An observational study in Degenerative Disc Disease, sponsored by Baxano Surgical, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-12.
Sponsored by Baxano Surgical, Inc. · Observational
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.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's enrollment of 34 is below the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Baxano Surgical, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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
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
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.
| Milestone | VEO® Lateral Access and Interbody Fusion System | eXtreme Lumbar Interbody Fusion (XLIF®) |
|---|---|---|
| Started | 21 | 17 |
| Completed | 19 | 15 |
| Not completed | 2 | 2 |
| Withdrew: Did not meet eligibility criteria | 2 | 2 |
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.
| participants | VEO® Lateral Access and Interbody Fusion System | eXtreme Lumbar Interbody Fusion (XLIF®) |
|---|---|---|
| Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures | 19 | 15 |
Incidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VEO® Lateral Access and Interbody Fusion System | — | 0/21 (0%) | 8/21 (38.1%) |
| eXtreme Lumbar Interbody Fusion (XLIF®) | — | 4/17 (23.5%) | 7/17 (41.2%) |
| Event | VEO® Lateral Access and Interbody Fusion System | eXtreme Lumbar Interbody Fusion (XLIF®) |
|---|---|---|
| Deep venous thrombosis and GI prophylaxisBlood and lymphatic system disorders | 0/21 | 1/17 |
| Renal vein nickedBlood and lymphatic system disorders | 0/21 | 1/17 |
| Respiratory failure on a ventilatorRespiratory, thoracic and mediastinal disorders | 0/21 | 1/17 |
| Severe BleedingBlood and lymphatic system disorders | 0/21 | 1/17 |
| Event | VEO® Lateral Access and Interbody Fusion System | eXtreme Lumbar Interbody Fusion (XLIF®) |
|---|---|---|
| Lower extremity numbnessNervous system disorders | 5/21 | 3/17 |
| Back PainMusculoskeletal and connective tissue disorders | 5/21 | 1/17 |
| Lower extremity painNervous system disorders | 3/21 | 4/17 |
| Lower extremity weaknessNervous system disorders | 3/21 | 1/17 |
| Wound infectionSurgical and medical procedures | 0/21 | 2/17 |
| Decreased strengthNervous system disorders | 0/21 | 1/17 |
| ParasthesiaNervous system disorders | 0/21 | 1/17 |
| Incisional PainSurgical and medical procedures | 0/21 | 1/17 |
| Limited flexion/extension at waistMusculoskeletal and connective tissue disorders | 0/21 | 1/17 |
| Severe bleedingSurgical and medical procedures | 0/21 | 1/17 |
Given the nature of this retrospective evaluation, the sample size was not statistically derived but was instead intended to be representative of the body of evidence that exist for real world usage of the VEO® device.
| Age, Continuous(years) | VEO® Lateral Access and Interbody Fusion System | eXtreme Lumbar Interbody Fusion (XLIF®) | Total |
|---|---|---|---|
| Mean | 61.63 ± 13.13 | 63 ± 12.35 | 62.21 ± 12.36 |
| Age, Categorical(Participants) | VEO® Lateral Access and Interbody Fusion System | eXtreme Lumbar Interbody Fusion (XLIF®) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 9 | 18 |
| >=65 years | 10 | 6 | 16 |
| Sex: Female, Male(Participants) | VEO® Lateral Access and Interbody Fusion System | eXtreme Lumbar Interbody Fusion (XLIF®) | Total |
|---|---|---|---|
| Female | 13 | 4 | 17 |
| Male | 6 | 11 | 17 |
| Region of Enrollment(participants) | VEO® Lateral Access and Interbody Fusion System | eXtreme Lumbar Interbody Fusion (XLIF®) | Total |
|---|---|---|---|
| United States | 19 | 15 | 34 |
The record gives a start of Jun 2013, a primary completion of Mar 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →
Baxano Surgical, Inc.