The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.
Under study are the Persona® Revision Knee System (K181947 and K191625) implants and instrumentation, and any compatible devices being used in conjunction according to the Instructions for Use. This will be accomplished by retrospectively identifying patients who underwent primary or revision TKA with this system and inviting them to participate in prospective data collection at 1, 2, 3, 4, 5, 7, and 10 years postoperative follow-up. As the device was not available for commercial use until late 2019, the retrospective portion will involve those activities that occurred per standard of care for participants. The primary endpoint for this study will be performance assessed by improvement in the 1989 Knee Society Clinical Rating System (KS) objective knee score (KS-KS) from baseline to 2 years (as evaluated using the overall group mean showing at least the Minimal Clinically Important Difference (MCID) of 5.4 points). A maximum of 20 sites will contribute to this study. There will be a maximum of 380 patients enrolled in the study.
Study Type
OBSERVATIONAL
Enrollment
380
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
Advanced Orthopaedic Specialists
Fayetteville, Arkansas, United States
RECRUITINGKnee Society Clinical Rating System objective knee score (KS-KS)
The primary endpoint for this study will be performance assessed by improvement in the 1989 Knee Society Clinical Rating System (KS) objective knee score (KS-KS) from baseline to 2 years (as evaluated using the overall group mean showing at least the minimal clinically important difference \[MCID\] of 5.4 points) The Knee Society objective knee score (KS-KS) assesses the knee joint by awarding points for pain, stability, and range of motion, with a minimum possible score of 0 and maximum possible score of 100. As described in Insall et al. (1989), "100 points will be obtained by a well-aligned knee prosthesis with no pain, \[at least 121\] degrees of motion, and negligible anteroposterior and mediolateral instability."
Time frame: 2 years
Incidence and frequency of adverse events.
Safety of the device will be assessed by evaluating the incidence and frequency of adverse events including (re-)revision of any component during the study in accordance with Regulation (EU) 2017/745 - Medical Device Regulation (MDR) Article 80(2) as well as Medical Devices Coordination Group (MDCG) 2020-10/1.
Time frame: 2 years
Numeric Rating Scale (NRS) Pain Score
Performance and clinical benefits will be assessed by evaluating improvements in patient reported outcome measures (PROMs) of the Numeric Rating Scale (NRS) pain scores from baseline to 2 years. The Numeric Rating Scale (NRS) pain is scored on a scale of 0 to 10. A score of 0 indicates that the patient is experiencing no pain in their knee joint while a score of 10 indicates that the patient is experiencing the worst possible pain in their knee joint.
Time frame: 2 years
Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr)
Performance and clinical benefits will be assessed by evaluating improvements in patient reported outcome measures (PROMs) for the Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) subscale scores from baseline to 2 years. The Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) is scored on a scale of 0 to 100. A score of 100 indicates that a patient is experiencing perfect knee health while a score of 0 indicates that a patient is experiencing total knee disability.
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Bowen Hefley Orthopedics
Little Rock, Arkansas, United States
Community Foundation Medical Group
Fresno, California, United States
WITHDRAWNCornerstone Orthopaedics & Sports Medicine
Superior, Colorado, United States
COMPLETEDOrthopaedic Associates, Inc.
Evansville, Indiana, United States
COMPLETEDJeff Yergler, LLC
Granger, Indiana, United States
RECRUITINGArthroplasty Foundation Inc.
Louisville, Kentucky, United States
COMPLETEDAscension Providence Rochester Hospital
Rochester, Michigan, United States
RECRUITINGMichigan Orthopaedic Surgeons, PLLC
Southfield, Michigan, United States
ACTIVE_NOT_RECRUITINGTRIA Orthopaedic Center Research Institute
Bloomington, Minnesota, United States
COMPLETED...and 6 more locations
Time frame: 2 years