LEGION Hinge Safety and Efficacy Study (LINKS)

A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System

The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Device: LEGION Hinge Knee System

Detailed Description

The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 and 2 years in subjects using the LEGION™ Hinge Knee System. The focus of the 1 and 2 year analyses will be on safety and efficacy. The 5 year analysis will focus on survivorship and safety.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Hospital
• Belgium
  • Pellenberg, Belgium, 3212
    • UZ Leuven campus Pellenberg
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 2M9
      • Concordia Hip and Knee Institute
• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • University Hospital Mutua de Terrassa
• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals
  • New York
    • New York, New York, United States, 10003
      • NYU Hospital for Joint Diseases
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a revision total knee arthroplasty (TKA) using the LEGION Hinge Total Knee system.

Description

Inclusion Criteria:

• Subject has gross knee instability resulting from loss of collateral ligament function, gross bone loss, comminuted fractures of the proximal tibia or distal femur, rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, unicompartmental replacement or total knee replacement, or absent or incompetent posterior cruciate ligament and one or both of the collateral ligaments
• Subject has a failed primary or revision knee replacement
• Subject is 18-80 years of age
• Subject is skeletally mature in Investigator's judgment i.e., subject is not actively growing or does not have immature bones for any reason
• Subject has met an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological, infection or other conditions that would pose excessive operative risk
• Subject is willing to sign and date an IRB/EC-approved consent form
• Subject plans to be available through the five (5) year postoperative follow-up
• If of child bearing potential, Subject reports she is not pregnant nor plans to become pregnant during the study
• Subject agrees to follow the study protocol

Exclusion Criteria:

• Subject is receiving the study device as a primary knee replacement
• Subject has presence of malignant tumor, metastatic, or neoplastic disease
• Subject is not expected to return to normal ambulatory function (i.e., morbid obesity or other limiting co-morbidities)
• Subject is pregnant or plans to become pregnant during the course of the study
• Subject has conditions that may interfere with the revision arthroplasty survival or outcome (i.e., Paget's or Charcot-Marie-Tooth disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
• Subject has known (Subject reported) metal hypersensitivity
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in this study
• Subject has BMI>45
• Subject is participating in any other pharmaceutical, biologic, or medical device clinical investigation or has been treated with an investigational product in the past 30 days
• Subject is facing current or impending incarceration
• Subject is not a good candidate for the study based on Investigator opinion

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LEGION Hinge Knee System; This group will be receiving the LEGION Hinge device.	Device: LEGION Hinge Knee System; All enrolled/treated subjects will receive the LEGION Hinge Knee System.; Other Names: LEGION HK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Original Knee Society Clinical Score© (KSCS)	The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The KSCS will be administered at the pre-operative visit and all follow-up visits. The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.	1 year
Revision	Revision, for any reason, will be assessed throughout the subject's participation in the study.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Original Knee Society Functional Score© (KSFS)	The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.	1 year
Original Knee Society Functional Score© (KSFS)	The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.	2 years
2011 Knee Society Score©	2011 Knee Society Knee Score and all of it's components	1 year
2011 Knee Society Score©	2011 Knee Society Knee Score and all of it's components	2 years
EQ-5D-3L™	The EuroQol EQ-5D-3L™ is a descriptive system measuring health-related Quality Of Life (QOL) and consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D-3L™ dimension. The EQ-5D-3L™ is completed by the Subject on the day of their visit.	1 year
EQ-5D-3L™	The EuroQol EQ-5D-3L™ is a descriptive system measuring health-related Quality Of Life (QOL) and consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D-3L™ dimension. The EQ-5D-3L™ is completed by the Subject on the day of their visit.	2 years
Original Knee Society Clinical Score© (KSCS)	The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The KSCS will be administered at the pre-operative visit and all follow-up visits. The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.	2 Years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Rachael Winter, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2015
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimated): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 13-4042-01