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

Baxano Surgical, Inc.34 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Disc Disease

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures

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.

Time frame: Observed for up to 6 months post-surgery

Secondary Outcomes

Safety

Incidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness.

Time frame: Observed for up to 6 months post-surgery