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A Study Comparing Either Cervical Spine, Head, Temporal Bone or Vasculature Treated with Metallic Implants Imaged with CT or MRI or Cerebral Angiogram to a MRI Zero Echo Time (ZTE) MRI Sequence
Rochester, MN
The purpose of this study is to demonstrate the use of 3D ZTE imaging of the cervical spine to assess osseous neural foraminal stenosis and directly compare it to CT. Other objectives will include evaluation of ossification of the posterior longitudinal ligament, ossification of disc herniations, and comparison of ZTE derived imaging of pedicle morphology to the current reformats provided by CT. The ability to image metallic hardware with ZTE will also be assessed, if present; 56 participants. Other cohorts being added is for those who are returning for aneursym ablation follow-up with medically indicated head MRI (adding reserach ZTE sequence) ...
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Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
Rochester, MN
The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.
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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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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 to Assess Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography
Rochester, MN
The purpose of this study is to assess wound perfusion at the site of closure in primary spine surgery between running subcuticular suture, interrupted vertical mattress suture, and staple closure techniques.
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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 Treatment of Lumbar Spinal Stenosis (LSS) with the MILD Procedure
Rochester, MN
The purpose of this study is to examine functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control.
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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 to Evaluate Post-surgical Outcomes Using the Early Recovery After Surgery (ERAS) Protocol for Posterior Cervical Decompression and Fusion
No Locations
The purpose of this study is to examine the role of an Early Recovery After Surgery (ERAS) protocol designed for posterior cervical spinal fusion.
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A Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Rochester, MN
The primary purpose of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine surgeries where both groups are receiving a multimodal pain regimen.
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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.
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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.