Spinal Stenosis Clinical Trial
Official title:
Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
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.
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.
;
Observational Model: Cohort, Time Perspective: Retrospective
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