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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System
Secondary ID [1] 0 0
13-4042-01
Universal Trial Number (UTN)
Trial acronym
LINKS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Arthroplasty, Total 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Original Knee Society Clinical Score© (KSCS)
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Revision
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Original Knee Society Functional Score© (KSFS)
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Original Knee Society Functional Score© (KSFS)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
2011 Knee Society Score©
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
2011 Knee Society Score©
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
EQ-5D-3L™
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
EQ-5D-3L™
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Original Knee Society Clinical Score© (KSCS)
Timepoint [7] 0 0
2 Years

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2028
Actual
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [2] 0 0
Orthopaedics WA St John of God Hospital Murdoch - Murdoch
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Belgium
State/province [5] 0 0
Pellenberg
Country [6] 0 0
Canada
State/province [6] 0 0
Manitoba
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02445443