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Clinical Studies
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Characterization of Healthy and Degenerated Facet Joint Articular Cartilage, Bone, and Disc and Endplate Cartilage
Rochester, Minn.
The purpose of this study is to determine the biomechanical, biochemical, and histological properties of human spinal cartilage, in both healthy and degenerated patients, and to compare the properties among the different regions of the spine (cervical, thoracic, and lumbar).
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CSF Biomarker Evaluation in Idiopathic Normal Pressure Hydrocephalus (BioINPH)
Rochester, Minn.
The purpose of this study is to further characterize the serum and Cerebral Spinal Fluid (CSF) biomarker profile of idiopathic normal pressure hydrocephalus, both before and after VP shunt placement, and help differentiate this profile from Alzheimer’s disease.
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Real-World Functional Activity in Adult Spinal Deformity Surgery
Rochester, Minn.
The purpose of this study is to measure objective functional activity and gait and trunk stability in spinal deformity patients utilizing motion analysis testing and accelerometers. This will provide real-world data and evidence in optimizing care for spinal deformity patients.
Closed for Enrollment
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A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact (P080013b) as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
Subjects who have consented to participate in this study prior to undergoing spinal surgery and experience a durotomy, will be considered for study enrollment.
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A Placebo-Controlled Efficacy in iNPH Shunting (PENS) Trial (PENS)
Rochester, Minn.
The Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is an investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt effectiveness in iNPH patients.
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Prospective Radiographic And Clinical Evaluation Of Spinal Deformity Surgery
Rochester, Minn.
The purpose of this study is to establish a database of patients undergoing treatment for spine deformity, whether operative or non-operative, for the purpose of determining and assessing outcomes in affected patients.
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Prospective Study of Clinical Outcomes Following CSF Shunting for Idiopathic Normal Pressure Hydrocephalus (iNPH)
Rochester, Minn.
The purpose of this study is to collect data to objectively monitor the clinical outcomes of patients following CSF shunting for the treatment of idiopathic normal pressure hydrocephalus in order to optimize the surgical care of patients with this disease.
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SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial (SILVIA)
Rochester, Minn.
The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.
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