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

NCT01918943 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2013-08-08

No results posted yet for this study

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

Interventions

DEVICE

PLIF and Aspen (spinous process fixation device)

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

Sponsors & Collaborators

  • American British Cowdray Medical Center

    lead OTHER

Principal Investigators

  • Roberto De Leo Vargas, MD · Centro Medico ABC

  • Maximino Tellez, MD · Centro Medico ABC

  • Rodrigo Navarro, MD · Centro Medico ABC

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918943 on ClinicalTrials.gov