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A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxano Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT01972256
First received: October 24, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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
Pseudoarthrosis
Spinal Stenosis
Spondylolisthesis
Degenerative Disc Disease (DDD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prospective Multicenter Clinical Evaluation of Fusion

Resource links provided by NLM:


Further study details as provided by Baxano Surgical, Inc.:

Primary Outcome Measures:
  • Efficacy [ Time Frame: Assessed at 2 years post-op or greater ] [ Designated as safety issue: No ]
    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:
  • Safety [ Time Frame: 2 years post-op ] [ Designated as safety issue: Yes ]
    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:
  • Additional Secondary Endpoint: Efficacy [ Time Frame: Assessed at 2 years post-op ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: April 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Baxano Surgical, Inc.
ClinicalTrials.gov Identifier: NCT01972256     History of Changes
Other Study ID Numbers: PR-0023
Study First Received: October 24, 2013
Last Updated: June 3, 2014
Health Authority: United States: Western Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014