|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P090029 / PAS001 |
| Date Original Protocol Accepted |
07/24/2014
|
| Date Current Protocol Accepted |
07/24/2014
|
| Study Name |
Extended Follow-Up
|
| Device Name |
PRESTIGE LP CERVICAL DISC
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
280 subjects in the Investigational (INV) cohort, 30 in the Metal Ion cohort, and 24 in the Continued Access cohort.
|
| Actual Number of Sites Enrolled |
20 clinical sites have received IRB approval, 15 of them have been enrolled.
|
| Patient Follow-up Rate |
INV follow-up rate was reported as 82.2% and 90.9% for 84 months (± 3 months) and 120 months (± 6 months), respectively.
|
| Final Safety Findings |
No alarming safety trends were identified. However, there is a need to further address higher cumulative rate for vascular adverse events in INV group vs. controls and explore its possible reasons other than by a chance finding.
|
| Final Effect Findings |
Bayesian analyses showed a posterior probability of non- inferiority of essentially 100.0% and a posterior probability of superiority of 98.5% for overall success without Functional Spine Unit (FSU) and a posterior probability of non-inferiority of 94.5% with FSU. Both non-inferiority and superiority of the Prestige lp disc over the control treatment were established for overall success without FSU. Non-inferiority of the Prestige lp disc was missed by 0.5% for overall success with FSU (based on the success criteria of posterior probability of 95%) due to the low rate of the FSU success in the Prestige lp disc group vs. control (83.8% vs. 96.9%, respectively). Angular motion among subjects with the Prestige lp disc was higher at superior, but not inferior, adjacent level.
|
| Study Strengths & Weaknesses |
This Extended Follow-up study successfully demonstrated non- inferiority of overall Prestige LP disk performance compared to comparator. However, longer-term device performance needs further evaluation, especially taking into account that this follow-up study was based on historical control and therefore lacked comparator data beyond the 84-month timepoint.
|
| Recommendations for Labeling Changes |
Labeling changes were recommended to reflect that FSU non- inferiority in the INV group was missed at the 84 months as well as refer to some other study findings such as higher cumulative rate for vascular adverse events in the INV group.
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