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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02445443
Registration number
NCT02445443
Ethics application status
Date submitted
30/04/2015
Date registered
15/05/2015
Date last updated
8/11/2023
Titles & IDs
Public title
LEGION Hinge Safety and Efficacy Study
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Scientific title
A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System
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Secondary ID [1]
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13-4042-01
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Universal Trial Number (UTN)
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Trial acronym
LINKS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee Arthroplasty, Total
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - LEGION Hinge Knee System
LEGION Hinge Knee System - This group will be receiving the LEGION Hinge device.
Treatment: Devices: LEGION Hinge Knee System
All enrolled/treated subjects will receive the LEGION Hinge Knee System.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Original Knee Society Clinical Score© (KSCS)
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Assessment method [1]
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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.
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Timepoint [1]
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1 year
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Primary outcome [2]
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Revision
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Assessment method [2]
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Revision, for any reason, will be assessed throughout the subject's participation in the study.
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Timepoint [2]
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Up to 5 years
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Secondary outcome [1]
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Original Knee Society Functional Score© (KSFS)
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Assessment method [1]
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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.
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Timepoint [1]
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1 year
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Secondary outcome [2]
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Original Knee Society Functional Score© (KSFS)
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Assessment method [2]
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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.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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2011 Knee Society Score©
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Assessment method [3]
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2011 Knee Society Knee Score and all of it's components
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Timepoint [3]
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1 year
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Secondary outcome [4]
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2011 Knee Society Score©
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Assessment method [4]
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2011 Knee Society Knee Score and all of it's components
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Timepoint [4]
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2 years
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Secondary outcome [5]
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EQ-5D-3L™
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Assessment method [5]
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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.
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Timepoint [5]
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1 year
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Secondary outcome [6]
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EQ-5D-3L™
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Assessment method [6]
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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.
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Original Knee Society Clinical Score© (KSCS)
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Assessment method [7]
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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.
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Timepoint [7]
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2 Years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
47
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Fremantle Hospital - Fremantle
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Recruitment hospital [2]
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Orthopaedics WA St John of God Hospital Murdoch - Murdoch
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Recruitment postcode(s) [1]
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6160 - Fremantle
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Recruitment postcode(s) [2]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Iowa
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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Oregon
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Belgium
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State/province [5]
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Pellenberg
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Country [6]
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Canada
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State/province [6]
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Manitoba
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Country [7]
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Spain
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State/province [7]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02445443
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02445443
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