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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
128
Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Orthopaedic Associates of Vero Beach
Vero Beach, Florida, United States
Iowa Orthopaedic Center
Des Moines, Iowa, United States
Louisville Bone & Joint Specialist, PSC
Louisville, Kentucky, United States
University Hip and Knee Specialists
Monroe, New Jersey, United States
University Orthopaedic Associates, LLC
Somerset, New Jersey, United States
Implant Survivorship Percentage
Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months
Time frame: Postoperatively through 120 months
Knee Society Score (KSS) - Performance
The Knee Society Score (KSS) performance outcome comprised information on objective knee indicators related to everyday activities. The Performance Score ranged from 0 to 100 with a higher score indicating a better outcome.
Time frame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Society Score (KSS) - Function
The Knee Society Score (KSS) function outcome comprised information on functional knee indicators related to walking \& standing, standard activities, advanced activities, and discretionary activities. The Function Score ranged from 0 to 100 with a higher score indicating a better outcome.
Time frame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Osteoarthritis Outcome Score (KOOS) - Pain
The Knee Osteoarthritis Outcome Score (KOOS) Pain subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.
Time frame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Osteoarthritis Outcome Score (KOOS) - Symptom
The Knee Osteoarthritis Outcome Score (KOOS) Symptom subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.
Time frame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL)
The Knee Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.
Time frame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities
The Knee Osteoarthritis Outcome Score (KOOS) Sports and Recreational Activities subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.
Time frame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL)
The Knee Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.
Time frame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Radiographic Evaluation - Radiolucent Lines
Performed weight bearing AP and lateral standard x-rays to identify knees with presence or absence of radiolucent lines categorized as: * Findings in Femoral Zone * Findings in Tibial Mediolateral (ML) Zone * Findings in Tibial Anteroposterior (AP) Zone * Findings in Patella Zone * No Radiolucent Lines Found
Time frame: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence
Performed weight bearing AP and lateral standard x-rays to identify knees that observed periosteal hypertrophy, implant loosening, osteolysis or subsidence (Yes/No).
Time frame: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years
Radiographic Evaluation - Observed Patellar Problem
Performed weight bearing AP and lateral standard x-rays to identify knees that observed patellar problems (Yes/No).
Time frame: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years
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