Revision Total Knee ArthroplastyNCT03153475
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
A study testing ATTUNE Revision Knee System in Revision Total Knee Arthroplasty in people with Revision Total Knee Arthroplasty, run by DePuy Orthopaedics at 38 sites in 13 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 revision total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Revision Total Knee Arthroplasty
- What is being tested?
- ATTUNE Revision Knee System in Revision 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
- 38 sitesin 13 countries
- Study dates
- 30 May 2017to 31 Mar 2029
- 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.
- Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or prior revision TKA that requires a revision procedure of implanted tibial and/or femoral components.
- The decision to perform a knee revision with the study device is regardless of the research.
- 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
- The devices are to be used according to the approved indications.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
- The Subject is a woman who is pregnant or lactating.
- Contralateral knee has already been enrolled in this study.
- Subject had a contralateral amputation.
- Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive RTKA.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
Show all 11Show fewer
- 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.
- Uncontrolled gout
Trial locations and contacts
38 sites in 13 countries.
38 sites in 13 countries
United States16 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
Mery Hospital
Ozark, Missouri, 65721
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
North Yorks
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry
Nuffield Orthopaedic Centre
Oxford
Wrightington Hospital
Wigan
Australia2 sites
The Gold Coast Centre for Bone and Joint Surgery
Gold Coast
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
Switzerland1 site
Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology
Basel
About this study
Official title: Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision 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 revision total knee arthroplasty.
Read the detailed description
The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship.
The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed.
Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.
- Conditions
- Revision Total Knee Arthroplasty
- Being tested
- ATTUNE Revision Knee System in Revision Total Knee Arthroplasty
- Keywords
- Revision knee surgery, implant replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTUNE Revision Knee System in Revision Total Knee ArthroplastyDevice
Also called previous unsuccessful knee replacement, knee revision
Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their existing implants need to be removed and replaced.
| Study group | Role | What they receive |
|---|---|---|
| ATTUNE Revision Knee System | Other | The ATTUNE Revision 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 revision knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets Receives: Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB and PS RP configurations.
Measured: 5 Years
Secondary outcomes (14)
Patient's Knee Implant Performance (PKIP)
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure (overalll and subscores)
Measured: Baseline, 2 and 5 yr timepoints
Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the KOOS-PS patient reported outcome measures
Measured: Baseline, 2 year and 5 Year
American Knee Society Score
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure
Measured: Baseline, 2 year, 5 year
EQ-5D-5L
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the EQ-5D-5L patient reported outcome measures
Measured: Baseline, 2 year and 5 year
VAS Pain Score
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).
Measured: Baseline, 2 year and 5 year
Patient Satisfaction
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.
Measured: Baseline, 2 year and 5 year
Adverse Events
Evaluate type and frequency of Adverse Events
Measured: Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.
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 yrs., 3 yrs., 4 yrs., 5 yrs
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, and 4 years.
Measured: 1, 2, 3 and 4 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 start30 May 2017
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Total 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
- Sukhjeet Kaur, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153475
- Sponsor's protocol ID
- DSJ-2016-02
- Status last verified
- Sep 2026
- First submitted
- 7 May 2017
- Last updated
- 28 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 28 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 Revision Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03153475
- Acronym / sponsor ID
- DSJ-2016-02
- Conditions
- Revision Total Knee Arthroplasty
- Keywords
- Revision knee surgery, implant replacement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 30 May 2017 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (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 revision total knee arthroplasty.
Detailed description
The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship.
The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed.
Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.
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 Revision Total Knee ArthroplastyThe ATTUNE Revision 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 revision 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 (6 listed)
- Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
- Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or prior revision TKA that requires a revision procedure of implanted tibial and/or femoral components.
- The decision to perform a knee revision with the study device is regardless of the research.
- 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 (11 listed)
- The Subject is a woman who is pregnant or lactating.
- Contralateral knee has already been enrolled in this study.
- Subject had a contralateral amputation.
- Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive RTKA.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
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 Revision Total Knee ArthroplastyAlso: previous unsuccessful knee replacement, knee revisionImplants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their existing implants need to be removed and replaced. | Device | ATTUNE Revision Knee System |
Primary outcome
Survivorship
Time frame: 5 Years
To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB and PS RP configurations.
14 secondary outcomes
Patient's Knee Implant Performance (PKIP)
Time frame: Baseline, 2 and 5 yr timepoints
Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)
Time frame: Baseline, 2 year and 5 Year
American Knee Society Score
Time frame: Baseline, 2 year, 5 year
EQ-5D-5L
Time frame: Baseline, 2 year and 5 year
VAS Pain Score
Time frame: Baseline, 2 year and 5 year
Patient Satisfaction
Time frame: Baseline, 2 year and 5 year
Adverse Events
Time frame: Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.
Readmissions
Time frame: 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs
Survivorship
Time frame: 1, 2, 3 and 4 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 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Revision Total Knee Arthroplasty
Active, not recruiting
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
Recruiting
Fiber Smoothie Supplement
Total Knee Arthroplasty Revision, Inflammatory Markers
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
RecruitingObservational study
Gut Microbiome in Orthopaedics: Revision Total Knee Arthroplasty
Revision Total Knee Arthroplasty, Osteoarthritis, Knee
Recruiting
Hinge vs CCK Implants
Revision Arthroplasty, Knee
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.
Sukhjeet Kaur study director
Sponsor GmbH
38 sites in 13 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 Revision Total Knee Arthroplasty in people with Revision Total Knee Arthroplasty, run by DePuy Orthopaedics at 38 sites in 13 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 6 inclusion and 11 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 28 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 38 sites in United States, United Kingdom, Australia, Canada, France and 8 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?
Survivorship (time frame: 5 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 28 Sep 2026.