Primary Knee ArthroplastyNCT03153449
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
A study testing ATTUNE Revision Knee System in Total Knee Arthroplasty in people with Primary Knee Arthroplasty, run by DePuy Orthopaedics at 34 sites in 10 countries.
Trial summary
Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Primary Knee Arthroplasty
- What is being tested?
- ATTUNE Revision Knee System in Total Knee Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 34 sitesin 10 countries
- Study dates
- 19 Sep 2017to 17 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
- The decision to have knee replacement with the study device is regardless of the research.
- The devices are to be used according to the approved indications.
- 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.
- Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)
Who cannot join
- The Subject is a woman who is pregnant or lactating.
- Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study.
- Subject had a contralateral amputation.
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.
- Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
Show all 13Show fewer
- 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 5 years) or has a psychological disorder that could affect his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
- Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
- Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
- Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).
- -
Trial locations and contacts
34 sites in 10 countries.
34 sites in 10 countries
United States15 sites
Texas Institute for Hip & Knee Surgery
Austin, Texas, 78751
UNC Orthopaedics
Chapel Hill, North Carolina, 27514
OrthoCarolina Hip and Knee Center
Charlotte, North Carolina, 28207
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Florida Orthopedic Associates
DeLand, Florida, 32720
Colorado Joint Replacement
Denver, Colorado, 80210
Rothman Institute
Egg Harbor, New Jersey, 08234
Orthopaedic Center of the Rockies
Fort Collins, Colorado, 80525
Fondren Orthopedic Group
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Arthroplasty Foundation
Louisville, Kentucky, 40215
Southern Joint Replacement Institute
Nashville, Tennessee, 37203
Orthopedic Partners
Niantic, Connecticut, 06357
Scripps Clinic Torrey Pines
San Diego, California, 92037
United Kingdom7 sites
Hampshire Hospitals NHS Foundation Trust
Basingstoke
Victoria Hospital NHS Fife
Kirkcaldy
Chapel Allerton Orthopaedic Centre
Leeds
James Cook University Hospital
Middlesbrough
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry
Nuffield Orthopaedic Centre
Oxford
Wrightington Hospital
Wigan
Australia2 sites
Fremantle Hospital
Fremantle
St. John of God Murdoch Hospital
Perth
Canada2 sites
London Health Sciences Centre University Hospital
London, Ontario
Concordia Joint Replacement
Winnipeg
France2 sites
CHRU La Cavale Blanche
Brest
Centre Hospitalier Universitaire de Rennes
Rennes
Germany2 sites
Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche
Munich
Asklepios Orthopädische Klinik Lindenlohe
Schwandorf in Bayern
Austria1 site
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
Linz
About this study
Official title: Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty
Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.
Read the detailed description
Within primary TKA, there are factors that lead to more complex procedures that include patients with high BMIs, advanced preoperative deformities and ligamentous laxity. Such cases may require the surgeon to treat using ancillary components, such as stems and/or augments and/or additional constraint.
This post-market study will evaluate the short/medium term clinical performance and medium term survivorship of the ATTUNE Revision system system, which includes instrumentation, in complex primary TKA. The study is designed as a worldwide non-comparative, multi-center study with each site initially having a cohort of approximately 20 Subjects to recruit. The study will enroll approximately 200 fixed bearing and approximately 200 rotating platform configurations.
The 2-year KOOS-ADL (activities of daily living) was selected as the primary endpoint because it will evaluate the post-operative period during which outcomes typically plateau and will therefore provide a good indication of longer term outcomes
Male and female Subjects, age 22-80 years, inclusive, who require a primary knee arthroplasty in a joint that, due to deformity, instability, bone loss etc., necessitates the use of implants found within the ATTUNE Revision knee system and are suitable candidates for TKA using the ATTUNE® Revision system are eligible for enrollment in this study.
- Conditions
- Primary Knee Arthroplasty
- Being tested
- ATTUNE Revision Knee System in Total Knee Arthroplasty
- Keywords
- complex primary, deformity, ligamentous laxity
- Medical subject headings
- Congenital Abnormalities, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTUNE Revision Knee System in Total Knee ArthroplastyDevice
Also called complex primary knee arthroplasty
Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their anatomy is such that the use of revision components are required to perform primary total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| ATTUNE Revision knee system | Other | The ATTUNE Revision knees system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in complex primary knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets Receives: Device: ATTUNE Revision Knee System in Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS ADL
Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB and RP configurations.
Measured: 2 Years
Secondary outcomes (15)
Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL)
Evaluate change from preoperative baseline to the 5 yr timepoint in functional outcomes as measured using KOOS patient reported outcomes measure (PROM).
Measured: Baseline, 5 Year
Patient's Knee Implant Performance (PKIP)
Evaluate change from preoperative baseline to 5 yr timepoint in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure
Measured: Baseline, 5 Year
American Knee Society Score
valuate change from preoperative baseline to 5 yr timepoint in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure
Measured: Baseline, 5 Year
EQ-5D-5L
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes and quality of life assessments, as measured using the EQ-5D-5L patient reported outcome measure
Measured: Baseline, 5 year
VAS Pain Score
Evaluate change from preoperative baseline to 5 yr timepoint in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).
Measured: Baseline, 5 year
American Knee Society Score
Evaluate change from preoperative baseline to the 5 yr timepoint in patient reported satisfaction from the AKS 2011 over time as measured using a Likert scale.
