Clinical trial NCT01918943: Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Spondylolisthesis
Spondylosis
Spinal Instability
Spinal Stenosis
Keywords: Spine
Aspen device
PLIF
Low back pain
Lead sponsor: American British Cowdray Medical Center
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Oswestry Disability Index Score Change
timeFrame: 12 months
Secondary outcomes:
measure: Rolland Morris Score
timeFrame: 12 months
measure: Visual Analogue Scale
timeFrame: 12 months
measure: Bone fusion (arthrodesis)
timeFrame: 12 months
Other outcomes:
measure: Operative parameters
timeFrame: At surgery
Locations:
city: Mexico City
country: Mexico
facility: American British Cowdray Medical Center
state: Mexico DF
Study officials:
affiliation: Centro Medico ABC
name: Roberto De Leo Vargas, MD
role: STUDY_DIRECTOR
affiliation: Centro Medico ABC
name: Maximino Tellez, MD
role: STUDY_CHAIR
affiliation: Centro Medico ABC
name: Rodrigo Navarro, MD
role: STUDY_CHAIR
References: