Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/1/2014 |
| Start Date: | June 2013 |
| End Date: | December 2013 |
| Contact: | Rebecca Gibson |
| Email: | rebecca.gibson@baxsurg.com |
| Phone: | 1.877.493.1570 |
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.
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.
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.
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials