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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878149
• Other study ID #: PR-0025
• Secondary ID: PR-0025
• Status: Completed
• Phase: N/A
• First received: June 11, 2013
• Last updated: August 11, 2014
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Baxano Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
United States	Advanced Spine & Pain	Arlington	Virginia
United States	NorthShore LIJ	Great Neck	New York
United States	Memorial Orthopaedic Surgical Group	Long Beach	California
United States	Minimally Invasive Neurosurgery	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Baxano Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No