Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Low Back Pain, Spondylolisthesis, Spondylosis, Spinal Instability, Spinal Stenosis

Intervention / Treatment
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* Device: PLIF and Aspen (spinous process fixation device)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PLIF and Aspen device patients<br>All patients will receive PLIF and Aspen device | Device: PLIF and Aspen (spinous process fixation device)<br>* Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index Score Change | Change between Oswestry Disability Index between pre-operative and final 12 months socores | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 months | 
| Bone fusion (arthrodesis) | Adequate bone fusion measured by computed tomography (CT) scan | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine, Aspen device, PLIF, Low back pain