Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System

NCT ID: NCT03078543

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-28
• Study Completion Date: 2029-04-30

Brief Summary

The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature

Detailed Description

The ANTHEM PS Study is a prospective, multicentre, cohort study to collect relevant patient reported, clinical, surgical and radiological data from 143 subjects implanted with the ANTHEM™PS Knee System for degenerative joint disease in up to 6 clinical sites globally. Total study duration for study participants will be 10 years with post-operative follow-up visits planned for 6 weeks, 1 year, 2 years, 5 years, 7.5 years and 10 years. The study will evaluate the 10 year implant survivorship and the safety and outcome of the ANTHEM™PS Knee System over 10 years. This is a post-market study of the ANTHEM™PS Total Knee System.

The primary objective of the study is to demonstrate non-inferiority (8% margin) of 10 year implant survivorship of the ANTHEM™PS Total Knee System in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature.

The secondary objectives of the study are to evaluate shorter and long term safety and outcomes of the ANTHEM™ PS Total Knee System.

• Knee injury and Osteoarthritis Outcomes Score (KOOS)
• 2011 Knee Society Score (2011 KSS)
• EQ-5D - 3L
• Femoral Fit ('Perfect Fit' rate)
• Radiographic Assessment
• Revision for any reason
• Adverse Events (AEs)

Conditions

Arthroplasty, Replacement, Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ANTHEM™ PS Total Knee System implant

The ANTHEM™ PS Total Knee System will demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature

ANTHEM™ PS Total Knee System implant

Intervention Type: DEVICE

The ANTHEM™ PS Total Knee System is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties. The ANTHEM™ PS Total Knee System consists of the following components:

• Cobalt-Chrome (Co-Cr) femoral components - Posterior stabilised
• Titanium primary tibial components
• Posterior-stabilised ultra-high molecular weight polyethylene (UHMWPE)
• Polyethylene patella components The resulting product is sufficient to accommodate a wide range of clinical applications.

Interventions

ANTHEM™ PS Total Knee System implant

The ANTHEM™ PS Total Knee System is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties. The ANTHEM™ PS Total Knee System consists of the following components:

• Cobalt-Chrome (Co-Cr) femoral components - Posterior stabilised
• Titanium primary tibial components
• Posterior-stabilised ultra-high molecular weight polyethylene (UHMWPE)
• Polyethylene patella components The resulting product is sufficient to accommodate a wide range of clinical applications.

Intervention Type: DEVICE

Eligibility Criteria

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 is male or female between the ages of 18 and 75 years of age

4. Subject plans to be available through ten (10) years post-operative follow-up

5. Subject agrees to follow the study protocol

Exclusion Criteria

1. Subject would receive the ANTHEM™ Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty

2. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty

3. Subject has a history of patellar fracture, patellectomy, 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 total knee or unicondylar knee arthroplasty

8. Subject has an active infection or sepsis (treated or untreated)

9. Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated

10. 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)

11. Subject has a chronic, contralateral lower extremity condition causing abnormal ambulation, which is not related to the knee (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).

12. Subject is pregnant or plans to become pregnant during the study

13. 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

14. Subject has a BMI>40

15. Subject is enrolled in another investigational drug, biologic, or device study

16. Subject is facing current or impending incarceration

17. Subject has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Yang

Role: STUDY_DIRECTOR

Smith & Nephew Medical (Shanghai) Limited

Locations

Beijing Jishuitan Hospital, Institute of Orthopedics & Traumatology,

Beijing, Beijing Municipality, China

Instituto Clinico Sant'Ambrogio

Milan, Milan, Italy

Fatebenefratelli Isola Tiberina Gemelli Hospital - Isle of Rome

Roma, , Italy

Westville Hospital

Durban, KwaZulu-Natal, South Africa

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam, South Korea

Chonnam National University Hwasun Hospital

Hwasan, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Siriraj Hospital

Bangkok, Bangkok, Thailand

Countries

China; Italy; South Africa; South Korea; Thailand

Other Identifiers

OREM-ANTHEM-PMCFU

Identifier Type: OTHER

Identifier Source: secondary_id

14-4065-09

Identifier Type: -

Identifier Source: org_study_id