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Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures

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ClinicalTrials.gov Identifier: NCT02171169
Recruitment Status : Unknown
Verified September 2014 by Baxano Surgical, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : June 24, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Baxano Surgical, Inc.

Brief Summary:
The purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and comply with US regulations and requirements.

Condition or disease
Spinal Stenosis Spondylolisthesis Degenerative Disc Disease (DDD)

Detailed Description:

Study Objective:

The study objective is to demonstrate via retrospective data review the relative value of two lumbar fusion procedures: transsacral lumbar interbody fusion and the transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Subject candidates are those who had required fusion at L5-S1 where this was the only lumbar level treated for spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

Consecutive subjects who were treated with the transsacral lumbar interbody fusion or transforaminal lumbar interbody fusion procedure at least 1 year (- 2 months) prior to the date the data is collected will be evaluated.

Study Design, Endpoints:

Primary Endpoint:

Safety: Incidence of reported adverse events, including those requiring medical intervention, by 3 months post-operative.

Secondary Endpoints:

Health Economic: Operative measures, including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge, as applicable.

Health Economic: Comparative hospital data (from time of admission through time of discharge)

Clinical Effectiveness: A decrease in back pain compared to baseline at 3 months (+/-2 weeks) as measured by Visual Analog Scale (VAS).

Clinical Effectiveness: A decrease in disability compared to baseline at 3 months (+/-2 weeks) as measured by the Oswestry Disability Index (ODI).

Study Design, Enrollment:

Approximately 200 subjects will be enrolled in this study, 100 subjects who have been treated with transsacral lumbar interbody fusion and 100 subjects who have been treated with transforaminal lumbar interbody fusion.

Study Design, Analyses:

The retrospective clinical evaluation will collect and compare results for the procedure transsacral lumbar interbody fusion versus transforaminal lumbar interbody fusion as defined by the primary and secondary endpoints.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
Study Start Date : June 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Transsacral lumbar interbody fusion
Transforaminal lumbar interbody fusion



Primary Outcome Measures :
  1. Safety [ Time Frame: 3 months post-operative ]
    Incidence of reported adverse events, including those requiring medical intervention.


Secondary Outcome Measures :
  1. Health Economic [ Time Frame: Up to 3 months post-operative ]

    Operative measures including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge.

    Comparative hospital data


  2. Clinical Effectiveness [ Time Frame: 3 months post-operative ]
    A decrease in back pain compared to baseline at 3 months as measured by Visual Analog Scale A decrease in disability compared to baseline at 3 months as measure by the Oswestry Disability Index



Information from the National Library of Medicine

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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 that have been treated with either the transsacral or transforaminal lumbar interbody fusion procedure at least one year prior to this evaluation.
Criteria

Inclusion Criteria:

  • Adult aged 18 years or older
  • Male or Female subject that had previously received transsacral single-level procedure when used in conjunction with bilateral pedicle screw fixation or TLIF single-level procedure with bilateral supplemental screw fixation (e.g. pedicle screws, anterior devices with screw anchoring, anterior lumber plates) as an adjunct to fusion at L5-S1 to treat spinal stenosis, spondylolithesis or degenerative disc disease (DDD)
  • Subject that was treated no less than 1 year (-2 months) prior to this evaluation with a transsacral or TLIF procedure by participating surgeons

Exclusion Criteria:

  • Subject had history of previous back operations at the time of the index procedure
  • Subject had extraspinal cause of back pain or sciatica at the time of the index procedure
  • Severe scoliosis in the lumbar region
  • Subject was or is currently involved in active litigation
  • Subject that had a diagnosis and received a transsacral or TLIF procedure at L5-S1 levels and did not require treatment at any other lumbar levels 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): NCT02171169


Locations
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United States, California
St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
United States, Michigan
Michigan Spine Institute
Waterford, Michigan, United States, 48328
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Baxano Surgical, Inc.
Investigators
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Study Director: Peter Whang, MD Yale School of Medicine

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Responsible Party: Baxano Surgical, Inc.
ClinicalTrials.gov Identifier: NCT02171169     History of Changes
Other Study ID Numbers: PR-07875
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis