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

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: Active, not recruiting
• Conditions: Non-inflammatory Degenerative Joint Disease
• Intervention / Treatment: Device: ANTHEM™ CR Total Knee System

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: Observational
• Enrollment (Actual): 153

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in implant fixation measured by radiographic assessment	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	based on comparison of antero-posterior and lateral radiographs	6 weeks, 1 year, 2 years, and 5 years
Number of Adverse Events	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	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)	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

• Sponsor: Smith & Nephew Pte Ltd
• Investigators: 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

Study Major Dates

• Study Start (Actual): November 23, 2018
• Primary Completion (Estimated): April 3, 2034
• Study Completion (Estimated): August 1, 2034

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NIDJD; ANTHEM™ CR Total Knee System
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID 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