Arthroplasty, Replacement, KneeANTHEM PSNCT03078543
Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System
An observational study of Arthroplasty, Replacement, Knee, run by Smith & Nephew, Inc. at 8 sites in 5 countries.
Trial summary
The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- ANTHEM™ PS Total Knee System implant
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 28 Jun 2017to 30 Apr 2029
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing primary total knee arthroplasty.
Who may be able to join
- Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease
- Subject is willing to sign and date an EC-approved consent form
- Subject is male or female between the ages of 18 and 75 years of age
- Subject plans to be available through ten (10) years post-operative follow-up
- Subject agrees to follow the study protocol
Who cannot join
- Subject would receive the ANTHEM™ Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
- Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
- Subject has a history of patellar fracture, patellectomy, patello-femoral instability
- Subject has inflammatory arthritis
- Subject possesses a contralateral or ipsilateral revision hip arthroplasty
- Subject has ipsilateral hip arthritis resulting in flexion contracture
Show all 19Show fewer
- Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:
- Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
- Contralateral primary total knee or unicondylar knee arthroplasty
- Subject has an active infection or sepsis (treated or untreated)
- Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated
- Subject has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes mellitus i.e. not under treatment with oral/injectable medications to control blood glucose levels, fibromyalgia, moderate to severe renal insufficiency or neuromuscular disease)
- Subject has a chronic, contralateral lower extremity condition causing abnormal ambulation, which is not related to the knee (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
- Subject is pregnant or plans to become pregnant during the study
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse
- Subject has a BMI>40
- Subject is enrolled in another investigational drug, biologic, or device study
- Subject is facing current or impending incarceration
- Subject has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
South Korea3 sites
Chonnam National University Hwasun Hospital
Hwasan
Severance Hospital, Yonsei University Health System
Seoul
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam, 626-770
Italy2 sites
Instituto Clinico Sant'Ambrogio
Milan, Milan, 20149
Fatebenefratelli Isola Tiberina Gemelli Hospital - Isle of Rome
Roma, 00186
China1 site
Beijing Jishuitan Hospital, Institute of Orthopedics & Traumatology,
Beijing, Beijing Municipality, 100035
About this study
Official title: A Prospective, Multicentre, Cohort Study Assessing the Safety and Efficacy of the ANTHEM™ PS Total Knee System in Patients Following a Total Knee Arthroplasty
The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
Read the detailed description
The ANTHEM PS Study is a prospective, multicentre, cohort study to collect relevant patient reported, clinical, surgical and radiological data from 143 subjects implanted with the ANTHEM™PS Knee System for degenerative joint disease in up to 6 clinical sites globally. Total study duration for study participants will be 10 years with post-operative follow-up visits planned for 6 weeks, 1 year, 2 years, 5 years, 7.5 years and 10 years. The study will evaluate the 10 year implant survivorship and the safety and outcome of the ANTHEM™PS Knee System over 10 years. This is a post-market study of the ANTHEM™PS Total Knee System.
The primary objective of the study is to demonstrate non-inferiority (8% margin) of 10 year implant survivorship of the ANTHEM™PS Total Knee System in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature.
The secondary objectives of the study are to evaluate shorter and long term safety and outcomes of the ANTHEM™ PS Total Knee System.
- Knee injury and Osteoarthritis Outcomes Score (KOOS)
- 2011 Knee Society Score (2011 KSS)
- EQ-5D - 3L
- Femoral Fit ('Perfect Fit' rate)
- Radiographic Assessment
- Revision for any reason
- Adverse Events (AEs)
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- ANTHEM™ PS Total Knee System implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTHEM™ PS Total Knee System implantDevice
The ANTHEM™ PS Total Knee System is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties. The ANTHEM™ PS Total Knee System consists of the following components:
- Cobalt-Chrome (Co-Cr) femoral components - Posterior stabilised
- Titanium primary tibial components
- Posterior-stabilised ultra-high molecular weight polyethylene (UHMWPE)
- Polyethylene patella components The resulting product is sufficient to accommodate a wide range of clinical applications.
| Study group | Role | What they receive |
|---|---|---|
| ANTHEM™ PS Total Knee System implant | The ANTHEM™ PS Total Knee System will demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature Receives: Device: ANTHEM™ PS Total Knee System implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ten year Anthem knee implant survivorship
The ANTHEM™ Total Knee System will demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
Measured: Study participants will be followed for 10 years
Secondary outcomes (7)
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Participant Questionnaire to assess the patients opinion about their knee and associated problems.
Measured: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years
2011 Knee Society Score (2011 KSS)
Participant questionnaire including a pre-operative section supplying information relating to the current symptoms, knee function, satisfaction with their pre-operative functional activities, and the expectations they have of the results of the total knee arthroplasty. The surgeon then completes information on objective measures such as joint alignment, instability, motions and symptoms.
Measured: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years
EQ-5D-3L
Participant Questionnaire_ The EQ-5D-3L questionnaire is a self-rating evaluation questionnaire made up of health status measurements of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participants also evaluate their overall health status using a visual analogue scale.
Measured: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5, 7.5 and 10 years
Femoral Fit ('Perfect Fit' rate)
For each individual knee, 'overall femoral component fit' across the combined three femur levels; condylar, junctional and trochlear will be characterised under three classifications:
- Perfect Fit: just fit at all three levels or just fit at two levels and underhang at one
- Overhang: overhang observed on at least one of the three levels
- Underhang: underhang at all three levels or underhang at two and just fit at one
Measured: Femoral Fit will be measured at surgery, assessed for an estimated 1 hour
Radiographic Assessments to adequately assess the component position, prosthesis-bone interface, and the knee alignment.
