ATTUNE Cementless FB Tibial Base Clinical Study

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04630262
• Other study ID #: DSJ_2019_05
• Status: Terminated
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.

2. 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.

3. 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.

4. Subject is currently not bedridden.

5. 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.

6. 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• ATTUNE Cementless CR Fixed Bearing
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and CR or (Medial Stabilized) MS Tibial Insert.
• ATTUNE Cementless PS Fixed Bearing
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and PS Tibial Insert.

Locations

Country	Name	City	State
United States	Anderson Clinic	Alexandria	Virginia
United States	Johns Hopkins Orthpaedic Surgery	Baltimore	Maryland
United States	Rubin Institute for Advanced Orthopedics	Baltimore	Maryland
United States	Towson Orthopaedic Associates	Baltimore	Maryland
United States	Coastal Orthopedics	Bradenton	Florida
United States	American Hip Institute & Orthopedic Specialists	Chicago	Illinois
United States	University of Missouri	Columbia	Missouri
United States	Florida Orthopaedic Associates	DeLand	Florida
United States	University of Florida	Gainesville	Florida
United States	Orlin & Cohen Orthopedics	Garden City	New York
United States	Orthopaedic Associates of Michigan	Grand Rapids	Michigan
United States	Orthopaedic Specialty Institute	Irvine	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Mercy Clinic Springfield	Ozark	Missouri
United States	University Orthopaedic Associates, LLC	Somerset	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	Kaplan-Meier Implant Survivorship	Number/rate of subjects with all implants remaining implanted at the 1 year timepoint.	1 Year
Secondary	Kaplan-Meier Implant Survivorship	Number/rate of subjects with all implants remaining implanted at the 2 year timepoint.	2 Years
Secondary	Kaplan-Meier Implant Survivorship	Number/rate of subjects with all implants remaining implanted at the 5 year timepoint.	5 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Investigator-conducted Radiographic Analysis	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.	6 weeks or 6 months
Secondary	Investigator-conducted Radiographic Analysis	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.	1 Year
Secondary	Investigator-conducted Radiographic Analysis	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.	2 Years
Secondary	Investigator-conducted Radiographic Analysis	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.	5 Years