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: Degenerative Disc Disease

• Registration Number: NCT01878149
• Lead Sponsor: Baxano Surgical, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-14
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2014-05-30
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-11
• Last Update Submitted: 2014-08-11
• Results First Posted: 2014-08-12
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures	Observed for up to 6 months post-surgery	Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.

Secondary Outcome Measures

Name	Time	Method
Safety	Observed for up to 6 months post-surgery	Incidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness.

Trial Locations

Locations (4)

NorthShore LIJ; 🇺🇸 Great Neck, New York, United States

Advanced Spine & Pain; 🇺🇸 Arlington, Virginia, United States

Memorial Orthopaedic Surgical Group; 🇺🇸 Long Beach, California, United States

Minimally Invasive Neurosurgery; 🇺🇸 Santa Ana, California, United States