Clinical trial NCT02445443: LEGION Hinge Safety and Efficacy Study
Official title: A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Arthroplasty, Total
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a revision total knee arthroplasty (TKA) using the LEGION Hinge Total Knee system.

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).

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.

Eligibility 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

Primary outcomes:
measure: Original Knee Society Clinical Score© (KSCS)
timeFrame: 1 year
measure: Revision
timeFrame: Up to 5 years
Secondary outcomes:
measure: Original Knee Society Functional Score© (KSFS)
timeFrame: 1 year
measure: Original Knee Society Functional Score© (KSFS)
timeFrame: 2 years
measure: 2011 Knee Society Score©
timeFrame: 1 year
measure: 2011 Knee Society Score©
timeFrame: 2 years
measure: EQ-5D-3L™
timeFrame: 1 year
measure: EQ-5D-3L™
timeFrame: 2 years
measure: Original Knee Society Clinical Score© (KSCS)
timeFrame: 2 Years
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals
state: Iowa
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Pellenberg
country: Belgium
facility: UZ Leuven campus Pellenberg
city: Winnipeg
country: Canada
facility: Concordia Hip and Knee Institute
state: Manitoba
city: Terrassa
country: Spain
facility: University Hospital Mutua de Terrassa
state: Barcelona
Study officials:
References: