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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Long Term Study

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Study Status Completed
Application Number P060037 / PAS001
Date Current Protocol Accepted 11/16/2016
Study Name Long Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: to assess the long-term safety and effectiveness of the NexGen® LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease, in comparison with the LPS-Flex Fixed Bearing Knee.
Design: a prospective, multi-center, parallel group, controlled post-approval study comparing the clinical performance of the LPS-Flex Mobile Bearing Knee with the LPS-Flex Fixed Bearing Knee. The study includes both continued follow-up of premarket IDE cohorts through the 10th post-operative year and new enrollment and follow-up of patients through their 5th post- operative year.
Study Population Description Study population is as per device indication. This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis (RA), osteoarthritis (OA), primary and secondary traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle or pseudo-gout - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.- Moderate valgus, varus, or flexion deformities. Group 1 consists of patients who received either the LPS-Flex Fixed Bearing Knee
or the LPS-Flex Mobile Bearing Knee during the active IDE, completed the IDE study and have given written consent to participate in the post-approval study. Group 2 patients will be enrolled into a single-arm, historically controlled, mid-term study (5 years) and this group will consist of 100 patients who undergo Total Knee Replacement with the LPS-Flex Mobile Bearing Knee after the device approval.
Sample Size The sample size is 400 patients. Group 1 approximately 300 patients already implanted during the IDE study with either the LPS-Flex Fixed Bearing Knee (control population, N=150) or the LPS-Flex Mobile Bearing Knee device (N=150) at one of approximately 10 sites. Group 2 100 patients who are eligible for a total knee replacement, have chosen to receive the LPS-Flex Mobile Bearing Knee, and meet the PAS eligibility criteria.
Data Collection A composite clinical success, defined by the following criteria, will be used as the primary outcome: - Knee Society assessment score greater than/equal to 70 points- Knee Society function score greater than/equal to 70 points - No intended, actual, or planned removal of any component of the knee system - Absence of severe knee-related complications - An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by independent radiographic reviewer. Safety endpoints: revision, removal and device-related adverse Secondary endpoint: Quality of Life
Follow-up Visits and Length of Follow-up Group 1: 10 years post-operation
Group 2: 5 years post-operation
Group 1: Postoperatively at 4 years (if applicable), 5 years (if applicable), 6 years, 8 years and 10 years.
Group 2: Postoperatively at 6 weeks, 6 months, and at 1, 2, 3, 4 and 5 years post-operation.
The patients will be followed at 6 weeks, 6 months and at annual increments up to 5 years post-operation for Group 2/And followed at 5, 6, 8/And 10 years post-operation for Group 1.

Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Long term study 6 month report 06/09/2008 05/22/2008 On Time
Long term study 1 year report 12/09/2008 11/26/2008 On Time
Long term study 18 month report 06/09/2009 06/03/2009 On Time
Long term study 2 year report 12/09/2009 12/09/2009 On Time
Long term study 3 year report 12/09/2010 12/08/2010 On Time
Long term study 4 year report 12/09/2011 12/06/2011 On Time
Long term study 5 year report 12/08/2012 12/05/2012 On Time
Long term study 6 year report 12/08/2013 12/06/2013 On Time
Long term study 7 year report 12/20/2014 12/22/2014 Overdue/Received
Unscheduled Report 08/31/2015 08/31/2015 On Time
Long term study 8 and 9 year report 12/07/2016 12/02/2016 On Time
Long term study 10 year report 12/07/2017 11/30/2017 On Time
11 year report 12/07/2018 12/06/2018 On Time
12 year report 12/07/2019 12/06/2019 On Time
final Report 11/23/2020 11/23/2020 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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