Study Stopped
There is no regulatory or otherwise commitment to continue to follow up to the 10-year time point. The study data had met the primary objectives. After a business review, Smith+Nephew had decided to terminate the study prematurely.
LEGION™ Primary Safety and Efficacy
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
1 other identifier
interventional
128
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2009
CompletedFirst Submitted
Initial submission to the registry
July 18, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2020
CompletedResults Posted
Study results publicly available
October 10, 2024
CompletedOctober 10, 2024
January 1, 2024
11.3 years
July 18, 2019
January 12, 2024
July 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implant Survivorship Percentage
Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months
Postoperatively through 120 months
Secondary Outcomes (10)
Knee Society Score (KSS) - Performance
Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Society Score (KSS) - Function
Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Osteoarthritis Outcome Score (KOOS) - Pain
Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Osteoarthritis Outcome Score (KOOS) - Symptom
Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL)
Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months
- +5 more secondary outcomes
Study Arms (1)
LEGION™ Primary
OTHERLEGION™ Primary Total Knee Arthroplasty (TKA)
Interventions
Primary Total Knee Arthroscopy using LEGION™ Total Knee System
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Orthopaedic Associates of Vero Beach
Vero Beach, Florida, 32960, United States
Iowa Orthopaedic Center
Des Moines, Iowa, 50314, United States
Louisville Bone & Joint Specialist, PSC
Louisville, Kentucky, 40207, United States
University Hip and Knee Specialists
Monroe, New Jersey, 08831, United States
University Orthopaedic Associates, LLC
Somerset, New Jersey, 08873, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations of study included high drop-out rate, which was additionally influenced by impact COVID-19 had on subject retention \& follow-up rate. Participants lost to follow-up based on presumed loss of power at the 7-year (62.7% follow-up rate) \& 10-year (58.5%) time points led to early study termination by Sponsor.
Results Point of Contact
- Title
- Michael Howarth
- Organization
- Smith and Nephew
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2019
First Posted
August 1, 2019
Study Start
September 9, 2009
Primary Completion
December 17, 2020
Study Completion
December 17, 2020
Last Updated
October 10, 2024
Results First Posted
October 10, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share