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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070001 / PAS002 |
| Date Original Protocol Accepted |
08/12/2008
|
| Date Current Protocol Accepted |
08/12/2008
|
| Study Name |
Enhanced Surveillance Study
|
| Device Name |
PRODISC TM-C TOTAL DISC REPLACEMENT
|
| 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 Pro-Disc device up to 5 years after device approval
|
| Study Population |
Study population is as per device approval. The study includes all patients who received Prodisc after device approval. This device is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a ftmctional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The ProDiscTM-C Total Disc Replacement is implanted via an open anterior approach. Patients receiving the ProDiscTM-C Total Disc Replacement should have failed at least six weeks of non-operative treatment prior to implantation of the ProDiscTM-C Total Disc Replacement.
|
| 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 |
From the December 17, 2007 approval of the ProDisc-C device, through December 7, 2009, Synthes has received a total of 65 complaints for this device. Fifteen complaints are currently being investigated internally and additional information will be provided to the agency as it becomes available. Forty-three of the complaints were determined to be MDR reportable. Eight complaints were determined as "non-valid".
|
| Actual Number of Patients Enrolled |
Not applicable this is Enhanced surveillance investigation
|
| Actual Number of Sites Enrolled |
Not applicable this is Enhanced surveillance investigation
|
| Patient Follow-up Rate |
Not applicable this is Enhanced surveillance investigation
|
| Final Safety Findings |
Since the PMA approval of December 17, 2007 through November 1, 2012,
theinformation on the cumulative total MDRs (n=214) and device sales has been collected and evaluated. During 60-monthds of the study period, no
unanticipated adverse events were identified, and the device has not been withdrawn from any of the markets.
|
| Final Effect Findings |
Not applicable this is Enhanced surveillance investigation
|
| Study Strengths & Weaknesses |
The duration of the Enhanced Surveillance System was 5 years after PMA approval, allowing time to monitor longer term adverse events and complaints received by the company for the device in the post-market 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.
|
| Recommendations for Labeling Changes |
No labeling change is recommended because the adverse events noted in the final report are not unanticipated.
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