An observational study in Arthroplasty, Replacement, Knee, sponsored by Smith & Nephew, Inc.. Active, not recruiting at 8 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Smith & Nephew, Inc. · Observational
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
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.
Smith & Nephew, Inc. is the lead sponsor of 132 studies on the registry; 10 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects undergoing primary total knee arthroplasty.
Exclusion Criteria:
Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:
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
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.
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
Time frame: Study participants will be followed for 10 years
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Participant Questionnaire to assess the patients opinion about their knee and associated problems.
Time frame: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years
2011 Knee Society Score (2011 KSS)
Participant questionnaire including a pre-operative section supplying information relating to the current symptoms, knee function, satisfaction with their pre-operative functional activities, and the expectations they have of the results of the total knee arthroplasty. The surgeon then completes information on objective measures such as joint alignment, instability, motions and symptoms.
Time frame: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years
EQ-5D-3L
Participant Questionnaire\_ The EQ-5D-3L questionnaire is a self-rating evaluation questionnaire made up of health status measurements of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participants also evaluate their overall health status using a visual analogue scale.
Time frame: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5, 7.5 and 10 years
Femoral Fit ('Perfect Fit' rate)
For each individual knee, 'overall femoral component fit' across the combined three femur levels; condylar, junctional and trochlear will be characterised under three classifications: 1. Perfect Fit: just fit at all three levels or just fit at two levels and underhang at one 2. Overhang: overhang observed on at least one of the three levels 3. Underhang: underhang at all three levels or underhang at two and just fit at one
Time frame: 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.
The Knee X Rays taken during the course of the study will include Full leg weight-bearing, bilateral anteroposterior (AP), lateral and patellar radiographs. The knee assessments to be made from radiographs will include: Radiographic findings; Component orientation; Radiolucencies; Migration; Osteolysis and Stress shielding.
Time frame: Radiographic assessments to be conducted at Pre-operation timepoint (Baseline), post-operative (Day 1), 6 weeks, 1,2, 5, and 10 years
Revision for any reason
Anthem implant revision done for any reason
Time frame: Anytime during the 10 year study period
Adverse Events
All adverse events captured during the entire study period to provide patient safety oversight
Time frame: Adverse events are collected at any time during the study with formal timepoints being at surgery, 6 weeks, 1,2, 5, 7.5 and 10 years
Plan to share: No
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This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Smith & Nephew, Inc.