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

NCT01878149 | Completed Results

• 1 other identifier: PR-0025
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 4

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety

  Observed for up to 6 months post-surgery

Study Arms (2)

VEO® Lateral Access and Interbody Fusion System

eXtreme Lumbar Interbody Fusion (XLIF®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Baxano Surgical, Inc.: lead

Study Sites (4)

Memorial Orthopaedic Surgical Group

Long Beach, California, 90806, United States

Location

Minimally Invasive Neurosurgery

Santa Ana, California, 92705, United States

Location

NorthShore LIJ

Great Neck, New York, 11021, United States

Location

Advanced Spine & Pain

Arlington, Virginia, 22205, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Sr. Director of Clinical Affairs
• Organization: Baxano Surgical®

teresa.schroeder@baxsurg.com

919.899.9760

Study Officials

• Philip Yuan, MD

  Memorial Orthopaedic Surgical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 14, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 12, 2014
• Results First Posted: August 12, 2014

Record last verified: 2014-08

Locations

US (4)