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

NCT03078543 | Active Not Recruiting FDA Device

• 2 other identifiers: 14-4065-09OREM-ANTHEM-PMCFU
• Study Type: observational
• Target: 148
• Locations: 5 countries
• Sites: 8

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

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Ten year Anthem knee implant survivorship

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

  Study participants will be followed for 10 years

Secondary Outcomes (7)

• Knee injury and Osteoarthritis Outcomes Score (KOOS)

  Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years

• 2011 Knee Society Score (2011 KSS)

  Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years

• EQ-5D-3L

  Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5, 7.5 and 10 years

• Femoral Fit ('Perfect Fit' rate)

  Femoral Fit will be measured at surgery, assessed for an estimated 1 hour

• Radiographic Assessments to adequately assess the component position, prosthesis-bone interface, and the knee alignment.

  Radiographic assessments to be conducted at Pre-operation timepoint (Baseline), post-operative (Day 1), 6 weeks, 1,2, 5, and 10 years

Study Arms (1)

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

Device: ANTHEM™ PS Total Knee System implant

Interventions

ANTHEM™ PS Total Knee System implant 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.

ANTHEM™ PS Total Knee System implant

Eligibility Criteria

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

Study Population

Subjects undergoing primary total knee arthroplasty.

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 is male or female between the ages of 18 and 75 years of age
• Subject plans to be available through ten (10) years post-operative follow-up
• Subject agrees to follow the study protocol

You may not qualify if:

• Subject would receive the ANTHEM™ Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
• Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
• Subject has a history of patellar fracture, patellectomy, 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 total knee or unicondylar knee arthroplasty
• Subject has an active infection or sepsis (treated or untreated)
• 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 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).
• Subject is pregnant or plans to become pregnant during the study
• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (8)

Beijing Jishuitan Hospital, Institute of Orthopedics & Traumatology,

Beijing, Beijing Municipality, 100035, China

Location

Instituto Clinico Sant'Ambrogio

Milan, Milan, 20149, Italy

Location

Fatebenefratelli Isola Tiberina Gemelli Hospital - Isle of Rome

Roma, 00186, Italy

Location

Westville Hospital

Durban, KwaZulu-Natal, 3630, South Africa

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam, 626-770, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasan, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

Study Officials

• Julian Yang

  Smith & Nephew Medical (Shanghai) Limited

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: March 13, 2017
• Study Start: June 28, 2017
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1); IT (2); ZA (1); CN (1); KR (3)