NCT01343693

MaxAn Post Market Surveillance Validation

A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 119 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• DDD
• Deformity
• Tumor
• Fracture

Timeline

• Start date: 2011-06-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2011-04-28
• Last updated: 2020-01-06
• Results posted: 2020-01-06

Locations

6 sites across 1 country: United States