This is a post-market multicentre study that has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision Robotic Assisted Total Knee Arthroplasty up to 10-year follow up.
This study has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision RA-TKA up to 10-year follow up. Prospective data will be collected for this Post Market Clinical Follow up (PMCF) study and the data will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment on annual basis and support presentations at orthopaedic congresses and/or peer-reviewed publication(s). Participants will be selected for recruitment into the study from the general population of participants requiring a primary or revision knee-arthroplasty and considered suitable to receive the Apex Knee System.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
713
Robotic-assisted total knee arthroplasty in femur and tibial first workflows using the BalanceBot to characterize soft tissue balance, and the Apex UltraCongruent (UC) knee implant type
Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex PosteriorStabilized (PS) knee implant type
Flagstaff Bone and Joint
Flagstaff, Arizona, United States
Orthopaedics New England
Middlebury, Connecticut, United States
DeClaire LaMacchia Orthopaedic Institute
Rochester, Michigan, United States
Nyu Langone-Long Island
Garden City, New York, United States
Survivorship
Frequency of device and implant related adverse events and revision surgery to be recorded.
Time frame: 10 Years
Change in KOOS from baseline to 10 years after surgery
Evaluate impact of participants knee surgery, comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores and participants opinion about their knee KOOS ranges from 0 - 100, in which 100 is best.
Time frame: from enrolment to 10 years
Change in UCLA from baseline to 10 years after surgery
Evaluate impact of participants knee surgery, comparing post-operative Knee Injury and University of California Los Angeles (UCLA) activity Scale and measured the participants usual level of activity UCLA ranges from 0 - 10, in which the higher the score the greater the activity
Time frame: from enrolment to 10 years
Change in Promis-10 from baseline to 10 years after surgery
Evaluate impact of participants knee surgery, comparing post-operative Knee Injury and Patient-Reported Outcomes Measurement Information System (PROMIS) and measures the participants physical, mental, and social health. PROMIS-10 ranges from 1 - 67, in which 67 is best.
Time frame: from enrolment to 10 years
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Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex Revision knee implant type
Oklahoma Sports and Orthopedics Institute
Oklahoma City, Oklahoma, United States
Gundersen Health System
La Crosse, Wisconsin, United States