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.
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.
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 existing implants need to be removed and replaced.
Survivorship
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.
Time frame: 5 Years
Patient's Knee Implant Performance (PKIP)
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)
Time frame: Baseline, 2 and 5 yr timepoints
Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)
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
Time frame: Baseline, 2 year and 5 Year
American Knee Society Score
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
Time frame: Baseline, 2 year, 5 year
EQ-5D-5L
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
Time frame: Baseline, 2 year and 5 year
VAS Pain Score
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).
Time frame: Baseline, 2 year and 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
Mery Hospital
Ozark, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rothman Institute
Egg Harbor, New Jersey, United States
...and 28 more locations
Patient Satisfaction
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.
Time frame: Baseline, 2 year and 5 year
Adverse Events
Evaluate type and frequency of Adverse Events
Time frame: Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.
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 yrs., 3 yrs., 4 yrs., 5 yrs
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, and 4 years.
Time frame: 1, 2, 3 and 4 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)