Low Back Pain, Spinal Instability, Spinal Stenosis, Spondylolisthesis, Spondylosis
Conditions
Keywords
Spine, Aspen device, PLIF, Low back pain
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.
Interventions
DEVICEPLIF and Aspen (spinous process fixation device)
Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device
Sponsors
American British Cowdray Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index Score Change | 12 months | Change between Oswestry Disability Index between pre-operative and final 12 months socores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rolland Morris Score | 12 months | Change in score in the Rolland Morris Score (RMS) |
| Visual Analogue Scale | 12 months | Change in pain measured by the visual analogue scale |
| Bone fusion (arthrodesis) | 12 months | Adequate bone fusion measured by computed tomography (CT) scan |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative parameters | At surgery | Surgery time, blood loss |
Countries
Mexico
Contacts
Primary ContactEduardo Galvan, MD
Outcome results
None listed