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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLIF and Aspen device patients | All patients will receive PLIF and Aspen device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLIF and Aspen (spinous process fixation device) | Device | Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index Score Change | Change between Oswestry Disability Index between pre-operative and final 12 months socores | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rolland Morris Score | Change in score in the Rolland Morris Score (RMS) | 12 months |
| Visual Analogue Scale | Change in pain measured by the visual analogue scale |
| Measure | Description | Time Frame |
|---|---|---|
| Operative parameters | Surgery time, blood loss | At surgery |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Galvan, MD | Contact | 52(55)16647205 | egalh@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Roberto De Leo Vargas, MD | Centro Medico ABC | Study Director |
| Maximino Tellez, MD | Centro Medico ABC | Study Chair |
| Rodrigo Navarro, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American British Cowdray Medical Center | Recruiting | Mexico City | Mexico DF | 05300 | Mexico |
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| 12 months |
| Bone fusion (arthrodesis) | Adequate bone fusion measured by computed tomography (CT) scan | 12 months |
| Centro Medico ABC |
| Study Chair |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D013168 | Spondylolisthesis |
| D055009 | Spondylosis |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013169 | Spondylolysis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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