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General |
Study Status |
Completed |
Application Number / Requirement Number |
P110009 / PAS002 |
Date Original Protocol Accepted |
08/23/2013
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Date Current Protocol Accepted |
05/19/2014
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Study Name |
Enhanced Surveillance System
|
Device Name |
MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
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Clinical Trial Number(s) |
NCT00389597
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General Study Protocol Parameters |
Study Design |
Enhanced Surveillance
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
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Detailed Study Protocol Parameters |
Study Objectives |
A 10-year Enhanced Surveillance Study (ESS) of the Mobi-C® Cervical Disc Prosthesis to fully characterize adverse events and complaints when the device is used in the intended patient population under general conditions of use in the United States and in the rest of the world. The objective is to collect, analyze, and submit all adverse event data.
|
Study Population |
All patients who are implanted with the device The data on AEs will be collected by the company and reported to the FDA: 1. Through literature search (every 6 months for first 2 years and then annually thereafter) 2. AEs reported through company website 3. MDR reports 4. Annual survey of all USA physicians who were trained with the device
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Sample Size |
N/A
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Key Study Endpoints |
All adverse Events will be reported including HO, neurological complications, subsequent surgeries and etc. The data will be categorized based on severity, and device and MDR relevancy.
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Follow-up Visits and Length of Follow-up |
10 years
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
N/A There is no enrollment of patients. All patients who have received this device in the post-market environment, i.e. all patients who are implanted with the device. The intended patient population under general conditions of use in the United States and in the rest of the world.
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Actual Number of Sites Enrolled |
N/A Annual surgeon survey: active collection of surgeon feedback annually to elicit information related to heterotopic ossification, device malfunction, device removal, or other serious device related complications.
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Patient Follow-up Rate |
Numbers of sites, IRB approvals and study participants are not available, since this ESS does not include enrollment of sites/patients. There is no enrollment of patients.
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Final Safety Findings |
Not evaluated, this is a surveillance study
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Final Effect Findings |
Not evaluated, this is a surveillance study
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Study Strengths & Weaknesses |
The strength of this study is that the data is collected from real world usage of this device and used by practitioners with a variety of experience and familiarity with the device. The weakness is that this study is highly dependent on surgeon feedback, so the response rate may be low.
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Recommendations for Labeling Changes |
N/A Labeling was updated with 7-year follow-up data and no new issues or concerns have been found since that time
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