OsteoarthritisNCT02839850
14022 ATTUNE Cementless RP Clinical Performance Evaluation
A study testing Cementless Total Knee Arthroplasty in people with Osteoarthritis, run by DePuy Orthopaedics at 20 sites in 9 countries.
Trial summary
The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Cementless Total Knee Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 1 Sep 2016to 1 Sep 2027
- 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 surgery, inclusive.
- Subject was diagnosed with NIDJD.
- Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
- 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 PROs 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.
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy 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 their 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 (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
- Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
- Subject has a medical condition with less than five (5) years life expectancy.
- Uncontrolled gout
Trial locations and contacts
20 sites in 9 countries.
20 sites in 9 countries
United States10 sites
SUNY downstate Medical Center
Brooklyn, New York, 11203
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Florida Research Associates
DeLand, Florida, 32720
Colorado Joint Replacement
Denver, Colorado, 80210
Rothman Institute
Egg Harbor, New Jersey, 08234
Associated Orthopaedics of Kingsport
Kingsport, Tennessee, 37660
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Texas Tech University Heath Science Center
Lubbock, Texas, 49416
New London Hospital
New London, New Hampshire, 03257
Hampton Roads Orthopaedics and Sports Medicine
Newport News, Virginia, 23606
France2 sites
CHU de la Cavale Blanche
Brest, Cedex, 29285
Sevice de Chirurgie Orthoedique et Traumatologique
Salouël, 80480
United Kingdom2 sites
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Wrightington Hospital
Wigan, Lancashire, WN6 9EP
Austria1 site
Krankenhaus der Barmherzigen Schwestern Ried im Innkreis
Ried im Innkreis, Upper Austria, 4910
Canada1 site
Foothills Medical Centre, University of Calgary
Calgary, Alberta, T2N 2T9
Germany1 site
Klinikum Garmisch-Partenkirchen GmbH
Garmisch-Partenkirchen, 82467
About this study
Official title: Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty
The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
Read the detailed description
The secondary objectives of this study are:
- Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L.
- Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr.
- Evaluate type and frequency of Adverse Events
- Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.
- Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
- Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
- Conditions
- Osteoarthritis
- Being tested
- Cementless Total Knee Arthroplasty
- Keywords
- Arthroplasty, replacement, Knee, function, radiographic, survivorship
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cementless Total Knee ArthroplastyDevice
Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)
| Study group | Role | What they receive |
|---|---|---|
| ATTUNE Cementless RP TKA | Experimental | Subjects will receive a cementless, rotating platform total knee arthroplasty Receives: Device: Cementless Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Minimum 2 years (670-1033 days after surgery)
Secondary outcomes (13)
Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.
Measured: Minimum 2 years (670-1033 days after surgery)
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Minimum 2 years (670-1033 days after surgery)
Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). The surgeon completes questions regarding objective knee indicators. Likert responses are used, typically with five response options.
Measured: Minimum 2 years (670-1033 days after surgery)
Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Measured: Minimum 2 years (670-1033 days after surgery)
Modified VAS Pain Score: Pain and Satisfaction
VAS Pain Score is a standardized instrument for use as a measure of pain and satisfaction that is designed for completion by the subject. This modified version has scores that are discrete numbers rather than a continual scale
Measured: Minimum 2 years (670-1033 days after surgery)
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.
Measured: Pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)
Survivorship
Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP)
Measured: Minimum 2 years (670-1033 days after surgery)
Survivorship
Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP)
Measured: Minimum 5 years (1764-2190 days after surgery)
Implant fixation: Radiographic assessment of bone-implant interface performance
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Measured: 6 weeks (1-90 days after surgery)
Implant fixation: Radiographic assessment of bone-implant interface performance
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Measured: 6 months (91-303 days after surgery)
Implant fixation: Radiographic assessment of bone-implant interface performance
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Measured: Minimum 1 year (304-669 days after surgery).
Implant fixation: Radiographic assessment of bone-implant interface performance
Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
Measured: Minimum 2 years (670-1033 days after surgery)
Evaluate changes in femoral component and tibial component alignment
Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.
Measured: Minimum 2 years (670-1033 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 540 participants (estimated)
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
- NCT02839850
- Sponsor's protocol ID
- 14022
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2016
- 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 Cementless Rotating Platform Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02839850
- Acronym / sponsor ID
- 14022
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, replacement, Knee, function, radiographic, survivorship
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- 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.
The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
Detailed description
The secondary objectives of this study are:
- Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L.
- Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr.
- Evaluate type and frequency of Adverse Events
- Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.
- Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
- Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATTUNE Cementless RP TKA | Experimental | Device: Cementless Total Knee ArthroplastySubjects will receive a cementless, rotating platform total knee arthroplasty |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
- Subject was diagnosed with NIDJD.
- Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
- 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 .
- Subject had a contralateral amputation.
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy 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 |
|---|---|---|
| Cementless Total Knee ArthroplastyPatients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP) | Device | ATTUNE Cementless RP TKA |
Primary outcome
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
Time frame: Minimum 2 years (670-1033 days after surgery)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
13 secondary outcomes
Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
Time frame: Minimum 2 years (670-1033 days after surgery)
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Minimum 2 years (670-1033 days after surgery)
Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
Time frame: Minimum 2 years (670-1033 days after surgery)
Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
Time frame: Minimum 2 years (670-1033 days after surgery)
Modified VAS Pain Score: Pain and Satisfaction
Time frame: Minimum 2 years (670-1033 days after surgery)
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
Time frame: Pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)
Survivorship
Time frame: Minimum 2 years (670-1033 days after surgery)
Survivorship
Time frame: Minimum 5 years (1764-2190 days after surgery)
Implant fixation: Radiographic assessment of bone-implant interface performance
Time frame: 6 weeks (1-90 days after surgery)
Implant fixation: Radiographic assessment of bone-implant interface performance
Time frame: 6 months (91-303 days after surgery)
Implant fixation: Radiographic assessment of bone-implant interface performance
Time frame: Minimum 1 year (304-669 days after surgery).
Implant fixation: Radiographic assessment of bone-implant interface performance
Time frame: Minimum 2 years (670-1033 days after surgery)
Evaluate changes in femoral component and tibial component alignment
Time frame: Minimum 2 years (670-1033 days after surgery)
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
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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.
Sukhjeet Kaur study director
Sponsor GmbH
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cementless Total Knee Arthroplasty in people with Osteoarthritis, run by DePuy Orthopaedics at 20 sites in 9 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 7 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 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 20 sites in United States, France, United Kingdom, Austria, Canada and 4 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?
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL) (time frame: Minimum 2 years (670-1033 days after surgery)). 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.