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LEGION Hinge Safety and Efficacy Study (LINKS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02445443
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment
Knee Arthroplasty, Total 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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System
Actual Study Start Date : June 30, 2015
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : March 1, 2025

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 Name: LEGION HK




Primary Outcome Measures :
  1. Original Knee Society Clinical Score© (KSCS) [ Time Frame: 1 year ]
    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. Revision [ Time Frame: Up to 5 years ]
    Revision, for any reason, will be assessed throughout the subject's participation in the study.


Secondary Outcome Measures :
  1. Original Knee Society Functional Score© (KSFS) [ Time Frame: 1 year ]
    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. Original Knee Society Functional Score© (KSFS) [ Time Frame: 2 years ]
    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.

  3. 2011 Knee Society Score© [ Time Frame: 1 year ]
    2011 Knee Society Knee Score and all of it's components

  4. 2011 Knee Society Score© [ Time Frame: 2 years ]
    2011 Knee Society Knee Score and all of it's components

  5. EQ-5D-3L™ [ Time Frame: 1 year ]
    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.

  6. EQ-5D-3L™ [ Time Frame: 2 years ]
    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.

  7. Original Knee Society Clinical Score© (KSCS) [ Time Frame: 2 Years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445443


Contacts
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Contact: Stacy Leake-Gardner, RN +1 901-399-5893 stacy.leake-Gardner@smith-nephew.com
Contact: Shirley Mak-Parisi 978.749.1459 shirley.mak-parisi@smith-nephew.com

Locations
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United States, New York
NYU Hospital for Joint Diseases Recruiting
New York, New York, United States, 10003
Contact: Ariel Aponte    212-460-0176    Ariel.Aponte@nyumc.org   
Contact: Ivelisse Rodriguez Pagan    212-598-2311    Ivelisse.pagan@nyulangone.org   
Principal Investigator: Ran Schwarzkopf, MD         
Sub-Investigator: Scott Marwin, MD         
Sub-Investigator: James Slover, MD         
Sub-Investigator: Jonathan Vigdorchik, MD         
Hospital for Special Surgery Terminated
New York, New York, United States, 10021
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Erh-ting Hsu       hsuer@ohsu.edu   
Principal Investigator: Thomas Huff, MD         
United States, Texas
Baylor Research Institute at Baylor Regional Medical Center Plano Terminated
Plano, Texas, United States, 75093
Australia, Western Australia
Fremantle Hospital Recruiting
Fremantle, Western Australia, Australia, 6160
Contact: Mary Searle    (08) 9431 3867    mary.searle@health.wa.gov.au   
Contact: Carole Steggall    (08) 9431 3867    carole.steggall@health.wa.gov.au   
Principal Investigator: Piers Yates, MD         
Sub-Investigator: Gareth Prosser, MD         
Orthopaedics WA St John of God Hospital Murdoch Terminated
Murdoch, Western Australia, Australia, 6150
Belgium
UZ Leuven campus Pellenberg Recruiting
Pellenberg, Belgium, 3212
Contact: Kristel Van de loock    016 34 12 66    kristel.vandeloock@uzleuven.be   
Contact: Rowie de Buysscher    +32 16 33 88 18    Rowie.debuysscher@uzleuven.be   
Principal Investigator: Hilde Vandenneucker, MD         
Sub-Investigator: Thomas Luyckx, MD         
Canada, Manitoba
Concordia Hip and Knee Institute Recruiting
Winnipeg, Manitoba, Canada, R2K 2M9
Contact: Sarah Tran    +1 204 926 1231    stran@orthoinno.com   
Principal Investigator: Thomas Turgeon, MD         
Sub-Investigator: Eric Bohm, MD         
Sub-Investigator: Colin Burnell, MD         
Sub-Investigator: David Hedden, MD         
Spain
University Hospital Mutua de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Contact: Laura Olivia Pérez       loliva@mutuaterrassa.cat   
Principal Investigator: Daniel Haro Fernández, MD         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Stacy Leake-Gardner Smith & Nephew, Inc.
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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT02445443    
Other Study ID Numbers: 13-4042-01
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019