Measured: Baseline, 5 year
American Knee Society Score (surgeon evaluation)
Estimate the change from preoperative baseline to the 5 yr timepoint in clinical outcomes using the 2011 AKS (surgeon evaluation)
Measured: Baseline, 5 year
Adverse Events
Evaluate type and frequency of Adverse Events
Measured: Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Readmissions
Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
Measured: 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Survivorship
Evaluate survivorship of the ATTUNE® Revision TKA system for the PS FB and PS RP configurations and the combined PS FB and PS RP configurations using Kaplan-Meier survival analysis at 1, 2, 3, 4 and 5 years.
Measured: 1, 2, 3, 4 and 5 years
Frequency of radiolucent line occurrence
Evaluate ATTUNE® Revision TKA fixation through zonal radiographic analysis of the bone-implant interface at 1, 2 and 5 years after surgery compared to the first postoperative radiographs.
Measured: 1, 2 and 5 years
Anatomic Tibiofemoral Alignment
Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Measured: 1, 2 and 5 years
Femoral component alignment
Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Measured: 1, 2 and 5 years
Tibial component alignment
Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Measured: 1, 2 and 5 years
Restoration of joint line
Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.
Measured: First post-operative radiograph (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start19 Sep 2017
- Primary completion17 Apr 2028 (estimated)
- Study completion17 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Knee ArthroplastyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grant Jamgochian, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153449
- Sponsor's protocol ID
- DSJ-2016-03
- Status last verified
- Sep 2026
- First submitted
- 7 May 2017
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03153449
- Acronym / sponsor ID
- DSJ-2016-03
- Conditions
- Primary Knee Arthroplasty
- Keywords
- complex primary, deformity, ligamentous laxity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 17 Apr 2028 (estimated)
- Study completion
- 17 Oct 2030 (estimated)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.
Detailed description
Within primary TKA, there are factors that lead to more complex procedures that include patients with high BMIs, advanced preoperative deformities and ligamentous laxity. Such cases may require the surgeon to treat using ancillary components, such as stems and/or augments and/or additional constraint.
This post-market study will evaluate the short/medium term clinical performance and medium term survivorship of the ATTUNE Revision system system, which includes instrumentation, in complex primary TKA. The study is designed as a worldwide non-comparative, multi-center study with each site initially having a cohort of approximately 20 Subjects to recruit. The study will enroll approximately 200 fixed bearing and approximately 200 rotating platform configurations.
The 2-year KOOS-ADL (activities of daily living) was selected as the primary endpoint because it will evaluate the post-operative period during which outcomes typically plateau and will therefore provide a good indication of longer term outcomes
Male and female Subjects, age 22-80 years, inclusive, who require a primary knee arthroplasty in a joint that, due to deformity, instability, bone loss etc., necessitates the use of implants found within the ATTUNE Revision knee system and are suitable candidates for TKA using the ATTUNE® Revision system are eligible for enrollment in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATTUNE Revision knee system | Other | Device: ATTUNE Revision Knee System in Total Knee ArthroplastyThe ATTUNE Revision knees system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in complex primary knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
- The decision to have knee replacement with the study device is regardless of the research.
- The devices are to be used according to the approved indications.
- 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.
Key exclusion criteria (13 listed)
- The Subject is a woman who is pregnant or lactating.
- Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study.
- Subject had a contralateral amputation.
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.
- Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
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 Revision Knee System in Total Knee ArthroplastyAlso: complex primary knee arthroplastyImplants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their anatomy is such that the use of revision components are required to perform primary total knee arthroplasty | Device | ATTUNE Revision knee system |
Primary outcome
KOOS ADL
Time frame: 2 Years
Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB and RP configurations.
15 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL)
Time frame: Baseline, 5 Year
Patient's Knee Implant Performance (PKIP)
Time frame: Baseline, 5 Year
American Knee Society Score
Time frame: Baseline, 5 Year
EQ-5D-5L
Time frame: Baseline, 5 year
VAS Pain Score
Time frame: Baseline, 5 year
American Knee Society Score
Time frame: Baseline, 5 year
American Knee Society Score (surgeon evaluation)
Time frame: Baseline, 5 year
Adverse Events
Time frame: Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Readmissions
Time frame: 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Survivorship
Time frame: 1, 2, 3, 4 and 5 years
Frequency of radiolucent line occurrence
Time frame: 1, 2 and 5 years
Anatomic Tibiofemoral Alignment
Time frame: 1, 2 and 5 years
Femoral component alignment
Time frame: 1, 2 and 5 years
Tibial component alignment
Time frame: 1, 2 and 5 years
Restoration of joint line
Time frame: First post-operative radiograph (1 day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Knee Arthroplasty
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Osteoarthritis of Knee, Recovery Following Primary Total Knee Arthroplasty
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Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty
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A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)
Inflammatory Arthritis, Primary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis)
Active, not recruiting
Journey Bicruciate Stabilized (BCS) Design and Legion Posterior Stabilized (PS) Design; Comparative Study
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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.
Grant Jamgochian study director
Sponsor GmbH
34 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATTUNE Revision Knee System in Total Knee Arthroplasty in people with Primary Knee Arthroplasty, run by DePuy Orthopaedics at 34 sites in 10 countries.
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 8 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, United Kingdom, Australia, Canada, France and 5 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
KOOS ADL (time frame: 2 Years). 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 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.