Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT01343693
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MaxAn Post Market Surveillance Validation
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MaxAn
Brief Summary:
This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years.
Detailed Description:
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the MaxAn® Anterior Cervical Plate System. Dr. Park, et.al conducted a retrospective review and found a positive association between adjacent-level ossification following anterior cervical plate procedures and the plate-to-disc distance. 1 They concluded that when the anterior cervical plates were placed at least 5mm away from the adjacent disc spaces, there was a decrease in the likelihood of moderate-to-severe adjacent-level ossification. The design of the MaxAn Anterior Cervical Plate and accompanying technique allows this type of plate placement; therefore we will be looking at the radiographic outcomes of these subjects and comparing them to the retrospective chart review conducted by Dr. Park using the MaxAn Technique allows you to achieve plate placement of 5mm from the supraadjacent level which will help minimize the risk of adjacent level ossification.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: