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

• Conditions: Low Back Pain; Spondylolisthesis; Spondylosis; Spinal Instability; Spinal Stenosis
• Interventions: Device: PLIF and Aspen (spinous process fixation device)

• Registration Number: NCT01918943
• Lead Sponsor: American British Cowdray Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2013-08
• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-06
• Last Update Submitted: 2013-08-06
• Study First Posted: 2013-08-08
• Last Update Posted: 2013-08-08
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PLIF and Aspen device patients	PLIF and Aspen (spinous process fixation device)	All patients will receive PLIF and Aspen device

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index Score Change	12 months	Change between Oswestry Disability Index between pre-operative and final 12 months socores

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

American British Cowdray Medical Center; 🇲🇽 Mexico City, Mexico DF, Mexico