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

NCT01918943 | Unknown

• 1 other identifier: ABC-Aspen-2013
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Spondylolisthesis; Spondylosis; Spinal Instability; Spinal Stenosis

Keywords

Spine; Aspen device; PLIF; Low back pain

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index Score Change

  Change between Oswestry Disability Index between pre-operative and final 12 months socores

  12 months

Secondary Outcomes (3)

• Rolland Morris Score

  12 months

• Visual Analogue Scale

  12 months

• Bone fusion (arthrodesis)

  12 months

Other Outcomes (1)

• Operative parameters

  At surgery

Study Arms (1)

PLIF and Aspen device patients

All patients will receive PLIF and Aspen device

Device: PLIF and Aspen (spinous process fixation device)

Interventions

PLIF and Aspen (spinous process fixation device) DEVICE

Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device

PLIF and Aspen device patients

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American British Cowdray Medical Center: lead

Study Sites (1)

American British Cowdray Medical Center

Mexico City, Mexico DF, 05300, Mexico

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Spondylolisthesis; Spondylosis; Spinal Stenosis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Roberto De Leo Vargas, MD

  Centro Medico ABC

  STUDY DIRECTOR

• Maximino Tellez, MD

  Centro Medico ABC

  STUDY CHAIR

• Rodrigo Navarro, MD

  Centro Medico ABC

  STUDY CHAIR

Central Study Contacts

Eduardo Galvan, MD

CONTACT

52(55)16647205; egalh@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 8, 2013
• Study Start: August 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 8, 2013

Record last verified: 2013-08

Locations

ME (1)