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

Completed

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT01878149

Run by

Baxano Surgical, Inc.

People needed

34

Starts

2013-06-01

Expected to finish

2014-03-01

Last updated by the study team

2014-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult 18 years of age or older;
• Male or female VEO® subjects that had previously received the single or two level LLIF procedure using the VEO® or XLIF® systems as an adjunct to fusion at L2-S1 to treat degenerative disc disease (DDD) at the treated level;
• Subject that was treated no less than 3 months prior to this evaluation with the LLIF procedure using the VEO® or XLIF® system by the participating surgeons.

You may not qualify if…

• Subject who did not receive LLIF procedure using the VEO® or XLIF® system for fusion of L2-S1;
• Subjects with less than 3 months of follow-up data.

Where it is running

• Memorial Orthopaedic Surgical Group — Long Beach, California, United States
• Minimally Invasive Neurosurgery — Santa Ana, California, United States
• NorthShore LIJ — Great Neck, New York, United States
• Advanced Spine & Pain — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.