Degenerative Disc DiseaseNCT01878149
Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects
An observational study of Degenerative Disc Disease, run by Baxano Surgical, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease
- How many people
- 34 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2013to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Advanced Spine & Pain
Arlington, Virginia, 22205
NorthShore LIJ
Great Neck, New York, 11021
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806
Minimally Invasive Neurosurgery
Santa Ana, California, 92705
About this study
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
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VEO® Lateral Access and Interbody Fusion System | Not described | |
| eXtreme Lumbar Interbody Fusion (XLIF®) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Observed for up to 6 months post-surgery
Secondary outcomes (1)
Safety
Incidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness.
Measured: Observed for up to 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxano Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Yuan, MD, Principal investigator, Memorial Orthopaedic Surgical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878149
- Sponsor's protocol ID
- PR-0025
- Other IDs
- PR-0025
- Status last verified
- Aug 2014
- First submitted
- 11 Jun 2013
- Last updated
- 12 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01878149
- Acronym / sponsor ID
- PR-0025
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Baxano Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Posted 12 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VEO® Lateral Access and Interbody Fusion System | – | – |
| eXtreme Lumbar Interbody Fusion (XLIF®) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures
Time frame: 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.
1 secondary outcome
Safety
Time frame: Observed for up to 6 months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Yuan, MD principal investigator
Memorial Orthopaedic Surgical Group
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Baxano Surgical, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures (time frame: Observed for up to 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.