Legion Primary Safety and Efficacy

Study Overview
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Brief Summary
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This study will look at the health results of using the LEGION™ Primary Knee System over a period of ten (10) years. This type of surgery uses an artificial knee made of plastic and metal. This study will enter subjects who suffer from a variety of conditions that have caused at least one of their knees to become nonfunctional. You are being asked to participate in the study because you have significant problems with your knee(s) and your study surgeon has determined that your knee(s) must be surgically replaced to improve your condition. If you decided to participate in this study, you will be one of approximately one hundred thirty-eight (138) subjects in the study.

Detailed Description
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This is a prospective, consecutive series, multi-center clinical study of the LEGION™ Total Knee System. The study design was selected to assess the safety and effectiveness profile of the LEGION™ Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Subjects meeting the entrance criteria specified in this protocol will be approached to participate in the study and enrolled sequentially. Any consenting subjects meeting the inclusion criteria are not to be excluded unless they do not consent to participate. A nonrandomized, consecutive series of up to 138 subjects will be enrolled at a maximum of 8 research sites, with an expectation of 18 subjects (up to a maximum of 28 subjects) to be enrolled at each site. When 138 subjects are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. Sites will be selected for participation in the study at the discretion of Smith & Nephew. Follow-up clinical assessments will be at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years. Each subject will receive a standard radiographic evaluation at discharge that will be used for baseline analysis. Additional radiographic analysis will be performed at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.

Official Title
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A Prospective, Multi-Center, Non-Randomized, Safety and Efficacy Clinical Study of the LEGION Primary Knee System for Primary Total Knee Replacement in Subject With Degenerative Knee Disease

Conditions
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Osteo Arthritis Knee, Total Knee Replacement

Intervention / Treatment
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* Procedure: Total Knee Arthroplasty using Legion Total Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the inclusion criteria: Subject is a candidate for the LEGION™ Primary Knee System according to the instructions for use Subject is of legal age and skeletally mature Subject is willing to sign and date an ethics-approved consent form and participate in the study Subject is willing to be available for ten-year follow-up postoperatively. Exclusion Criteria: Subjects must not meet any of the exclusion criteria: Subject with immunosuppressive disorders Subject has grossly insufficient femoral or tibial bone stock Subject has an active localized or systemic infection Subject is pregnant Subject psychological or neurological conditions that would impair the subject's ability or willingness to restrict activities or follow medical advice during the course of this study Subject is a prisoner.

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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Legion Primary<br>Legion Primary TKA | Procedure: Total Knee Arthroplasty using Legion Total Knee System<br>* Primary Total Knee Arthroscopy using Legion Total Knee System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival Rate |  | Did implant survive with no revision through 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical and Device related Adverse Events | All AEs will be collected and reported. | Through 10 years | 
| Knee Society Score (KSS) 2011 | The new Knee Society Score is composed of five components: Patient Demographics Objective Knee Score - completed by the surgeon. Patient Expectations - completed by the patient Patient Satisfaction Score - completed by the patient Functional Knee Score- completed by the patient. Patient Demographics This section is self-explanatory and includes a detailed modification of the Charnley Functional Classification. This should be included at each evaluation period since the functional classification can change with length of follow-up. Objective Knee Score The new score is not significantly different from the objective knee score of the original KSS. Unlike the old scoring system the new objective score allows for more than 100 points in | 10 years | 
| Knee Osteoarthritis Outcome Score (KOOS) | Assesses Symptoms and Stiffness, Pain, Function and Daily Living, Function in sports and recreational activity, and Quality of Life. The five patient-relevant subscales of KOOS are scored separately: Pain (nine items) Symptoms (seven items) ADL Function (17 items) Sport and Recreation Function (five items) Quality of Life (four items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. An aggregate score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. | Through 10 years | 
| Radiographic Evaluation | Perform weight bearing AP and lateral standard x-rays | Through 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Legion Primary, TKA, Osteoarthritis of Knee