PseudoarthrosisNCT01972256
A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
An observational study of Pseudoarthrosis and Spinal Stenosis, run by Baxano Surgical, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (TLIF) when used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudoarthrosis, Spinal Stenosis, Spondylolisthesis
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2013to Feb 2014
- 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 who had required fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Who may be able to join
- Adult 18 years of age or older
- Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD)
- Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons
- Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery
Who cannot join
- Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1
- Subject who received lumbar fusion procedures at levels other than L4-L5-S1 at the time of surgery
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, 70808
Brazos Spine
College Station, Texas, 77845
Indiana Spine Group
Indianapolis, Indiana, 46032
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33637
Michigan Spine Institute
Waterford, Michigan, 48327
About this study
Official title: Prospective Multicenter Clinical Evaluation of Fusion
The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or bilateral supplemental screw fixation as an adjunct to fusion.
Subject candidates are those who had previously required and received fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Read the detailed description
Consecutive subjects who were treated with the transsacral lumbar interbody fusion or TLIF procedures at least 2 years prior to the date the data is collected will be evaluated.
- Medical subject headings
- Pseudarthrosis, 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 |
|---|---|---|
| Previous transsacral fusion | Subject candidates are those who had required a transsacral fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD). | |
| Previous transforaminal lumbar interbody fusion | Subject candidates are those who had required transforaminal lumbar interbody fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Fusion of the targeted vertebral bodies (L4-L5-S1) at 24 months as determined by independent orthopedic surgeon reviewer interpretation of high resolution Computed Tomography (CT) scan.
Measured: Assessed at 2 years post-op or greater
Secondary outcomes (1)
Safety
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: 2 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudoarthrosisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baxano Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972256
- Sponsor's protocol ID
- PR-0023
- Status last verified
- Jun 2014
- First submitted
- 24 Oct 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Clinical Evaluation of Fusion
- ClinicalTrials.gov ID
- NCT01972256
- Acronym / sponsor ID
- PR-0023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Baxano Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Oct 2013 (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 study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or bilateral supplemental screw fixation as an adjunct to fusion.
Subject candidates are those who had previously required and received fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Detailed description
Consecutive subjects who were treated with the transsacral lumbar interbody fusion or TLIF procedures at least 2 years prior to the date the data is collected will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previous transsacral fusion | – | –Subject candidates are those who had required a transsacral fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD). |
| Previous transforaminal lumbar interbody fusion | – | –Subject candidates are those who had required transforaminal lumbar interbody fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD). |
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 who had required fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Key inclusion criteria (4 listed)
- Adult 18 years of age or older
- Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD)
- Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons
- Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery
Key exclusion criteria (2 listed)
- Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1
- Subject who received lumbar fusion procedures at levels other than L4-L5-S1 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
Efficacy
Time frame: Assessed at 2 years post-op or greater
Fusion of the targeted vertebral bodies (L4-L5-S1) at 24 months as determined by independent orthopedic surgeon reviewer interpretation of high resolution Computed Tomography (CT) scan.
1 secondary outcome
Safety
Time frame: 2 years post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoarthrosis and Spinal Stenosis, run by Baxano Surgical, Inc. at 5 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 4 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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy (time frame: Assessed at 2 years post-op or greater). 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 4 Jun 2014.