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A Pivotal Study Of The Premia Spine TOPS™ System
Rochester, MN
The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule. Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.
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A Study to Evaluate the Blood Test Thromboelastogram (TEG) to Manage Patients Undergoing Multi-level Spinal Fusion Surgery
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate whether using a blood test called thromboelastogram (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce complications after surgery compared with the standard practices.
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A Study Of Comparing Patient Outcomes And Satisfaction With Or Without Expert Panel Review Before Making A Final Decision About Surgery For Grade I Degenerative Lumbar Spondylolisthesis
Rochester, MN
The purpose of this study is to conduct a randomized control trial comparing patient outcomes and satisfaction with or without expert panel review before making a final decision about surgery for grade I degenerative lumbar spondylolisthesis.
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The MiDAS ENCORE Study
Rochester, MN
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
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A Study Of The Effectiveness Of EXPAREL For Pain Control In Adult Subjects Undergoing Open Lumbar Spinal Fusion Surgery
Rochester, MN
The purpose of this study is to compare postsurgical pain control following local infiltration analgesia and bupivacaine HCl with EXPAREL, versus without EXPAREL, in adult subjects undergoing open lumbar spinal fusion surgery. The study will also compare additional effectiveness, safety, and health economic outcomes.
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A Study of Bowel Function Return After One or Two Level Anterior Lumbar Interbody Fusion with Chewing Gum
Scottsdale/Phoenix, AZ
The purpose of this study is to observe changes in bowel pattern based on gum-chewing, examine bowel function after anterior lumbar interbody fusion, measure length of time to return of bowel function after anterior lumbar interbody fusion, compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care, measure the hospital length of stay amongst study groups, and measure post-operative pain amongst study groups.