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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P110009 / PAS002 |
| Date Original Protocol Accepted |
08/23/2013
|
| Date Current Protocol Accepted |
05/19/2014
|
| Study Name |
Enhanced Surveillance System
|
| Device Name |
MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
|
| General Study Protocol Parameters |
| Study Design |
Enhanced Surveillance
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| 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
|
| Sample Size |
N/A
|
| 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.
|
| Follow-up Visits and Length of Follow-up |
10 years
|
| Interim or Final Data Summary |
| Interim Results |
A total of 3,197 physicians were identified to survey. Of the surgeons surveyed, 155 responded. In cases where a surgeon provided feedback on multiple patients in a single response, these were separated as separate cases. The overall response rate was 5% (155/3,197), which is egal from the 2022 (prior year) response rate of 5% (154/3.083), and down from 7.2% (209/2,904) in the 2021.
|
| 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.
|
| 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.
|
| 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.
|
| 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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