Safety and Efficacy of the ANTHEM™ CR Total Knee System (Anthem CR)

March 9, 2026 updated by: Smith & Nephew Pte Ltd

A Prospective, Multicentre, Cohort Study Assessing the Safety and Efficacy of the ANTHEM™ CR Total Knee System in Patients Following a Total Knee Arthroplasty

This clinical study will evaluate the short-term (1- and 2-year) and medium term (5-year) safety and performance of the ANTHEM™ CR Total Knee System in patients with non-inflammatory degenerative joint disease of the knee requiring total knee replacement. Clinical, radiographic, Health Economic Outcomes and safety outcomes will be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To assess the safety and performance of the ANTHEM™ CR Total Knee System in patients with degeneration of the knee by demonstrating non-inferiority in the revision-free survival rate at 5 years compared to a literature reference rate of 96.6% (Australian Orthopaedic Association annual report 2016).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Parekhs Hospital
    • Haryana
      • Hisar, Haryana, India, 125001
        • Aadhar Health Institute
    • Punjab
      • Mohali, Punjab, India, 160071
        • Ivy Hospital - Ivy Elite Institute of Orthopaedics
  • Italy
      • Milan, Italy, 20148
        • Istituto Clinico San Siro
    • Milan
      • Milan, Milan, Italy, 20149
        • Instituto Clinico Sant'Ambrogio
  • South Africa
    • Durban
      • Westville, Durban, South Africa, 3630
        • Westville Hospital
  • South Korea
    • Jeonranam-do
      • Hwasun, Jeonranam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
    • Korea
      • Incheon, Korea, South Korea, 21565
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A minimum of 153 subjects undergoing total knee arthroplasty for degenerative joint disease will be implanted with ANTHEM™ CR Total Knee System.

Description

Inclusion Criteria:

  1. Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease.
  2. Subject is willing to sign and date an EC-approved consent form.
  3. Subject has posterior cruciate ligament and all collateral ligaments intact in the index joint.
  4. Subject is 18 to 75 years old at time of inclusion.
  5. Subject plans to be available through ten (10) years postoperative follow-up.
  6. Subject agrees to follow the study protocol.
  7. Subject has achieved skeletal maturity as deemed by enrolling investigator.

Exclusion Criteria:

  1. Subject would receive the ANTHEM™ CR Total Knee System on the affected knee as a revision for a previously failed (TKA) or unicondylar knee arthroplasty (UKA).
  2. Subject received TKA on the contralateral knee as a revision for a previously failed TKA or UKA.
  3. Subject has a history of patellar fracture, patellectomy, or patello-femoral Instability.
  4. Subject has inflammatory arthritis.
  5. Subject possesses a contralateral or ipsilateral revision hip arthroplasty.
  6. Subject has ipsilateral hip arthritis resulting in flexion contracture.

  7. 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 TKA or UKA.
  8. Inadequate bone stock which would make the procedure unjustifiable including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia as deemed by the enrolling investigator.
  9. Subject has collateral ligament insufficiency.
  10. Subject has an active infection or sepsis (treated or untreated) or previous intra-articular infections.
  11. Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated.
  12. 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).
  13. Subject has contralateral lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
  14. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
  15. 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.
  16. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
  17. Any subject that meets the definition of a Vulnerable Subject per ISO14155:2011: individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Non-Inferiority 10 years postoperatively
Time Frame: 10 years postoperatively
Non-inferiority of 10-year implant survivorship of the ANTHEM™ CR Total Knee System in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature.
10 years postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in implant fixation measured by radiographic assessment
Time Frame: 6 weeks, 1 year, 2 years, and 5 years
based on comparison of antero posterior and lateral radiographs
6 weeks, 1 year, 2 years, and 5 years
Change in bone integrity measured by radiographic assessment
Time Frame: 6 weeks, 1 year, 2 years, and 5 years
based on comparison of antero-posterior and lateral radiographs
6 weeks, 1 year, 2 years, and 5 years
Number of Adverse Events
Time Frame: 6 weeks, 1 year, 2 years, and 5 years
Number and frequency of all types adverse events
6 weeks, 1 year, 2 years, and 5 years
Quality of life measured by EQ-5D-3L
Time Frame: 6 weeks, 1 year, 2 years, and 5 years
The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses.
6 weeks, 1 year, 2 years, and 5 years
Pain as measured by Knee Society Score (2011 KSS)
Time Frame: 6 weeks, 1 year, 2 years, and 5 years
This validated tool that combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms.
6 weeks, 1 year, 2 years, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smith & Nephew Pte Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jae Ang Sim, M.D., Gachon University Gil Medical
  • Principal Investigator: Manuj Wadhwa, M.D., Ivy Hospital - Ivy Elite Institute of Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2034

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-4065-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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