This is a prospective, multi-center, non-randomized, single arm observational study. The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window.
The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window. Study success will be determined using the primary TKA (CR FB and PS FB combined) analysis group. The secondary objectives of this study are to establish the surgical effectiveness of the ATTUNE Cementless Tibial Base by evaluating type and frequency of Adverse Events and Device Deficiencies, functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for all subjects (CR FB and PS FB combined) at the 1-year timepoint, the change from preoperative baseline to the 6-week, 6-month, 1-year, 2-year and 5-year timepoints in functional outcomes and quality of life assessments, as measured using additional patient reported outcomes measures (PROMS), implant survivorship of the ATTUNE Cementless FB Tibial base using Kaplan-Meier survival analysis at 1, 2 and 5-year timepoints, and investigator-conducted radiographic analysis of the tibial and patellar components at 6 weeks/6 months 1, 2 and 5 years after surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and CR or (Medial Stabilized) MS Tibial Insert.
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and PS Tibial Insert.
Orthopaedic Specialty Institute
Irvine, California, United States
Coastal Orthopedics
Bradenton, Florida, United States
One Year Functional Responder Rate of First 225 Subjects
Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia
Time frame: through study completion, up to 10 months
Measure of Knees With Adverse Events
This measure will assess the percentage of knees with reported AEs throughout the duration of the study.
Time frame: Through study completion, up to 10 months
Mean Number of Adverse Events Per Knee for Knees With Reported AEs
This measure will assess the mean number of AEs per Knee for those knees with reported AEs throughout the duration of the study.
Time frame: Through study completion, up to 10 months
Measure of Knees With Device Deficiencies
This measure will assess count of knees with various types of device deficiencies reported throughout the duration of the study.
Time frame: Through study completion, up to 10 months
Mean Number of Device Deficiencies Per Knee
This measure will assess the mean number of device deficiencies (DD) per knee reported throughout the duration of the study.
Time frame: Through study completion, up to 10 months
One Year Functional Responder Rate All Subjects
Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for all subjects.
Time frame: Through study completion, up to 10 months.
One Year Kaplan-Meier Implant Survivorship
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Florida Orthopaedic Associates
DeLand, Florida, United States
University of Florida
Gainesville, Florida, United States
American Hip Institute & Orthopedic Specialists
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Johns Hopkins Orthpaedic Surgery
Baltimore, Maryland, United States
Towson Orthopaedic Associates
Baltimore, Maryland, United States
Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, United States
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States
...and 5 more locations
Number/rate of subjects with all implants remaining implanted at the 1 year timepoint.
Time frame: Through study completion, up to 10 months
Two Year Kaplan-Meier Implant Survivorship
Number/rate of subjects with all implants remaining implanted at the 2- year timepoint.
Time frame: Through study completion, up to 10 months
Five Year Kaplan-Meier Implant Survivorship
Number/rate of subjects with all implants remaining implanted at the 5- year timepoint.
Time frame: Through study completion, up to 10 months
6 Week Knee Society Score
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.
Time frame: Through study completion, up to 6 weeks
6 Month Knee Society Score
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.
Time frame: Through study completion, up to 6 Months
One Year Knee Society Score
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.
Time frame: Through study completion, up to 10 months
Two Year Knee Society Score
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.
Time frame: Through study completion, up to 10 months
Five Year Knee Society Score
Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.
Time frame: Through study completion, up to 10 months
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Time frame: Through study completion, up to 6 weeks
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Time frame: Through study completion, up to 6 Months
One Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Time frame: Through study completion, up to 10 months
Two Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Time frame: Through study completion, up to 10 months
Five Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.
Time frame: Through study completion, up to 10 months
Six Week Forgotten Joint Score (FJS-12)
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Time frame: Through study completion, up to 6 weeks
Six Month Forgotten Joint Score (FJS-12)
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Time frame: Through study completion, up to 6 months
1 Year Forgotten Joint Score (FJS-12)
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Time frame: Through study completion, up to 10 months
Two Year Forgotten Joint Score (FJS-12)
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Time frame: Through study completion, up to 10 months
Five Year Forgotten Joint Score (FJS-12)
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is
Time frame: Through study completion, up to 10 months
Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Time frame: Through study completion, up to 6 weeks
Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Time frame: Through study completion, up to 6 months
One Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Time frame: Through study completion, up to 10 months
Two Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Time frame: Through study completion, up to 10 months
Five Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Time frame: Through study completion, up to 10 months
Six Month Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time frame: Through study completion, up to 6 Months
One Year Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time frame: Through study completion, up to 10 months
Two Year Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time frame: Through study completion, up to 10 months
Five Year Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time frame: Through study completion, up to 10 months