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.
Within primary TKA, there are factors that lead to more complex procedures that include patients with high BMIs, advanced preoperative deformities and ligamentous laxity. Such cases may require the surgeon to treat using ancillary components, such as stems and/or augments and/or additional constraint. This post-market study will evaluate the short/medium term clinical performance and medium term survivorship of the ATTUNE Revision system system, which includes instrumentation, in complex primary TKA. The study is designed as a worldwide non-comparative, multi-center study with each site initially having a cohort of approximately 20 Subjects to recruit. The study will enroll approximately 200 fixed bearing and approximately 200 rotating platform configurations. The 2-year KOOS-ADL (activities of daily living) was selected as the primary endpoint because it will evaluate the post-operative period during which outcomes typically plateau and will therefore provide a good indication of longer term outcomes Male and female Subjects, age 22-80 years, inclusive, who require a primary knee arthroplasty in a joint that, due to deformity, instability, bone loss etc., necessitates the use of implants found within the ATTUNE Revision knee system and are suitable candidates for TKA using the ATTUNE® Revision system are eligible for enrollment in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their anatomy is such that the use of revision components are required to perform primary total knee arthroplasty
KOOS ADL
Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB and RP configurations.
Time frame: 2 Years
Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL)
Evaluate change from preoperative baseline to the 5 yr timepoint in functional outcomes as measured using KOOS patient reported outcomes measure (PROM).
Time frame: Baseline, 5 Year
Patient's Knee Implant Performance (PKIP)
Evaluate change from preoperative baseline to 5 yr timepoint in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure
Time frame: Baseline, 5 Year
American Knee Society Score
valuate change from preoperative baseline to 5 yr timepoint in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure
Time frame: Baseline, 5 Year
EQ-5D-5L
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes and quality of life assessments, as measured using the EQ-5D-5L patient reported outcome measure
Time frame: Baseline, 5 year
VAS Pain Score
Evaluate change from preoperative baseline to 5 yr timepoint in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).
Time frame: Baseline, 5 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Scripps Clinic Torrey Pines
San Diego, California, United States
Colorado Joint Replacement
Denver, Colorado, United States
Orthopaedic Center of the Rockies
Fort Collins, Colorado, United States
Orthopedic Partners
Niantic, Connecticut, United States
Florida Orthopedic Associates
DeLand, Florida, United States
Arthroplasty Foundation
Louisville, Kentucky, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rothman Institute
Egg Harbor, New Jersey, United States
UNC Orthopaedics
Chapel Hill, North Carolina, United States
...and 24 more locations
American Knee Society Score
Evaluate change from preoperative baseline to the 5 yr timepoint in patient reported satisfaction from the AKS 2011 over time as measured using a Likert scale.
Time frame: Baseline, 5 year
American Knee Society Score (surgeon evaluation)
Estimate the change from preoperative baseline to the 5 yr timepoint in clinical outcomes using the 2011 AKS (surgeon evaluation)
Time frame: Baseline, 5 year
Adverse Events
Evaluate type and frequency of Adverse Events
Time frame: Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Readmissions
Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
Time frame: 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Survivorship
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, 4 and 5 years.
Time frame: 1, 2, 3, 4 and 5 years
Frequency of radiolucent line occurrence
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.
Time frame: 1, 2 and 5 years
Anatomic Tibiofemoral Alignment
Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Time frame: 1, 2 and 5 years
Femoral component alignment
Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Time frame: 1, 2 and 5 years
Tibial component alignment
Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Time frame: 1, 2 and 5 years
Restoration of joint line
Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.
Time frame: First post-operative radiograph (1 day)