ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
- Conditions
- Revision Total Knee Arthroplasty
- Interventions
- Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty
- Registration Number
- NCT03153475
- Lead Sponsor
- DePuy Orthopaedics
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ATTUNE Revision Knee System ATTUNE Revision Knee System in Revision Total Knee Arthroplasty The ATTUNE Revision system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in revision knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets
- Primary Outcome Measures
Name Time Method Survivorship 5 Years To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB and PS RP configurations.
- Secondary Outcome Measures
Name Time Method Tibial component alignment 1, 2 and 5 years Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Patient's Knee Implant Performance (PKIP) Baseline, 2 and 5 yr timepoints Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure (overalll and subscores)
American Knee Society Score Baseline, 2 year, 5 year Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure
Survivorship 1, 2, 3 and 4 years Evaluate survivorship of the ATTUNE® Revision TKA system for the PS FB and PS RP configurations and the combined PS FB and PS RP configurations using Kaplan-Meier survival analysis at 1, 2, 3, and 4 years.
Frequency of radiolucent line occurrence 1, 2 and 5 years Evaluate ATTUNE® Revision TKA fixation through zonal radiographic analysis of the bone-implant interface at 1, 2 and 5 years after surgery compared to the first postoperative radiographs.
Restoration of joint line First post-operative radiograph (1 day) Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.
Adverse Events Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs. Evaluate type and frequency of Adverse Events
Anatomic Tibiofemoral Alignment 1, 2 and 5 years Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
EQ-5D-5L Baseline, 2 year and 5 year Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the EQ-5D-5L patient reported outcome measures
VAS Pain Score Baseline, 2 year and 5 year Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).
Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS) Baseline, 2 year and 5 Year Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the KOOS-PS patient reported outcome measures
Patient Satisfaction Baseline, 2 year and 5 year Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.
Readmissions 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
femoral component alignment 1, 2 and 5 years Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Trial Locations
- Locations (38)
Fondren Orthopedic Group
🇺🇸Houston, Texas, United States
Scripps Clinic Torrey Pines
🇺🇸San Diego, California, United States
Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology
🇨🇭Basel, Switzerland
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
🇦🇹Linz, Austria
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Southern Joint Replacement Institute
🇺🇸Nashville, Tennessee, United States
Colorado Joint Replacement
🇺🇸Denver, Colorado, United States
Orthopaedic Center of the Rockies
🇺🇸Fort Collins, Colorado, United States
Florida Orthopedic Associates
🇺🇸DeLand, Florida, United States
Mery Hospital
🇺🇸Ozark, Missouri, United States
Rothman Institute
🇺🇸Egg Harbor Township, New Jersey, United States
UNC Orthopaedics
🇺🇸Chapel Hill, North Carolina, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Texas Institute for Hip & Knee Surgery
🇺🇸Austin, Texas, United States
The Gold Coast Centre for Bone and Joint Surgery
🇦🇺Gold Coast, Australia
St. John of God Murdoch Hospital
🇦🇺Perth, Australia
MoRe Foundation
🇧🇪Antwerp, Belgium
Concordia Joint Replacement
🇨🇦Winnipeg, Canada
London Health Sciences Centre University Hospital
🇨🇦London, Ontario, Canada
CHRU La Cavale Blanche
🇫🇷Brest, France
Asklepios Orthopädische Klinik Lindenlohe
🇩🇪Schwandorf, Germany
Centre Hospitalier Universitaire de Rennes
🇫🇷Rennes, France
South Infirmary Public Hospital
🇮🇪Cork, Ireland
University Hospital Maastricht
🇳🇱Maastricht, Netherlands
CLINICHE GAVAZZENI SPA aka Humanitas Castelli
🇮🇹Bergamo, Italy
Wellington Hospital
🇳🇿Wellington, New Zealand
Hampshire Hospitals NHS Foundation Trust
🇬🇧Basingstoke, United Kingdom
Chapel Allerton Orthopaedic Centre
🇬🇧Leeds, United Kingdom
James Cook University Hospital
🇬🇧North Yorkshire, United Kingdom
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
🇬🇧Oswestry, United Kingdom
Nuffield Orthopaedic Centre
🇬🇧Oxford, United Kingdom
Wrightington Hospital
🇬🇧Wigan, United Kingdom
OrthoCarolina Hip and Knee Center
🇺🇸Charlotte, North Carolina, United States
Orthopedic Partners
🇺🇸Niantic, Connecticut, United States
Arthroplasty Foundation
🇺🇸Louisville, Kentucky, United States
Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche
🇩🇪Munich, Germany
Victoria Hospital NHS Fife
🇬🇧Kirkcaldy, United Kingdom