NCT01878149

Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Baxano Surgical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel results to XLIF® single or multilevel results relative to the safety endpoints. This study will collect retrospective data on subjects who were treated with VEO® and XLIF® at least 3 months prior to the initiation of this study. Given that fusion generally takes at least 6 months to determine, the aim of this study is not to determine fusion but to consider the short-term (out to 6 months) reported adverse events between the two cohorts. Devices used in both systems are cleared for use and conform to US regulatory requirements. The study employs these procedures and devices for uses that are consistent with their 510(k), legally cleared, labeling.

Conditions

• Degenerative Disc Disease

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-06-14
• Last updated: 2014-08-12
• Results posted: 2014-08-12

Locations

4 sites across 1 country: United States