Back to resultsATTUNE Cementless FB Tibial Base Clinical Study
Primary Purpose
Osteoarthritis of the Knee
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ATTUNE Cementless CR Fixed Bearing
ATTUNE Cementless PS Fixed Bearing
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Post-traumatic arthritis, Failed total knee, Knee, Total knee arthroplasty
Eligibility Criteria
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.
Sites / Locations
- Orthopaedic Specialty Institute
- Coastal Orthopedics
- Florida Orthopaedic Associates
- University of Florida
- American Hip Institute & Orthopedic Specialists
- Loyola University Medical Center
- Johns Hopkins Orthpaedic Surgery
- Towson Orthopaedic Associates
- Rubin Institute for Advanced Orthopedics
- Orthopaedic Associates of Michigan
- University of Missouri
- Mercy Clinic Springfield
- University Orthopaedic Associates, LLC
- Orlin & Cohen Orthopedics
- Anderson Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ATTUNE Cementless CR Fixed Bearing
ATTUNE Cementless PS Fixed Bearing
Arm Description
Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Cruciate Retaining Configuration.
Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Posterior Stabilizing Configuration.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Kaplan-Meier Implant Survivorship
Number/rate of subjects with all implants remaining implanted at the 1 year timepoint.
Kaplan-Meier Implant Survivorship
Number/rate of subjects with all implants remaining implanted at the 2 year timepoint.
Kaplan-Meier Implant Survivorship
Number/rate of subjects with all implants remaining implanted at the 5 year timepoint.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Investigator-conducted Radiographic Analysis
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04630262
Brief Title
ATTUNE Cementless FB Tibial Base Clinical Study
Official Title
Multi-Center Clinical Investigation of the ATTUNE® Cementless Fixed Bearing Tibial Base and Cementless Patella Implants in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was unfunded.
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis, Post-traumatic arthritis, Failed total knee, Knee, Total knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
ATTUNE Cementless Fixed Bearing
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATTUNE Cementless CR Fixed Bearing
Arm Type
Active Comparator
Arm Description
Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Cruciate Retaining Configuration.
Arm Title
ATTUNE Cementless PS Fixed Bearing
Arm Type
Active Comparator
Arm Description
Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Posterior Stabilizing Configuration.
Intervention Type
Device
Intervention Name(s)
ATTUNE Cementless CR Fixed Bearing
Intervention Description
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and CR or (Medial Stabilized) MS Tibial Insert.
Intervention Type
Device
Intervention Name(s)
ATTUNE Cementless PS Fixed Bearing
Intervention Description
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and PS Tibial Insert.
Primary Outcome Measure Information:
Title
Functional Responder Rate of first 225 Subjects
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Type of Adverse Events
Description
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.
Time Frame
Through study completion or 5 years.
Title
Frequency of Adverse Events
Description
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.
Time Frame
Through study completion or 5 years.
Title
Type of Device Deficiencies
Description
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.
Time Frame
Through study completion or 5 years.
Title
Frequency of Device Deficiencies
Description
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.
Time Frame
Through study completion or 5 years.
Title
Functional Responder Rate All Subjects
Description
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.
Time Frame
1 Year
Title
Kaplan-Meier Implant Survivorship
Description
Number/rate of subjects with all implants remaining implanted at the 1 year timepoint.
Time Frame
1 Year
Title
Kaplan-Meier Implant Survivorship
Description
Number/rate of subjects with all implants remaining implanted at the 2 year timepoint.
Time Frame
2 Years
Title
Kaplan-Meier Implant Survivorship
Description
Number/rate of subjects with all implants remaining implanted at the 5 year timepoint.
Time Frame
5 Years
Title
Knee Society Score
Description
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.
Time Frame
6 weeks
Title
Knee Society Score
Description
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.
Time Frame
6 months
Title
Knee Society Score
Description
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.
Time Frame
1 year
Title
Knee Society Score
Description
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.
Time Frame
2 years
Title
Knee Society Score
Description
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.
Time Frame
5 years
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
6 weeks
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
6 months
Title
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Description
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.
Time Frame
1 year
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
2 years
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
5 years
Title
Forgotten Joint Score (FJS-12)
Description
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
6 weeks
Title
Forgotten Joint Score (FJS-12)
Description
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
6 months
Title
Forgotten Joint Score (FJS-12)
Description
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
1 year
Title
Forgotten Joint Score (FJS-12)
Description
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
2 years
Title
Forgotten Joint Score (FJS-12)
Description
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
5 years
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Description
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
6 weeks
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Description
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
6 months
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Description
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
1 Year
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Description
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
2 Years
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Description
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
5 Years
Title
Investigator-conducted Radiographic Analysis
Description
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time Frame
6 weeks or 6 months
Title
Investigator-conducted Radiographic Analysis
Description
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time Frame
1 Year
Title
Investigator-conducted Radiographic Analysis
Description
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time Frame
2 Years
Title
Investigator-conducted Radiographic Analysis
Description
Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Time Frame
5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allyson Morris
Organizational Affiliation
DePuy Synthes
Official's Role
Study Director
Facility Information:
Facility Name
Orthopaedic Specialty Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Coastal Orthopedics
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Florida Orthopaedic Associates
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
American Hip Institute & Orthopedic Specialists
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60018
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Johns Hopkins Orthpaedic Surgery
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Towson Orthopaedic Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Rubin Institute for Advanced Orthopedics
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Orthopaedic Associates of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Mercy Clinic Springfield
City
Ozark
State/Province
Missouri
ZIP/Postal Code
65721
Country
United States
Facility Name
University Orthopaedic Associates, LLC
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Orlin & Cohen Orthopedics
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Anderson Clinic
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
IPD Sharing URL
https://yoda.yale.edu/
Learn more about this trial
ATTUNE Cementless FB Tibial Base Clinical Study
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