Low Back PainNCT01918943
Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain
An observational study of Low Back Pain and Spondylolisthesis, run by American British Cowdray Medical Center at 1 site in Mexico.
Trial summary
Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Low Back Pain, Spondylolisthesis, Spondylosis
- What is being tested?
- PLIF and Aspen (spinous process fixation device)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2012to Aug 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 40 years and older with clinical and radiological signs of low back pain and spinal instability or degenerative disc disease requiring single level decompression and fusion.
Who may be able to join
- Oswestry Disability Index score >30%
- Diagnosis of low back pain and/or radicular pain associated to spinal instability
- Diagnosis of low back pain and/or radicular pain associated to degenerative disc disease
- Elective single level surgery
- Signed informed consent form
Who cannot join
- Previous surgery with complete laminectomy, pars defect, etc
- Patients that during the surgery requires complete laminectomy at level of the surgery
- Structural lesion to facet joints
- Osteoporosis
- Systemic or local infection
- Pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
American British Cowdray Medical Center
Mexico City, Mexico DF, 05300
Ernesto E Galvan Hernandez, MD, MsC, 16647205 ext. 4155, egalh@yahoo.com
Ernesto E Galvan Hernandez, MD, MsC
About this study
Official title: Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain in the Presence of Lumbar Instability and Degenerative Disk Disease
Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis.
Many techniques evolved since then, from wiring, rods, pedicle screws, and recently inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior fusion techniques, two methods of achieving an interbody fusion from a posterior approach have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more common technique, requiring in some cases, complemental posterior fixation with pedicle screws, facet screws or interspinous fixation devices like the Aspen device.
In this study, we address the clinical and radiological outcome of a novel technique using standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar approach.
- Being tested
- PLIF and Aspen (spinous process fixation device)
- Keywords
- Spine, Aspen device, PLIF, Low back pain
- Medical subject headings
- Low Back Pain, Spondylolisthesis, Spondylosis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLIF and Aspen (spinous process fixation device)Device
Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device
| Study group | Role | What they receive |
|---|---|---|
| PLIF and Aspen device patients | All patients will receive PLIF and Aspen device Receives: Device: PLIF and Aspen (spinous process fixation device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index Score Change
Change between Oswestry Disability Index between pre-operative and final 12 months socores
Measured: 12 months
Secondary outcomes (3)
Rolland Morris Score
Change in score in the Rolland Morris Score (RMS)
Measured: 12 months
Visual Analogue Scale
Change in pain measured by the visual analogue scale
Measured: 12 months
Bone fusion (arthrodesis)
Adequate bone fusion measured by computed tomography (CT) scan
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American British Cowdray Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galvan Ernesto Eduardo, American British Cowdray Medical Center
- Investigators
- Roberto De Leo Vargas, MD, Study director, Centro Medico ABCMaximino Tellez, MD, Study chair, Centro Medico ABCRodrigo Navarro, MD, Study chair, Centro Medico ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918943
- Sponsor's protocol ID
- ABC-Aspen-2013
- Status last verified
- Aug 2013
- First submitted
- 6 Aug 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain in the Presence of Lumbar Instability and Degenerative Disk Disease
- ClinicalTrials.gov ID
- NCT01918943
- Acronym / sponsor ID
- ABC-Aspen-2013
- Keywords
- Spine, Aspen device, PLIF, Low back pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- American British Cowdray Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 8 Aug 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.
Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis.
Many techniques evolved since then, from wiring, rods, pedicle screws, and recently inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior fusion techniques, two methods of achieving an interbody fusion from a posterior approach have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more common technique, requiring in some cases, complemental posterior fixation with pedicle screws, facet screws or interspinous fixation devices like the Aspen device.
In this study, we address the clinical and radiological outcome of a novel technique using standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLIF and Aspen device patients | – | Device: PLIF and Aspen (spinous process fixation device)All patients will receive PLIF and Aspen device |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 40 years and older with clinical and radiological signs of low back pain and spinal instability or degenerative disc disease requiring single level decompression and fusion.
Key inclusion criteria (5 listed)
- Oswestry Disability Index score >30%
- Diagnosis of low back pain and/or radicular pain associated to spinal instability
- Diagnosis of low back pain and/or radicular pain associated to degenerative disc disease
- Elective single level surgery
- Signed informed consent form
Key exclusion criteria (6 listed)
- Previous surgery with complete laminectomy, pars defect, etc
- Patients that during the surgery requires complete laminectomy at level of the surgery
- Structural lesion to facet joints
- Osteoporosis
- Systemic or local infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLIF and Aspen (spinous process fixation device)Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device | Device | PLIF and Aspen device patients |
Primary outcome
Oswestry Disability Index Score Change
Time frame: 12 months
Change between Oswestry Disability Index between pre-operative and final 12 months socores
3 secondary outcomes
Rolland Morris Score
Time frame: 12 months
Visual Analogue Scale
Time frame: 12 months
Bone fusion (arthrodesis)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
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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.
Roberto De Leo Vargas, MD study director
Centro Medico ABC
Maximino Tellez, MD study chair
Centro Medico ABC
Rodrigo Navarro, MD study chair
Centro Medico ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Spondylolisthesis, run by American British Cowdray Medical Center at 1 site in Mexico.
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 5 inclusion and 6 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 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Contact Eduardo Galvan, MD (52(55)16647205, egalh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index Score Change (time frame: 12 months). 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 8 Aug 2013.