Clinical trial NCT01878149: Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Baxano Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures
timeFrame: Observed for up to 6 months post-surgery
Secondary outcomes:
measure: Safety
timeFrame: Observed for up to 6 months post-surgery
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Memorial Orthopaedic Surgical Group
state: California
city: Santa Ana
country: United States
facility: Minimally Invasive Neurosurgery
state: California
city: Great Neck
country: United States
facility: NorthShore LIJ
state: New York
city: Arlington
country: United States
facility: Advanced Spine & Pain
state: Virginia
Study officials:
affiliation: Memorial Orthopaedic Surgical Group
name: Philip Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References: