|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
P100012 / PAS001 |
Date Original Protocol Accepted |
10/26/2012
|
Date Current Protocol Accepted |
08/25/2015
|
Study Name |
PCM Cervical Enhanced Surveillance
|
Device Name |
NUVASIVE PCM 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 |
The study design is enhanced surveillance.
|
Study Population |
Skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space.
|
Sample Size |
The sample size is comprised of all patients who receive the device after its approval. All US physicians who utilize the device will be surveyed.
|
Key Study Endpoints |
Subsequent surgeries, heterotopic ossification, and other device related adverse events
|
Follow-up Visits and Length of Follow-up |
Surgeons will be surveyed on an annual basis and for ten (10) years from the PMA approval date.
|
Interim or Final Data Summary |
Interim Results |
A total of 128 physicians were identified to survey. Of the surgeons surveyed, 8 responded. The overall response rate was 6.25% (8/128).
|
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 devicerelated 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 |
N/A
|