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

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 Overview

• Status: Completed
• Conditions: Degenerative Disc Disease

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Memorial Orthopaedic Surgical Group
    • Santa Ana, California, United States, 92705
      • Minimally Invasive Neurosurgery
  • New York
    • Great Neck, New York, United States, 11021
      • NorthShore LIJ
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Advanced Spine & Pain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 40 subjects will be enrolled across the participating sites; 20 subjects who have been treated with the VEO® lateral system and 20 who have been treated with the XLIF® system. Consecutive subjects at the participating sites that meet all of the inclusion criteria and none of the exclusion criteria will be eligible for study participation until the enrollment target is reached.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
VEO® Lateral Access and Interbody Fusion System
eXtreme Lumbar Interbody Fusion (XLIF®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Observed for up to 6 months post-surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baxano Surgical, Inc.
• Investigators: Principal Investigator: Philip Yuan, MD, Memorial Orthopaedic Surgical Group

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Estimate): August 12, 2014
• Last Update Submitted That Met QC Criteria: August 11, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: PR-0025 (Other Identifier: TranS1)