, North Brabant, Netherlands
University of Otago
Christchurch, , New Zealand
Wrightington Hospital
Wigan, Lancashire, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Other Identifiers
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14022
Identifier Type: -
Identifier Source: org_study_id