A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

NCT01972256 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2014-06-04

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or bilateral supplemental screw fixation as an adjunct to fusion.

Subject candidates are those who had previously required and received fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

Conditions

  • Pseudoarthrosis
  • Spinal Stenosis
  • Spondylolisthesis
  • Degenerative Disc Disease (DDD)

Sponsors & Collaborators

  • Baxano Surgical, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

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 NCT01972256 on ClinicalTrials.gov