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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component | Device | LEGION Porous HA Tibial Baseplate (with and without holes) and/or the LEGION Porous HA CR Femoral Component |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survivorship 10 years post-surgery | 10 years |
| 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 |
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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).
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Karlie Morgan | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Twin Cities Orthopedics | Coon Rapids | Minnesota | 55434 | United States | ||
| Saint Louis University Hospital, Dept. of Orthopaedic Surgery |
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| 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 |
| St Louis |
| Missouri |
| 63104 |
| United States |