|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060018 / PAS002 |
| Date Original Protocol Accepted |
07/16/2007
|
| Date Current Protocol Accepted |
07/16/2007
|
| Study Name |
Enhanced Surveillance
|
| Device Name |
PRESTIGE CERVICAL DISC SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Enhanced Surveillance
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is an enhanced surveillance system to collect the patietns demographic, clinical and device information for all complaints and adverse events (both MDR and non-MDR) possibly related to the PRESTIGE device up to 5 years after device approval
|
| Study Population |
Study includes all patients who received Prestige Cervical Disc after device approval as per device indication. This device is indicated indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e.g., pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (e.g., CT, MRI, x-rays, etc.): 1) herniated disc, and/or 2) osteophyte formation. The PRESTIGE 9 device is implanted via an open anterior approach.
|
| Sample Size |
N/A
|
| Key Study Endpoints |
Complaints and Adverse events
|
| Follow-up Visits and Length of Follow-up |
up to 5-year after device approval
|
| Interim or Final Data Summary |
| Interim Results |
During the period of December 11, 2008 through June 15, 2009, the Sponsor has received 8 complaints related to the device and 5 resulted in the filing of MDRs.
|
| Actual Number of Patients Enrolled |
n/a
|
| Actual Number of Sites Enrolled |
n/a
|
| Patient Follow-up Rate |
n/a
|
| Final Safety Findings |
Since the PMA approval date of July 16, 2007 through May 13, 2012, a cumulative total of implants have been sold in the U.S., a cumulative total of MDRs have been reported for implants sold in the U.S., and a cumulative total of MDRs have been reported for instruments sold in the U.S.
A Kaplan-Meier analysis was conducted on adverse events and second surgeries reported from PMA approval on July 16, 2007 through May 13, 2012. events were included in the time-to-adverse event analysis, with cumulative event rates of 0.413% at months, 0.479% months, 0.479% months, and 0.598%. events were included in the time-to-second surgery analysis, with cumulative event rates of 0.124% at months, 0.190% at months, 0.190% at months, and 0.309% at months and beyond following surgery
|
| Final Effect Findings |
n/a
|
| Study Strengths & Weaknesses |
The study duration was for 5 years after PMA approval, allowing time to monitor adverse events and complaints received by the company for the device in the postmarket setting.
There may be under-reporting of adverse events and complaints to the company. Therefore, the true number of adverse events and complaints during the 5-year study period is unknown.
In addition, the total number of implants sold may be an overestimate of the number of devices actually implanted. Therefore, the true number of devices implanted during the 5-year study period is unknown.
|
| Recommendations for Labeling Changes |
A labeling change based on the results from this study is not recommended because the study was designed as a surveillance study.
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