ATTUNE Cementless FB Tibial Base Clinical Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Device: ATTUNE Cementless CR Fixed Bearing; Device: ATTUNE Cementless PS Fixed Bearing

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Orthopaedic Specialty Institute
  • Florida
    • Bradenton, Florida, United States, 34209
      • Coastal Orthopedics
    • DeLand, Florida, United States, 32720
      • Florida Orthopaedic Associates
    • Gainesville, Florida, United States, 32611
      • University of Florida
  • Illinois
    • Chicago, Illinois, United States, 60018
      • American Hip Institute & Orthopedic Specialists
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Rubin Institute for Advanced Orthopedics
    • Baltimore, Maryland, United States, 21204
      • Towson Orthopaedic Associates
    • Baltimore, Maryland, United States, 21044
      • Johns Hopkins Orthpaedic Surgery
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Orthopaedic Associates of Michigan
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri
    • Ozark, Missouri, United States, 65721
      • Mercy Clinic Springfield
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • University Orthopaedic Associates, LLC
  • New York
    • Garden City, New York, United States, 11530
      • Orlin & Cohen Orthopedics
  • Virginia
    • Alexandria, Virginia, United States, 22306
      • Anderson Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Knees With Adverse Events	This measure will assess the percentage of knees with reported AEs throughout the duration of the study.	Through study completion, up to 10 months
Mean Number of Adverse Events Per Knee for Knees With Reported AEs	This measure will assess the mean number of AEs per Knee for those knees with reported AEs throughout the duration of the study.	Through study completion, up to 10 months
Measure of Knees With Device Deficiencies	This measure will assess count of knees with various types of device deficiencies reported throughout the duration of the study.	Through study completion, up to 10 months
Mean Number of Device Deficiencies Per Knee	This measure will assess the mean number of device deficiencies (DD) per knee reported throughout the duration of the study.	Through study completion, up to 10 months
One Year Functional Responder Rate All Subjects	Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for all subjects.	Through study completion, up to 10 months.
One Year Kaplan-Meier Implant Survivorship	Number/rate of subjects with all implants remaining implanted at the 1 year timepoint.	Through study completion, up to 10 months
Two Year Kaplan-Meier Implant Survivorship	Number/rate of subjects with all implants remaining implanted at the 2- year timepoint.	Through study completion, up to 10 months
Five Year Kaplan-Meier Implant Survivorship	Number/rate of subjects with all implants remaining implanted at the 5- year timepoint.	Through study completion, up to 10 months
6 Week Knee Society Score	Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.	Through study completion, up to 6 weeks
6 Month Knee Society Score	Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations.	Through study completion, up to 6 Months
One Year Knee Society Score	Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.	Through study completion, up to 10 months
Two Year Knee Society Score	Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.	Through study completion, up to 10 months
Five Year Knee Society Score	Mixed outcome measure that derives a score using physician input and patient input including current symptoms, knee function, patient satisfaction and expectations. The higher the score, the better the function, satisfaction, and expectations.	Through study completion, up to 10 months
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)	A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.	Through study completion, up to 6 weeks
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)	A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.	Through study completion, up to 6 Months
One Year Knee Injury and Osteoarthritis Outcome Score (KOOS)	A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.	Through study completion, up to 10 months
Two Year Knee Injury and Osteoarthritis Outcome Score (KOOS)	A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.	Through study completion, up to 10 months
Five Year Knee Injury and Osteoarthritis Outcome Score (KOOS)	A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The scores for each dimension are calculated by summing the answers to the questions. The resulting scores are then transferred to a scale from 0 to 100 with 0 representing extreme knee problems and 100 representing no problems.	Through study completion, up to 10 months
Six Week Forgotten Joint Score (FJS-12)	The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is	Through study completion, up to 6 weeks
Six Month Forgotten Joint Score (FJS-12)	The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is	Through study completion, up to 6 months
1 Year Forgotten Joint Score (FJS-12)	The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is	Through study completion, up to 10 months
Two Year Forgotten Joint Score (FJS-12)	The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is	Through study completion, up to 10 months
Five Year Forgotten Joint Score (FJS-12)	The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is	Through study completion, up to 10 months
Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L)	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.	Through study completion, up to 6 weeks
Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L)	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.	Through study completion, up to 6 months
One Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.	Through study completion, up to 10 months
Two Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.	Through study completion, up to 10 months
Five Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.	Through study completion, up to 10 months
Six Month Investigator-conducted Radiographic Analysis	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.	Through study completion, up to 6 Months
One Year Investigator-conducted Radiographic Analysis	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.	Through study completion, up to 10 months
Two Year Investigator-conducted Radiographic Analysis	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.	Through study completion, up to 10 months
Five Year Investigator-conducted Radiographic Analysis	Rate of radiolucencies and other significant radiographic findings identified by clinical investigators.	Through study completion, up to 10 months

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Study Director: Allyson Morris, DePuy Synthes

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Total knee arthroplasty; Post-traumatic arthritis; Failed total knee
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: DSJ_2019_05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Time Frame: Study Protocol will be immediately available.
• IPD Sharing Access Criteria: There are no additional qualifying criteria for access to the study protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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