ATTUNE Cementless FB Tibial Base Clinical Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-Center Clinical Investigation of the ATTUNE® Cementless Fixed Bearing Tibial Base and Cementless Patella Implants in Total Knee Arthroplasty

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Device: ATTUNE Cementless CR Fixed Bearing
* Device: ATTUNE Cementless PS Fixed Bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive. Subject has a severely painful knee and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant provided that adequate bone is present. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor. Subject is currently not bedridden. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures. Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations. Exclusion Criteria: a) The Subject is a woman who is pregnant or lactating. b) Contralateral knee has already been enrolled in this study . c) Revision knee that was previously enrolled in the study as a primary knee (ipsilateral). d) Subject has participated in a clinical study with an investigational product (drug or device) in the last two (2) years. e) Subject has had surgery on their contralateral knee within six (6) months of study enrolment or has surgery planned on their contralateral knee less than six (6) months of the study surgery. f) Subject is suffering from inflammatory arthritis in any joint (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.). g) Active local or systemic infection. h) Loss of bone or musculature, inadequate bone quality (e.g. severe osteoporosis), neuromuscular compromise or vascular deficiency at the bone site in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures that could lead to implant instability, joint neuropathy). i) Severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity. j) The inability to make bone cuts (e.g. inadequate bone stock) so as to assure correct component position, a firm press fit, and intimate apposition of the cut bone and prosthetic surfaces. k) Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. l) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last five 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: ATTUNE Cementless Fixed Bearing
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ATTUNE Cementless CR Fixed Bearing<br>Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Cruciate Retaining Configuration. | Device: ATTUNE Cementless CR Fixed Bearing<br>* Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and CR or (Medial Stabilized) MS Tibial Insert.<br>|
| Active Comparator: ATTUNE Cementless PS Fixed Bearing<br>Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Posterior Stabilizing Configuration. | Device: ATTUNE Cementless PS Fixed Bearing<br>* Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and PS Tibial Insert.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Responder Rate of first 225 Subjects | A functional responder is defined as a subject that shows at least 20% improvement in Knee Injury and Osteoarthritis Outcome Score (KOOS) from baseline and at least a 10 point improvement in at least two of the following: KOOS Activities of Daily Living, KOOS Pain, and KOOS Quality of Life. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of Adverse Events | An Adverse Event (AE) is Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to a medical device. This measure will assess the type of AEs reported throughout the duration of the study. | Through study completion or 5 years. | 
| Frequency of Adverse Events | An Adverse Event (AE) is Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to a medical device. This measure will assess the frequency of AEs reported throughout the duration of the study. | Through study completion or 5 years. | 
| Type of Device Deficiencies | A Device Deficiency (DD) is inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, such as malfunction, misuse, use error or inadequacy in information supplied by the manufacturer. This measure will assess the type of DDs reported throughout the duration of the study. | Through study completion or 5 years. | 
| Frequency of Device Deficiencies | A Device Deficiency (DD) is inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, such as malfunction, misuse, use error or inadequacy in information supplied by the manufacturer. This measure will assess the frequency of DDs reported throughout the duration of the study. | Through study completion or 5 years. | 
| Functional Responder Rate All Subjects | A functional responder is defined as a subject that shows at least 20% improvement in Knee Injury and Osteoarthritis Outcome Score (KOOS) from baseline and at least a 10 point improvement in at least two of the following: KOOS Activities of Daily Living, KOOS Pain, and KOOS Quality of Life. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 1 Year | 
| Kaplan-Meier Implant Survivorship | Number/rate of subjects with all implants remaining implanted at the 1 year timepoint. | 1 Year | 
| Kaplan-Meier Implant Survivorship | Number/rate of subjects with all implants remaining implanted at the 2 year timepoint. | 2 Years | 
| Kaplan-Meier Implant Survivorship | Number/rate of subjects with all implants remaining implanted at the 5 year timepoint. | 5 Years | 
| 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. The max score can be greater than 100 and the min score can be less than 0. | 6 weeks | 
| 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. The max score can be greater than 100 and the min score can be less than 0. | 6 months | 
| 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. The max score can be greater than 100 and the min score can be less than 0. | 1 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. The max score can be greater than 100 and the min score can be less than 0. | 2 years | 
| 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. The max score can be greater than 100 and the min score can be less than 0. | 5 years | 
| 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 maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 6 weeks | 
| 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 maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 6 months | 
| Knee Injury and Osteoarthritis Outcomes Score (KOOS) | A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 1 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 maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 2 years | 
| 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 maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms. | 5 years | 
| 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. | 6 weeks | 
| 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. | 6 months | 
| 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. | 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. | 2 years | 
| 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. | 5 years | 
| 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. | 6 weeks | 
| 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. | 6 months | 
| 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. | 1 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. | 2 Years | 
| 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. | 5 Years | 
| Investigator-conducted Radiographic Analysis | Rate of radiolucencies and other significant radiographic findings identified by clinical investigators. | 6 weeks or 6 months | 
| Investigator-conducted Radiographic Analysis | Rate of radiolucencies and other significant radiographic findings identified by clinical investigators. | 1 Year | 
| Investigator-conducted Radiographic Analysis | Rate of radiolucencies and other significant radiographic findings identified by clinical investigators. | 2 Years | 
| Investigator-conducted Radiographic Analysis | Rate of radiolucencies and other significant radiographic findings identified by clinical investigators. | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Post-traumatic arthritis, Failed total knee, Knee, Total knee arthroplasty