Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Multi-center Study of the Safety and Performance of Primary Total Knee Arthroplasty With LEGION™ Porous HA Tibial Baseplates (With and Without Holes) and/or the LEGION™ Porous HA CR Femoral Component in US Centers

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject received primary TKA with the LEGION Porous HA Tibial Baseplates (either with holes or without holes) and/or the LEGION Porous HA CR Femoral Component, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, or degenerative arthritis). 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): Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form. Subject must be available through ten (10) years postoperative follow-up. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English. 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 received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty Subject has ipsilateral hip arthritis resulting in flexion contracture. At the time of enrollment, 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 a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease). Subject has a known allergy to one or more of its components of the study device. 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: Subject, in the opinion of the Principal Investigator (PI), 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. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits. Subject is found to have had a revision of the study device(s).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component|LEGION Porous HA Tibial Baseplate (with and without holes) and/or the LEGION Porous HA CR Femoral Component|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survivorship 10 years post-surgery |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life - KOOS JR | Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS JR) questionnaire | 10 years | 
| Quality of Life - Forgotten Joint Score (FJS) | Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire | 10 years | 
| Quality of life - EQ-5D-5L | Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire | 10 years | 
| Implant survivorship | Implant Survivorship at 5 years defined as the cumulative proportion of knee-implanted components without a revision | 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. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Legion