Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain
NCT ID: NCT01918943
Last Updated: 2013-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2012-08-31
2015-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PLIF and Aspen device patients
All patients will receive PLIF and Aspen device
PLIF and Aspen (spinous process fixation device)
Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device
Interventions
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PLIF and Aspen (spinous process fixation device)
Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
70 Years
ALL
No
Sponsors
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American British Cowdray Medical Center
OTHER
Responsible Party
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Galvan Ernesto Eduardo
MD
Principal Investigators
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Roberto De Leo Vargas, MD
Role: STUDY_DIRECTOR
Centro Medico ABC
Maximino Tellez, MD
Role: STUDY_CHAIR
Centro Medico ABC
Rodrigo Navarro, MD
Role: STUDY_CHAIR
Centro Medico ABC
Locations
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American British Cowdray Medical Center
Mexico City, Mexico DF, Mexico
Countries
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Central Contacts
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Facility Contacts
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Ernesto E Galvan Hernandez, MD, MsC
Role: primary
Other Identifiers
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ABC-Aspen-2013
Identifier Type: -
Identifier Source: org_study_id