Non-inflammatory Degenerative Joint DiseaseAnthem CRNCT03885622
Safety and Efficacy of the ANTHEM™ CR Total Knee System
An observational study of Non-inflammatory Degenerative Joint Disease, run by Smith & Nephew Pte Ltd at 8 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease
- What is being tested?
- ANTHEM™ CR Total Knee System
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 23 Nov 2018to 1 Aug 2034
- Phase
- Observational
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: A minimum of 153 subjects undergoing total knee arthroplasty for degenerative joint disease will be implanted with ANTHEM™ CR Total Knee System.
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 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 ten (10) years postoperative follow-up.
- Subject agrees to follow the study protocol.
- Subject has achieved skeletal maturity as deemed by enrolling investigator.
Who cannot join
- 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.
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 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.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
India3 sites
Parekhs Hospital
Ahmedabad, Gujarat, 380015
Aadhar Health Institute
Hisar, Haryana, 125001
Ivy Hospital - Ivy Elite Institute of Orthopaedics
Mohali, Punjab, 160071
Italy2 sites
Instituto Clinico Sant'Ambrogio
Milan, Milan, 20149
Istituto Clinico San Siro
Milan, 20148
South Korea2 sites
Chonnam National University Hwasun Hospital
Hwasun, Jeonranam-do, 58128
Gachon University Gil Medical Center
Incheon, Korea, 21565
About this study
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
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.
Read the 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).
- Being tested
- ANTHEM™ CR Total Knee System
- Keywords
- NIDJD, ANTHEM™ CR Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTHEM™ CR Total Knee SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Inferiority 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.
Measured: 10 years postoperatively
Secondary outcomes (5)
Change in implant fixation measured by radiographic assessment
based on comparison of antero posterior and lateral radiographs
Measured: 6 weeks, 1 year, 2 years, and 5 years
Change in bone integrity measured by radiographic assessment
based on comparison of antero-posterior and lateral radiographs
Measured: 6 weeks, 1 year, 2 years, and 5 years
Number of Adverse Events
Number and frequency of all types adverse events
Measured: 6 weeks, 1 year, 2 years, and 5 years
Quality of life measured by EQ-5D-3L
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.
Measured: 6 weeks, 1 year, 2 years, and 5 years
Pain as measured by Knee Society Score (2011 KSS)
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.
Measured: 6 weeks, 1 year, 2 years, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start23 Nov 2018
- Primary completion3 Apr 2034 (estimated)
- Study completion1 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Degenerative Joint DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Ang Sim, M.D., Principal investigator, Gachon University Gil MedicalManuj Wadhwa, M.D., Principal investigator, Ivy Hospital - Ivy Elite Institute of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885622
- Sponsor's protocol ID
- 17-4065-07
- Acronym
- Anthem CR
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2019
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No