LEGION™ Primary Safety and Efficacy

Not Applicable

Terminated

Conditions: Osteo Arthritis Knee
Total Knee Replacement

Registration Number: NCT04040985

Lead Sponsor: Smith & Nephew, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 128

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Implant Survivorship Percentage	Postoperatively through 120 months	Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months

Secondary Outcome Measures

Name	Time	Method
Knee Society Score (KSS) - Performance	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	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.
Knee Society Score (KSS) - Function	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	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.
Knee Osteoarthritis Outcome Score (KOOS) - Pain	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	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.
Knee Osteoarthritis Outcome Score (KOOS) - Symptom	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	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.
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL)	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	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.
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	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.
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL)	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	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.
Radiographic Evaluation - Radiolucent Lines	Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years	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
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence	Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years	Performed weight bearing AP and lateral standard x-rays to identify knees that observed periosteal hypertrophy, implant loosening, osteolysis or subsidence (Yes/No).
Radiographic Evaluation - Observed Patellar Problem	Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years	Performed weight bearing AP and lateral standard x-rays to identify knees that observed patellar problems (Yes/No).

Trial Locations

Locations (5): 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
Orthopaedic Associates of Vero Beach
🇺🇸Vero Beach, Florida, United States