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
|Condition or disease|
|Spinal Stenosis Spondylolisthesis Degenerative Disc Disease (DDD)|
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:
Safety: Incidence of reported adverse events, including those requiring medical intervention, by 3 months post-operative.
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
|Transsacral lumbar interbody fusion|
|Transforaminal lumbar interbody fusion|
- Safety [ Time Frame: 3 months post-operative ]Incidence of reported adverse events, including those requiring medical intervention.
- 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
- 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
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
|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|
|Study Director:||Peter Whang, MD||Yale School of Medicine|