Clinical trial NCT04040985: LEGION™ Primary Safety and Efficacy
Official title: A Prospective, Multi-Center, Non-Randomized, Safety and Efficacy Clinical Study of the LEGION™ Primary Knee System for Primary Total Knee Replacement in Subject With Degenerative Knee Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteo Arthritis Knee
Total Knee Replacement
Keywords: LEGION™ Primary
TKA
Osteoarthritis of Knee
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will look at the health results of using the LEGION™ Primary Knee System over a period of ten (10) years. This type of surgery uses an artificial knee made of plastic and metal. This study will enter subjects who suffer from a variety of conditions that have caused at least one of their knees to become nonfunctional. You are being asked to participate in the study because you have significant problems with your knee(s) and your study surgeon has determined that your knee(s) must be surgically replaced to improve your condition. If you decided to participate in this study, you will be one of approximately one hundred thirty-eight (138) subjects in the study.

Detailed description: This is a prospective, consecutive series, multi-center clinical study of the LEGION™ Total Knee System. The study design was selected to assess the safety and effectiveness profile of the LEGION™ Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.

Subjects meeting the entrance criteria specified in this protocol will be approached to participate in the study and enrolled sequentially. Any consenting subjects meeting the inclusion criteria are not to be excluded unless they do not consent to participate. A nonrandomized, consecutive series of up to 138 subjects will be enrolled at a maximum of 8 research sites, with an expectation of 18 subjects (up to a maximum of 28 subjects) to be enrolled at each site. When 138 subjects are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. Sites will be selected for participation in the study at the discretion of Smith \& Nephew.

Follow-up clinical assessments will be at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years. Each subject will receive a standard radiographic evaluation at discharge that will be used for baseline analysis. Additional radiographic analysis will be performed at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.

Eligibility criteria: Inclusion Criteria: Subjects must meet all of the inclusion criteria:

* Subject is a candidate for the LEGION™ Primary Knee System according to the instructions for use
* Subject is of legal age and skeletally mature
* Subject is willing to sign and date an ethics-approved consent form and participate in the study
* Subject is willing to be available for ten-year follow-up postoperatively.

Exclusion Criteria: Subjects must not meet any of the exclusion criteria:

* Subject with immunosuppressive disorders
* Subject has grossly insufficient femoral or tibial bone stock
* Subject has an active localized or systemic infection
* Subject is pregnant
* Subject psychological or neurological conditions that would impair the subject's ability or willingness to restrict activities or follow medical advice during the course of this study
* Subject is a prisoner.

Primary outcomes:
measure: Implant Survivorship Percentage
timeFrame: Postoperatively through 120 months
Secondary outcomes:
measure: Knee Society Score (KSS) - Performance
timeFrame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
measure: Knee Society Score (KSS) - Function
timeFrame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
measure: Knee Osteoarthritis Outcome Score (KOOS) - Pain
timeFrame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
measure: Knee Osteoarthritis Outcome Score (KOOS) - Symptom
timeFrame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
measure: Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL)
timeFrame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
measure: Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities
timeFrame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
measure: Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL)
timeFrame: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
measure: Radiographic Evaluation - Radiolucent Lines
timeFrame: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years
measure: Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence
timeFrame: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years
measure: Radiographic Evaluation - Observed Patellar Problem
timeFrame: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years
Other outcomes:
Locations:
city: Vero Beach
country: United States
facility: Orthopaedic Associates of Vero Beach
state: Florida
city: Des Moines
country: United States
facility: Iowa Orthopaedic Center
state: Iowa
city: Louisville
country: United States
facility: Louisville Bone & Joint Specialist, PSC
state: Kentucky
city: Monroe
country: United States
facility: University Hip and Knee Specialists
state: New Jersey
city: Somerset
country: United States
facility: University Orthopaedic Associates, LLC
state: New Jersey
Study officials:
References: