Spinal StenosisNCT02171169
Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
An observational study of Spinal Stenosis and Spondylolisthesis, run by Baxano Surgical, Inc. at 3 sites in United States.
Trial summary
The purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Subject candidates are those that have been treated with either the transsacral or transforaminal lumbar interbody fusion procedure at least one year prior to this evaluation.
Who may be able to join
- Adult aged 18 years or older
- Male or Female subject that had previously received transsacral single-level procedure when used in conjunction with bilateral pedicle screw fixation or TLIF single-level procedure with bilateral supplemental screw fixation (e.g. pedicle screws, anterior devices with screw anchoring, anterior lumber plates) as an adjunct to fusion at L5-S1 to treat spinal stenosis, spondylolithesis or degenerative disc disease (DDD)
- Subject that was treated no less than 1 year (-2 months) prior to this evaluation with a transsacral or TLIF procedure by participating surgeons
Who cannot join
- Subject had history of previous back operations at the time of the index procedure
- Subject had extraspinal cause of back pain or sciatica at the time of the index procedure
- Severe scoliosis in the lumbar region
- Subject was or is currently involved in active litigation
- Subject that had a diagnosis and received a transsacral or TLIF procedure at L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
St. Joseph Heritage Healthcare
Fullerton, California, 92835
Michigan Spine Institute
Waterford, Michigan, 48328
About this study
The purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and comply with US regulations and requirements.
Read the detailed description
Study Objective:
The study objective is to demonstrate via retrospective data review the relative value of two lumbar fusion procedures: transsacral lumbar interbody fusion and the transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Subject candidates are those who had required fusion at L5-S1 where this was the only lumbar level treated for spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Consecutive subjects who were treated with the transsacral lumbar interbody fusion or transforaminal lumbar interbody fusion procedure at least 1 year (- 2 months) prior to the date the data is collected will be evaluated.
Study Design, Endpoints:
Primary Endpoint:
Safety: Incidence of reported adverse events, including those requiring medical intervention, by 3 months post-operative.
Secondary Endpoints:
Health Economic: Operative measures, including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge, as applicable.
Health Economic: Comparative hospital data (from time of admission through time of discharge)
Clinical Effectiveness: A decrease in back pain compared to baseline at 3 months (+/-2 weeks) as measured by Visual Analog Scale (VAS).
Clinical Effectiveness: A decrease in disability compared to baseline at 3 months (+/-2 weeks) as measured by the Oswestry Disability Index (ODI).
Study Design, Enrollment:
Approximately 200 subjects will be enrolled in this study, 100 subjects who have been treated with transsacral lumbar interbody fusion and 100 subjects who have been treated with transforaminal lumbar interbody fusion.
Study Design, Analyses:
The retrospective clinical evaluation will collect and compare results for the procedure transsacral lumbar interbody fusion versus transforaminal lumbar interbody fusion as defined by the primary and secondary endpoints.
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis, 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 |
|---|---|---|
| Transsacral lumbar interbody fusion | Not described | |
| Transforaminal lumbar interbody fusion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Incidence of reported adverse events, including those requiring medical intervention.
Measured: 3 months post-operative
Secondary outcomes (2)
Health Economic
Operative measures including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge.
Comparative hospital data
Measured: Up to 3 months post-operative
Clinical Effectiveness
A decrease in back pain compared to baseline at 3 months as measured by Visual Analog Scale A decrease in disability compared to baseline at 3 months as measure by the Oswestry Disability Index
Measured: 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baxano Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Whang, MD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171169
- Sponsor's protocol ID
- PR-07875
- Status last verified
- Sep 2014
- First submitted
- 19 Jun 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
- ClinicalTrials.gov ID
- NCT02171169
- Acronym / sponsor ID
- PR-07875
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Baxano Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
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 data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and comply with US regulations and requirements.
Detailed description
Study Objective:
The study objective is to demonstrate via retrospective data review the relative value of two lumbar fusion procedures: transsacral lumbar interbody fusion and the transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Subject candidates are those who had required fusion at L5-S1 where this was the only lumbar level treated for spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Consecutive subjects who were treated with the transsacral lumbar interbody fusion or transforaminal lumbar interbody fusion procedure at least 1 year (- 2 months) prior to the date the data is collected will be evaluated.
Study Design, Endpoints:
Primary Endpoint:
Safety: Incidence of reported adverse events, including those requiring medical intervention, by 3 months post-operative.
Secondary Endpoints:
Health Economic: Operative measures, including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge, as applicable.
Health Economic: Comparative hospital data (from time of admission through time of discharge)
Clinical Effectiveness: A decrease in back pain compared to baseline at 3 months (+/-2 weeks) as measured by Visual Analog Scale (VAS).
Clinical Effectiveness: A decrease in disability compared to baseline at 3 months (+/-2 weeks) as measured by the Oswestry Disability Index (ODI).
Study Design, Enrollment:
Approximately 200 subjects will be enrolled in this study, 100 subjects who have been treated with transsacral lumbar interbody fusion and 100 subjects who have been treated with transforaminal lumbar interbody fusion.
Study Design, Analyses:
The retrospective clinical evaluation will collect and compare results for the procedure transsacral lumbar interbody fusion versus transforaminal lumbar interbody fusion as defined by the primary and secondary endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transsacral lumbar interbody fusion | – | – |
| Transforaminal lumbar interbody fusion | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject candidates are those that have been treated with either the transsacral or transforaminal lumbar interbody fusion procedure at least one year prior to this evaluation.
Key inclusion criteria (3 listed)
- Adult aged 18 years or older
- Male or Female subject that had previously received transsacral single-level procedure when used in conjunction with bilateral pedicle screw fixation or TLIF single-level procedure with bilateral supplemental screw fixation (e.g. pedicle screws, anterior devices with screw anchoring, anterior lumber plates) as an adjunct to fusion at L5-S1 to treat spinal stenosis, spondylolithesis or degenerative disc disease (DDD)
- Subject that was treated no less than 1 year (-2 months) prior to this evaluation with a transsacral or TLIF procedure by participating surgeons
Key exclusion criteria (5 listed)
- Subject had history of previous back operations at the time of the index procedure
- Subject had extraspinal cause of back pain or sciatica at the time of the index procedure
- Severe scoliosis in the lumbar region
- Subject was or is currently involved in active litigation
- Subject that had a diagnosis and received a transsacral or TLIF procedure at L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery.
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
Time frame: 3 months post-operative
Incidence of reported adverse events, including those requiring medical intervention.
2 secondary outcomes
Health Economic
Time frame: Up to 3 months post-operative
Clinical Effectiveness
Time frame: 3 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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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.
Peter Whang, MD study director
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis and Spondylolisthesis, run by Baxano Surgical, Inc. at 3 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 5 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: status not confirmed, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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 (time frame: 3 months post-operative). 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 3 Sep 2014.