Degenerative Disc Disease
Conditions
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.
Interventions
None listed
Sponsors
Baxano Surgical, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures | Observed for up to 6 months post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Observed for up to 6 months post-surgery | Incidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness. |
Countries
United States
Participant flow
Recruitment details
Consecutive subjects at each site meeting all of the study eligibility criteria and who were treated with LLIF using the VEO® or XLIF® systems at least 3 months prior to the date the data is collected were included in this evaluation.
Pre-assignment details
The Sponsor originally collected data on 38 subjects, 21 subjects in the VEO treatment arm and 17 subjects in the XLIF® treatment arm, from a total of five sites. Four study subjects (two subjects from each study arm) were excluded from the final evaluation as they did not meet the inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| VEO® Lateral Access and Interbody Fusion System This study included adult men and women (\> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the VEO® spinal procedure. VEO® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD). | 19 |
| eXtreme Lumbar Interbody Fusion (XLIF®) This study included adult men and women (\> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the XLIF® spinal procedure. XLIF® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD). | 15 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did Not Meet Eligibility Criteria | 2 | 2 |
Baseline characteristics
| Characteristic | VEO® Lateral Access and Interbody Fusion System | eXtreme Lumbar Interbody Fusion (XLIF®) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 6 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Continuous | 61.63 years STANDARD_DEVIATION 13.13 | 63 years STANDARD_DEVIATION 12.35 | 62.21 years STANDARD_DEVIATION 12.36 |
| Region of Enrollment United States | 19 participants | 15 participants | 34 participants |
| Sex: Female, Male Female | 13 Participants | 4 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 11 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 21 | 7 / 17 |
| serious Total, serious adverse events | 0 / 21 | 4 / 17 |
Outcome results
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.
Time frame: Observed for up to 6 months post-surgery
Population: It was anticipated that approximately 40 subjects would be enrolled across the participating sites; 20 subjects in each treatment arm. Consecutive subjects who were treated with LLIF using the VEO® or XLIF® systems at least 3 months prior to the the data collection were included. The planned sample size was not statistically derived.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VEO® Lateral Access and Interbody Fusion System | Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures | 19 participants |
| eXtreme Lumbar Interbody Fusion (XLIF®) | Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures | 15 participants |
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.
Time frame: Observed for up to 6 months post-surgery