Safety and Efficacy of the ANTHEM™ CR Total Knee System

NCT03885622 | Active Not Recruiting

• 1 other identifier: 17-4065-07
• Study Type: observational
• Target: 153
• Locations: 4 countries
• Sites: 8

Brief 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. Clinical, radiographic, Health Economic Outcomes and safety outcomes will be evaluated.

Conditions

Non-inflammatory Degenerative Joint Disease

Keywords

NIDJD; ANTHEM™ CR Total Knee System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in implant fixation measured by radiographic assessment

  6 weeks, 1 year, 2 years, and 5 years

• Change in bone integrity measured by radiographic assessment

  6 weeks, 1 year, 2 years, and 5 years

• Number of Adverse Events

  6 weeks, 1 year, 2 years, and 5 years

• Quality of life measured by EQ-5D-3L

  6 weeks, 1 year, 2 years, and 5 years

• Pain as measured by Knee Society Score (2011 KSS)

  6 weeks, 1 year, 2 years, and 5 years

Interventions

ANTHEM™ CR Total Knee System DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Smith & Nephew Pte Ltd: lead

Study Sites (8)

Parekhs Hospital

Ahmedabad, Gujarat, 380015, India

Location

Aadhar Health Institute

Hisar, Haryana, 125001, India

Location

Ivy Hospital - Ivy Elite Institute of Orthopaedics

Mohali, Punjab, 160071, India

Location

Instituto Clinico Sant'Ambrogio

Milan, Milan, 20149, Italy

Location

Istituto Clinico San Siro

Milan, 20148, Italy

Location

Westville Hospital

Westville, Durban, 3630, South Africa

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeonranam-do, 58128, South Korea

Location

Gachon University Gil Medical Center

Incheon, Korea, 21565, South Korea

Location

Study Officials

• Jae Ang Sim, M.D.

  Gachon University Gil Medical

  PRINCIPAL INVESTIGATOR

• Manuj Wadhwa, M.D.

  Ivy Hospital - Ivy Elite Institute of Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: March 21, 2019
• Study Start: November 23, 2018
• Primary Completion (Estimated): April 3, 2034
• Study Completion (Estimated): August 1, 2034
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

KR (2); IN (3); IT (2); ZA (1)