Safety and Efficacy of the ANTHEM™ CR Total Knee System (Anthem CR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03885622 |
Recruitment Status :
Recruiting
First Posted : March 21, 2019
Last Update Posted : January 6, 2020
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Condition or disease | Intervention/treatment |
---|---|
Non-inflammatory Degenerative Joint Disease | Device: ANTHEM™ CR Total Knee System |
Study Type : | Observational |
Estimated Enrollment : | 118 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | A Prospective, Multicentre, Cohort Study Assessing the Safety and Efficacy of the ANTHEM™ CR Total Knee System in Patients Following a Total Knee Arthroplasty |
Actual Study Start Date : | November 23, 2018 |
Estimated Primary Completion Date : | March 1, 2025 |
Estimated Study Completion Date : | March 1, 2025 |

- Device: ANTHEM™ CR Total Knee System
The ANTHEM CR Total Knee System is a CE marked device. It is a cruciate retaining (CR) total knee system. It is intended to be used in patients for primary total knee replacement surgery where the posterior cruciate ligament and collateral ligaments remain intact. It is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties.
- Implant survival 5 years postoperatively [ Time Frame: 5 years postoperatively ]
- 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
- 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
- Number of Adverse Events [ Time Frame: 6 weeks, 1 year, 2 years, and 5 years ]Number and frequency of all types adverse events
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 has posterior cruciate ligament and all collateral ligaments intact in the index joint.
- Subject is 18 to 75 years old at time of inclusion.
- Subject plans to be available through five (5) years postoperative follow-up.
- Subject agrees to follow the study protocol.
- Subject has achieved skeletal maturity as deemed by enrolling investigator.
Exclusion Criteria:
- 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).
- Subject received TKA on the contralateral knee as a revision for a previously failed TKA or UKA.
- Subject has a history of patellar fracture, patellectomy, or 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.
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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.
- 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.
- Subject has collateral ligament insufficiency.
- Subject has an active infection or sepsis (treated or untreated) or previous intra-articular infections.
- 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 contralateral lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
- Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
- 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.
- Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885622
Contact: Marie-Christine Mallaroni | +33 (0)6 77 64 03 41 | mariechristine.mallaroni@smith-nephew.com |
India | |
Parekhs Hospital | Terminated |
Ahmedabad, Gujarat, India, 380015 | |
Aadhar Health Institute | Recruiting |
Hisar, Haryana, India, 125001 | |
Contact: Amit Yadav amity1516@gmail.com | |
Contact: Ravi Jaglan +91 09896650539 rveejaglan@gmail.com | |
Principal Investigator: Vikram Jain | |
Sub-Investigator: Sartaj Gil | |
Ivy Hospital - Ivy Elite Institute of Orthopaedics | Recruiting |
Mohali, Punjab, India, 160071 | |
Contact: Jitendra Khatri +91-9814104345 jitendra22khatri@gmail.com | |
Contact: Abhijit Katyarmal 0172-7170000 abhijit.chandigarh@gmail.com | |
Principal Investigator: Manuj Wadhwa, M.D. | |
Sub-Investigator: Ritesh Khokhar | |
Italy | |
Instituto Clinico Sant'Ambrogio | Not yet recruiting |
Milan, Italy, 20149 | |
Contact: Bruno Violante Violante 2.331271 violante.b@gmaiI.com | |
Principal Investigator: Bruno Violante Violante | |
Korea, Republic of | |
Chonnam National University Hwasun Hospital | Recruiting |
Hwasun, Jeonranam-do, Korea, Republic of, 58128 | |
Contact: Young-Ye Park +82-61-379-7892 dadosea251@daum.net | |
Principal Investigator: Jong-Keun Seon | |
Sub-Investigator: Seung Min Na | |
Sub-Investigator: Ik-Sun Choi | |
Gachon University Gil Medical Center | Recruiting |
Incheon, Korea, Korea, Republic of, 21565 | |
Contact: Hee Keun Kang +32-82-460-3384 happy@gilhospital.com | |
Contact: SooJeong Lee +82-32-460-3213 sjlee@gilmdc.com | |
Principal Investigator: Jae Ang Sim, M.D. | |
Sub-Investigator: Hyuk Min Kwon | |
Sub-Investigator: Ji Hyeon Park |
Principal Investigator: | Jae Ang Sim, M.D. | Gachon University Gil Medical | |
Principal Investigator: | Manuj Wadhwa, M.D. | Ivy Hospital - Ivy Elite Institute of Orthopaedics |
Responsible Party: | Smith & Nephew Pte Ltd |
ClinicalTrials.gov Identifier: | NCT03885622 |
Other Study ID Numbers: |
17-4065-07 |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | January 6, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
NIDJD ANTHEM™ CR Total Knee System |
Joint Diseases Osteoarthritis Musculoskeletal Diseases Arthritis Rheumatic Diseases |