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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02445443




Registration number
NCT02445443
Ethics application status
Date submitted
30/04/2015
Date registered
15/05/2015
Date last updated
4/10/2019

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) - 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.
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Revision - Revision, for any reason, will be assessed throughout the subject's participation in the study.
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
2011 Knee Society Score© - 2011 Knee Society Knee Score and all of it's components
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
2011 Knee Society Score© - 2011 Knee Society Knee Score and all of it's components
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
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.
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Oregon
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Belgium
State/province [4] 0 0
Pellenberg
Country [5] 0 0
Canada
State/province [5] 0 0
Manitoba
Country [6] 0 0
Spain
State/province [6] 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
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).
Trial website
https://clinicaltrials.gov/show/NCT02445443
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stacy Leake-Gardner
Address 0 0
Smith & Nephew, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stacy Leake-Gardner, RN
Address 0 0
Country 0 0
Phone 0 0
+1 901-399-5893
Fax 0 0
Email 0 0
stacy.leake-Gardner@smith-nephew.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02445443