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A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

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ClinicalTrials.gov Identifier: NCT01972256
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Baxano Surgical, Inc.

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
Pseudoarthrosis Spinal Stenosis Spondylolisthesis Degenerative Disc Disease (DDD)

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 Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prospective Multicenter Clinical Evaluation of Fusion
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Group/Cohort
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).



Primary Outcome Measures :
  1. Efficacy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject candidates are those who had required fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Criteria

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

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): NCT01972256


Locations
United States, Florida
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States, 33637
United States, Indiana
Indiana Spine Group
Indianapolis, Indiana, United States, 46032
United States, Louisiana
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, United States, 70808
United States, Michigan
Michigan Spine Institute
Waterford, Michigan, United States, 48327
United States, Texas
Brazos Spine
College Station, Texas, United States, 77845
Sponsors and Collaborators
Baxano Surgical, Inc.

Responsible Party: Baxano Surgical, Inc.
ClinicalTrials.gov Identifier: NCT01972256     History of Changes
Other Study ID Numbers: PR-0023
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Pseudarthrosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Fractures, Ununited
Fractures, Bone
Wounds and Injuries