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A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

Sponsor
Baxano Surgical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01972256
Collaborator
(none)
60
Enrollment
5
Locations
10.1
Duration (Months)
12
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Consecutive subjects who were treated with the transsacral lumbar interbody fusion or TLIF procedures at least 2 years prior to the date the data is collected will be evaluated.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prospective Multicenter Clinical Evaluation of Fusion
    Study Start Date :
    Apr 1, 2013
    Actual Primary Completion Date :
    Feb 1, 2014
    Actual Study Completion Date :
    Feb 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Previous transsacral fusion

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy [Assessed at 2 years post-op or greater]

      Fusion of the targeted vertebral bodies (L4-L5-S1) at 24 months as determined by independent orthopedic surgeon reviewer interpretation of high resolution Computed Tomography (CT) scan.

    Secondary Outcome Measures

    1. Safety [2 years post-op]

      Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.

    Other Outcome Measures

    1. Additional Secondary Endpoint: Efficacy [Assessed at 2 years post-op]

      Comparative Lordosis of L4-S1 at 24-months as determined by an independent orthopedic surgeon reviewer's interpretation of 24-month lateral (neutral) radiographs compared to baseline.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult 18 years of age or older

    • Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD)

    • Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons

    • Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery

    Exclusion Criteria:

    • Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1

    • Subject who received lumbar fusion procedures at levels other than L4-L5-S1 at the time of surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Foundation for Orthopaedic Research and Education Tampa Florida United States 33637
    2 Indiana Spine Group Indianapolis Indiana United States 46032
    3 Bone and Joint Clinic of Baton Rouge Baton Rouge Louisiana United States 70808
    4 Michigan Spine Institute Waterford Michigan United States 48327
    5 Brazos Spine College Station Texas United States 77845

    Sponsors and Collaborators

    • Baxano Surgical, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baxano Surgical, Inc.
    ClinicalTrials.gov Identifier:
    NCT01972256
    Other Study ID Numbers:
    • PR-0023
    First Posted:
    Oct 30, 2013
    Last Update Posted:
    Jun 4, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Spinal Stenosis
    Intervertebral Disc Degeneration
    Spondylolisthesis
    Pseudarthrosis

    Study Results

    No Results Posted as of Jun 4, 2014