ATTUNE Cementless FB Tibial Base Clinical Study

Not Applicable

Terminated

Conditions: Osteoarthritis of the Knee

Interventions: Device: ATTUNE Cementless CR Fixed Bearing
Device: ATTUNE Cementless PS Fixed Bearing

Registration Number: NCT04630262

Lead Sponsor: DePuy Orthopaedics

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 80

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATTUNE Cementless CR Fixed Bearing	ATTUNE Cementless CR Fixed Bearing	Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Cruciate Retaining Configuration.
ATTUNE Cementless PS Fixed Bearing	ATTUNE Cementless PS Fixed Bearing	Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Posterior Stabilizing Configuration.

Primary Outcome Measures

Name	Time	Method
One Year Functional Responder Rate of First 225 Subjects	through study completion, up to 10 months	Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia

Secondary Outcome Measures

Name	Time	Method
Measure of Knees With Adverse Events	Through study completion, up to 10 months	This measure will assess the percentage of knees with reported AEs throughout the duration of the study.
Mean Number of Adverse Events Per Knee for Knees With Reported AEs	Through study completion, up to 10 months	This measure will assess the mean number of AEs per Knee for those knees with reported AEs throughout the duration of the study.
Measure of Knees With Device Deficiencies	Through study completion, up to 10 months	This measure will assess count of knees with various types of device deficiencies reported throughout the duration of the study.
Mean Number of Device Deficiencies Per Knee	Through study completion, up to 10 months	This measure will assess the mean number of device deficiencies (DD) per knee reported throughout the duration of the study.
One Year Functional Responder Rate All Subjects	Through study completion, up to 10 months.	Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for all subjects.
One Year Kaplan-Meier Implant Survivorship	Through study completion, up to 10 months	Number/rate of subjects with all implants remaining implanted at the 1 year timepoint.
Two Year Kaplan-Meier Implant Survivorship	Through study completion, up to 10 months	Number/rate of subjects with all implants remaining implanted at the 2- year timepoint.
Five Year Kaplan-Meier Implant Survivorship	Through study completion, up to 10 months	Number/rate of subjects with all implants remaining implanted at the 5- year timepoint.
6 Week Knee Society Score	Through study completion, up to 6 weeks	Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.
6 Month Knee Society Score	Through study completion, up to 6 Months	Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.
One Year Knee Society Score	Through study completion, up to 10 months	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.
Two Year Knee Society Score	Through study completion, up to 10 months	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.
Five Year Knee Society Score	Through study completion, up to 10 months	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.
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)	Through study completion, up to 6 weeks	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.
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)	Through study completion, up to 6 Months	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.
One Year Knee Injury and Osteoarthritis Outcome Score (KOOS)	Through study completion, up to 10 months	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.
Two Year Knee Injury and Osteoarthritis Outcome Score (KOOS)	Through study completion, up to 10 months	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.
Five Year Knee Injury and Osteoarthritis Outcome Score (KOOS)	Through study completion, up to 10 months	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.
Six Week Forgotten Joint Score (FJS-12)	Through study completion, up to 6 weeks	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
Six Month Forgotten Joint Score (FJS-12)	Through study completion, up to 6 months	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)	Through study completion, up to 10 months	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
Two Year Forgotten Joint Score (FJS-12)	Through study completion, up to 10 months	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
Five Year Investigator-conducted Radiographic Analysis	Through study completion, up to 10 months	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Five Year Forgotten Joint Score (FJS-12)	Through study completion, up to 10 months	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
Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L)	Through study completion, up to 6 weeks	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.
Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L)	Through study completion, up to 6 months	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.
One Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)	Through study completion, up to 10 months	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.
Two Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)	Through study completion, up to 10 months	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.
Five Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)	Through study completion, up to 10 months	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.
Six Month Investigator-conducted Radiographic Analysis	Through study completion, up to 6 Months	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
One Year Investigator-conducted Radiographic Analysis	Through study completion, up to 10 months	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.
Two Year Investigator-conducted Radiographic Analysis	Through study completion, up to 10 months	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.

Trial Locations

Locations (15): Orthopaedic Associates of Michigan
🇺🇸
Grand Rapids, Michigan, United States
Towson Orthopaedic Associates
🇺🇸
Baltimore, Maryland, United States
Coastal Orthopedics
🇺🇸
Bradenton, Florida, United States
American Hip Institute & Orthopedic Specialists
🇺🇸
Chicago, Illinois, United States
Florida Orthopaedic Associates
🇺🇸
DeLand, Florida, United States
Orthopaedic Specialty Institute
🇺🇸
Irvine, California, United States
Johns Hopkins Orthpaedic Surgery
🇺🇸
Baltimore, Maryland, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
University of Missouri
🇺🇸
Columbia, Missouri, United States
Mercy Clinic Springfield
🇺🇸
Ozark, Missouri, United States
Orlin & Cohen Orthopedics
🇺🇸
Garden City, New York, United States
University Orthopaedic Associates, LLC
🇺🇸
Somerset, New Jersey, United States
Anderson Clinic
🇺🇸
Alexandria, Virginia, United States
Rubin Institute for Advanced Orthopedics
🇺🇸
Baltimore, Maryland, United States
University of Florida
🇺🇸
Gainesville, Florida, United States