Status:
UNKNOWN
Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain
Lead Sponsor:
American British Cowdray Medical Center
Conditions:
Low Back Pain
Spondylolisthesis
Eligibility:
All Genders
40-70 years
Brief 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....
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01918943
Start Date
August 1 2012
End Date
August 1 2015
Last Update
August 8 2013
Active Locations (1)
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1
American British Cowdray Medical Center
Mexico City, Mexico DF, Mexico, 05300