LEGION Hinge Safety and Efficacy Study

Knee Arthroplasty, Total Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02445443
• Other study ID #: 13-4042-01
• Status: Active, not recruiting
• Start date: June 30, 2015
• Est. completion date: August 1, 2028

Study information

• Verified date: November 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: August 1, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty, Total

Intervention

Device:
• LEGION Hinge Knee System
All enrolled/treated subjects will receive the LEGION Hinge Knee System.

Locations

Country	Name	City	State
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	Orthopaedics WA St John of God Hospital Murdoch	Murdoch	Western Australia
Belgium	UZ Leuven campus Pellenberg	Pellenberg
Canada	Concordia Hip and Knee Institute	Winnipeg	Manitoba
Spain	University Hospital Mutua de Terrassa	Terrassa	Barcelona
United States	University of Iowa Hospitals	Iowa City	Iowa
United States	Hospital for Special Surgery	New York	New York
United States	NYU Hospital for Joint Diseases	New York	New York
United States	Baylor Research Institute at Baylor Regional Medical Center Plano	Plano	Texas
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Revision	Revision, for any reason, will be assessed throughout the subject's participation in the study.	Up to 5 years
Secondary	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
Secondary	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
Secondary	2011 Knee Society Score©	2011 Knee Society Knee Score and all of it's components	1 year
Secondary	2011 Knee Society Score©	2011 Knee Society Knee Score and all of it's components	2 years
Secondary	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
Secondary	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
Secondary	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