The Knee X Rays taken during the course of the study will include Full leg weight-bearing, bilateral anteroposterior (AP), lateral and patellar radiographs. The knee assessments to be made from radiographs will include: Radiographic findings; Component orientation; Radiolucencies; Migration; Osteolysis and Stress shielding.
Measured: Radiographic assessments to be conducted at Pre-operation timepoint (Baseline), post-operative (Day 1), 6 weeks, 1,2, 5, and 10 years
Revision for any reason
Anthem implant revision done for any reason
Measured: Anytime during the 10 year study period
Adverse Events
All adverse events captured during the entire study period to provide patient safety oversight
Measured: Adverse events are collected at any time during the study with formal timepoints being at surgery, 6 weeks, 1,2, 5, 7.5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start28 Jun 2017
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julian Yang, Study director, Smith & Nephew Medical (Shanghai) Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078543
- Sponsor's protocol ID
- 14-4065-09
- Other IDs
- OREM-ANTHEM-PMCFU
- Acronym
- ANTHEM PS
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2017
- Last updated
- 11 Mar 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Cohort Study Assessing the Safety and Efficacy of the ANTHEM™ PS Total Knee System in Patients Following a Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03078543
- Acronym / sponsor ID
- ANTHEM PS / 14-4065-09
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 13 Mar 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.
The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
Detailed description
The ANTHEM PS Study is a prospective, multicentre, cohort study to collect relevant patient reported, clinical, surgical and radiological data from 143 subjects implanted with the ANTHEM™PS Knee System for degenerative joint disease in up to 6 clinical sites globally. Total study duration for study participants will be 10 years with post-operative follow-up visits planned for 6 weeks, 1 year, 2 years, 5 years, 7.5 years and 10 years. The study will evaluate the 10 year implant survivorship and the safety and outcome of the ANTHEM™PS Knee System over 10 years. This is a post-market study of the ANTHEM™PS Total Knee System.
The primary objective of the study is to demonstrate non-inferiority (8% margin) of 10 year implant survivorship of the ANTHEM™PS Total Knee System in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature.
The secondary objectives of the study are to evaluate shorter and long term safety and outcomes of the ANTHEM™ PS Total Knee System.
- Knee injury and Osteoarthritis Outcomes Score (KOOS)
- 2011 Knee Society Score (2011 KSS)
- EQ-5D - 3L
- Femoral Fit ('Perfect Fit' rate)
- Radiographic Assessment
- Revision for any reason
- Adverse Events (AEs)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANTHEM™ PS Total Knee System implant | – | Device: ANTHEM™ PS Total Knee System implantThe ANTHEM™ PS Total Knee System will demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing primary total knee arthroplasty.
Key inclusion criteria (5 listed)
- Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease
- Subject is willing to sign and date an EC-approved consent form
- Subject is male or female between the ages of 18 and 75 years of age
- Subject plans to be available through ten (10) years post-operative follow-up
- Subject agrees to follow the study protocol
Key exclusion criteria (19 listed)
- Subject would receive the ANTHEM™ Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
- Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
- Subject has a history of patellar fracture, patellectomy, patello-femoral instability
- Subject has inflammatory arthritis
- Subject possesses a contralateral or ipsilateral revision hip arthroplasty
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 |
|---|---|---|
| ANTHEM™ PS Total Knee System implantThe ANTHEM™ PS Total Knee System is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties. The ANTHEM™ PS Total Knee System consists of the following components: * Cobalt-Chrome (Co-Cr) femoral components - Posterior stabilised * Titanium primary tibial components * Posterior-stabilised ultra-high molecular weight polyethylene (UHMWPE) * Polyethylene patella components The resulting product is sufficient to accommodate a wide range of clinical applications. | Device | ANTHEM™ PS Total Knee System implant |
Primary outcome
Ten year Anthem knee implant survivorship
Time frame: Study participants will be followed for 10 years
The ANTHEM™ Total Knee System will demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
7 secondary outcomes
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Time frame: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years
2011 Knee Society Score (2011 KSS)
Time frame: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years
EQ-5D-3L
Time frame: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5, 7.5 and 10 years
Femoral Fit ('Perfect Fit' rate)
Time frame: Femoral Fit will be measured at surgery, assessed for an estimated 1 hour
Radiographic Assessments to adequately assess the component position, prosthesis-bone interface, and the knee alignment.
Time frame: Radiographic assessments to be conducted at Pre-operation timepoint (Baseline), post-operative (Day 1), 6 weeks, 1,2, 5, and 10 years
Revision for any reason
Time frame: Anytime during the 10 year study period
Adverse Events
Time frame: Adverse events are collected at any time during the study with formal timepoints being at surgery, 6 weeks, 1,2, 5, 7.5 and 10 years
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 11 Mar 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.
Julian Yang study director
Smith & Nephew Medical (Shanghai) Limited
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Knee, run by Smith & Nephew, Inc. at 8 sites in 5 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 5 inclusion and 19 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea, Italy, China, South Africa, Thailand. 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?
Ten year Anthem knee implant survivorship (time frame: Study participants will be followed for 10 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 11 Mar 2026.