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

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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain; Spinal Stenosis; Spondylosis; Spondylolisthesis; Spinal Instability
• Intervention / Treatment: Device: PLIF and Aspen (spinous process fixation device)

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Eduardo Galvan, MD; Phone Number: 52(55)16647205; Email: egalh@yahoo.com

Study Locations

• Mexico
  • Mexico DF
    • Mexico City, Mexico DF, Mexico, 05300
      • Recruiting
      • American British Cowdray Medical Center
      • Sub-Investigator: Karla Moctezuma, MD
      • Sub-Investigator: Rodrigo Navarro Ramirez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PLIF and Aspen device patients; All patients will receive PLIF and Aspen device	Device: PLIF and Aspen (spinous process fixation device); Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative parameters	Surgery time, blood loss	At surgery

Collaborators and Investigators

• Sponsor: American British Cowdray Medical Center
• Investigators: Study Director: Roberto De Leo Vargas, MD, Centro Médico ABC; Study Chair: Maximino Tellez, MD, Centro Médico ABC; Study Chair: Rodrigo Navarro, MD, Centro Médico ABC

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ANTICIPATED): August 1, 2015
• Study Completion (ANTICIPATED): August 1, 2015

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (ESTIMATE): August 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Low back pain; Spine; Aspen device; PLIF
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Back Pain; Low Back Pain; Spinal Stenosis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: ABC-Aspen-2013