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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Galvan Ernesto Eduardo, American British Cowdray Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01918943
First Posted: August 8, 2013
Last Update Posted: August 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galvan Ernesto Eduardo, American British Cowdray Medical Center
  Purpose

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.


Condition Intervention
Low Back Pain Spondylolisthesis Spondylosis Spinal Instability Spinal Stenosis Device: PLIF and Aspen (spinous process fixation device)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Galvan Ernesto Eduardo, American British Cowdray Medical Center:

Primary Outcome Measures:
  • Oswestry Disability Index Score Change [ Time Frame: 12 months ]
    Change between Oswestry Disability Index between pre-operative and final 12 months socores


Secondary Outcome Measures:
  • Rolland Morris Score [ Time Frame: 12 months ]
    Change in score in the Rolland Morris Score (RMS)

  • Visual Analogue Scale [ Time Frame: 12 months ]
    Change in pain measured by the visual analogue scale

  • Bone fusion (arthrodesis) [ Time Frame: 12 months ]
    Adequate bone fusion measured by computed tomography (CT) scan


Other Outcome Measures:
  • Operative parameters [ Time Frame: At surgery ]
    Surgery time, blood loss


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918943


Contacts
Contact: Eduardo Galvan, MD 52(55)16647205 egalh@yahoo.com

Locations
Mexico
American British Cowdray Medical Center Recruiting
Mexico City, Mexico DF, Mexico, 05300
Contact: Ernesto E Galvan Hernandez, MD, MsC    16647205 ext 4155    egalh@yahoo.com   
Principal Investigator: Ernesto E Galvan Hernandez, MD, MsC         
Sub-Investigator: Roberto De Leo, MD         
Sub-Investigator: Miguel Angel Collado Corona, MD         
Sub-Investigator: Karla Moctezuma, MD         
Sub-Investigator: Maximino Tellez Gutierrez, MD         
Sub-Investigator: Ildelfonso Muñoz Romero, MD         
Sub-Investigator: Rodrigo Navarro Ramirez, MD         
Sponsors and Collaborators
American British Cowdray Medical Center
Investigators
Study Director: Roberto De Leo Vargas, MD ABC Medical Center
Study Chair: Maximino Tellez, MD ABC Medical Center
Study Chair: Rodrigo Navarro, MD ABC Medical Center
  More Information

Responsible Party: Galvan Ernesto Eduardo, MD, American British Cowdray Medical Center
ClinicalTrials.gov Identifier: NCT01918943     History of Changes
Other Study ID Numbers: ABC-Aspen-2013
First Submitted: August 6, 2013
First Posted: August 8, 2013
Last Update Posted: August 8, 2013
Last Verified: August 2013

Keywords provided by Galvan Ernesto Eduardo, American British Cowdray Medical Center:
Spine
Aspen device
PLIF
Low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Spinal Stenosis
Spondylolisthesis
Spondylosis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis