LEGION™ Primary Safety and Efficacy

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteo Arthritis Knee; Total Knee Replacement
• Intervention / Treatment: Procedure: Total Knee Arthroplasty using LEGION™ Total Knee System

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Vero Beach, Florida, United States, 32960
      • Orthopaedic Associates of Vero Beach
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Orthopaedic Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Louisville Bone & Joint Specialist, PSC
  • New Jersey
    • Monroe, New Jersey, United States, 08831
      • University Hip and Knee Specialists
    • Somerset, New Jersey, United States, 08873
      • University Orthopaedic Associates, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LEGION™ Primary; LEGION™ Primary Total Knee Arthroplasty (TKA)	Procedure: Total Knee Arthroplasty using LEGION™ Total Knee System; Primary Total Knee Arthroscopy using LEGION™ Total Knee System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Postoperatively through 120 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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	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).	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).	Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2009
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis of Knee; TKA; LEGION™ Primary
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 10-K300-95301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No