Osteoarthritis of the KneeNCT04630262
ATTUNE Cementless FB Tibial Base Clinical Study
A study testing ATTUNE Cementless CR Fixed Bearing and ATTUNE Cementless PS Fixed Bearing in people with Osteoarthritis of the Knee, run by DePuy Orthopaedics at 15 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- ATTUNE Cementless CR Fixed Bearing and ATTUNE Cementless PS Fixed Bearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 15 sitesUnited States
- Study dates
- 9 May 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- Subject has participated in a clinical study with an investigational product (drug or device) in the last two (2) years.
- 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.
- Subject is suffering from inflammatory arthritis in any joint (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
- 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).
- Severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
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- 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.
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Anderson Clinic
Alexandria, Virginia, 22306
Johns Hopkins Orthpaedic Surgery
Baltimore, Maryland, 21044
Towson Orthopaedic Associates
Baltimore, Maryland, 21204
Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, 21215
Coastal Orthopedics
Bradenton, Florida, 34209
American Hip Institute & Orthopedic Specialists
Chicago, Illinois, 60018
University of Missouri
Columbia, Missouri, 65212
Florida Orthopaedic Associates
DeLand, Florida, 32720
University of Florida
Gainesville, Florida, 32611
Orlin & Cohen Orthopedics
Garden City, New York, 11530
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525
Orthopaedic Specialty Institute
Irvine, California, 92618
Loyola University Medical Center
Maywood, Illinois, 60153
Mercy Clinic Springfield
Ozark, Missouri, 65721
University Orthopaedic Associates, LLC
Somerset, New Jersey, 08873
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ATTUNE Cementless CR Fixed Bearing, ATTUNE Cementless PS Fixed Bearing
- Keywords
- Osteoarthritis, Post-traumatic arthritis, Failed total knee, Knee, Total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTUNE Cementless CR Fixed BearingDevice
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and CR or (Medial Stabilized) MS Tibial Insert.
ATTUNE Cementless PS Fixed BearingDevice
Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and PS Tibial Insert.
| Study group | Role | What they receive |
|---|---|---|
| ATTUNE Cementless CR Fixed Bearing | Active comparator | Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Cruciate Retaining Configuration. Receives: Device: ATTUNE Cementless CR Fixed Bearing |
| ATTUNE Cementless PS Fixed Bearing | Active comparator | Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Posterior Stabilizing Configuration. Receives: Device: ATTUNE Cementless PS Fixed Bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, up to 10 months
Secondary outcomes (32)
Measure of Knees With Adverse Events
This measure will assess the percentage of knees with reported AEs throughout the duration of the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start9 May 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Why it stopped: Study was unfunded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- ATTUNE Cementless Fixed Bearing
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allyson Morris, Study director, DePuy Synthes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630262
- Sponsor's protocol ID
- DSJ_2019_05
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2020
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Clinical Investigation of the ATTUNE® Cementless Fixed Bearing Tibial Base and Cementless Patella Implants in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04630262
- Acronym / sponsor ID
- DSJ_2019_05
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Post-traumatic arthritis, Failed total knee, Knee, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was unfunded.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ATTUNE Cementless Fixed Bearing
| Arm | Type | Receives |
|---|---|---|
| ATTUNE Cementless CR Fixed Bearing | Active comparator | Device: ATTUNE Cementless CR Fixed BearingSubjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Cruciate Retaining Configuration. |
| ATTUNE Cementless PS Fixed Bearing | Active comparator | Device: ATTUNE Cementless PS Fixed BearingSubjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Posterior Stabilizing Configuration. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATTUNE Cementless CR Fixed BearingSubjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and CR or (Medial Stabilized) MS Tibial Insert. | Device | ATTUNE Cementless CR Fixed Bearing |
| ATTUNE Cementless PS Fixed BearingSubjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and PS Tibial Insert. | Device | ATTUNE Cementless PS Fixed Bearing |
Primary outcome
One Year Functional Responder Rate of First 225 Subjects
Time frame: 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
32 secondary outcomes
Measure of Knees With Adverse Events
Time frame: Through study completion, up to 10 months
Mean Number of Adverse Events Per Knee for Knees With Reported AEs
Time frame: Through study completion, up to 10 months
Measure of Knees With Device Deficiencies
Time frame: Through study completion, up to 10 months
Mean Number of Device Deficiencies Per Knee
Time frame: Through study completion, up to 10 months
One Year Functional Responder Rate All Subjects
Time frame: Through study completion, up to 10 months.
One Year Kaplan-Meier Implant Survivorship
Time frame: Through study completion, up to 10 months
Two Year Kaplan-Meier Implant Survivorship
Time frame: Through study completion, up to 10 months
Five Year Kaplan-Meier Implant Survivorship
Time frame: Through study completion, up to 10 months
6 Week Knee Society Score
Time frame: Through study completion, up to 6 weeks
6 Month Knee Society Score
Time frame: Through study completion, up to 6 Months
One Year Knee Society Score
Time frame: Through study completion, up to 10 months
Two Year Knee Society Score
Time frame: Through study completion, up to 10 months
Five Year Knee Society Score
Time frame: Through study completion, up to 10 months
Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Through study completion, up to 6 weeks
Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Through study completion, up to 6 Months
One Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Through study completion, up to 10 months
Two Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Through study completion, up to 10 months
Five Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Through study completion, up to 10 months
Six Week Forgotten Joint Score (FJS-12)
Time frame: Through study completion, up to 6 weeks
Six Month Forgotten Joint Score (FJS-12)
Time frame: Through study completion, up to 6 months
1 Year Forgotten Joint Score (FJS-12)
Time frame: Through study completion, up to 10 months
Two Year Forgotten Joint Score (FJS-12)
Time frame: Through study completion, up to 10 months
Five Year Forgotten Joint Score (FJS-12)
Time frame: Through study completion, up to 10 months
Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Through study completion, up to 6 weeks
Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Through study completion, up to 6 months
One Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Through study completion, up to 10 months
Two Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Through study completion, up to 10 months
Five Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Through study completion, up to 10 months
Six Month Investigator-conducted Radiographic Analysis
Time frame: Through study completion, up to 6 Months
One Year Investigator-conducted Radiographic Analysis
Time frame: Through study completion, up to 10 months
Two Year Investigator-conducted Radiographic Analysis
Time frame: Through study completion, up to 10 months
Five Year Investigator-conducted Radiographic Analysis
Time frame: Through study completion, up to 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allyson Morris study director
DePuy Synthes
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATTUNE Cementless CR Fixed Bearing and ATTUNE Cementless PS Fixed Bearing in people with Osteoarthritis of the Knee, run by DePuy Orthopaedics at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One Year Functional Responder Rate of First 225 Subjects (time frame: through study completion, up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025; AzTrials last refreshed its copy on 27 Oct 2026.