An observational study in Total Knee Arthroplasty, sponsored by Smith & Nephew, Inc.. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Smith & Nephew, Inc. · Observational
The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants for 10 years post-surgery.
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.
Maximum of 150 subjects enrolled to obtain a minimum of 150 implanted components:
Note: Some subjects may have received both the LEGION Porous HA Tibial Baseplate (with or without holes) and the LEGION Porous HA CR Femoral Component during their TKA procedure.
Subject received primary TKA between 24 and 60 months prior to the time of consent.
Inclusion criteria for prospective follow-up (subjects must meet criteria 1 \& 2 from above and criteria 3,4 and 5 below):
Exclusion Criteria:
Exclusion criteria for retrospective chart review - Any one (1) of the following criteria will disqualify a potential subject from participation in the retrospective chart review:
Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
Exclusion criteria for prospective follow-up - Any one (1) of the criteria from 1-6 above will disqualify a potential subject from participation in the prospective follow-up) as will any one (1) of the below criteria 7, 8 and 9:
LEGION Porous HA Tibial Baseplate (with and without holes) and/or the LEGION Porous HA CR Femoral Component
Implant survivorship 10 years post-surgery
Time frame: 10 years
Quality of life - KOOS JR
Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS JR) questionnaire
Time frame: 10 years
Quality of Life - Forgotten Joint Score (FJS)
Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire
Time frame: 10 years
Quality of life - EQ-5D-5L
Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire
Time frame: 10 years
Implant survivorship
Implant Survivorship at 5 years defined as the cumulative proportion of knee-implanted components without a revision
Time frame: 5 years
Radiographic findings
X-ray of implanted knee- 3 views (AP, Lateral and Skyline/Merchant) to observe any radiographic findings that may include; Heterotopic ossification, oteolysis, femoral notching, evidence of poly wear, radiolucencies.
Time frame: 10 years
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Smith & Nephew, Inc.