research

Spine - Lumbar

OrthoFix Spinal Stim:
This research is being conducted so that we can better understand how the SpinalStim™ bone growth stimulator helps with healing following lumbar fusion surgery. The amount of healing will be determined by looking at x-rays and CT scans of the spine 12 months after surgery. The study device will be used for 6 of these 12 months. The study device is already approved for use in the United States so this is considered a post-marketing study. The study device is battery operated and uses electricity to create a magnetic field. When placed near the site of fusion, the magnetic field stimulates bone growth. The study device is non-invasive and is worn over the site of fusion, with the help of a brace.
 

TOPS IDE Artificial Facet: The study is designed to assess the ability of the TOPS System to relieve the pain and restore normal function caused by certain spinal conditions. The purpose of the study is to compare the results of spinal surgery using the TOPS System to the results of spinal fusion surgery. Currently, fusion surgery is a standard treatment for people with these symptoms. The spinal column is made up of many joints which allow the body to bend, twist and move. Pain often results when there is something wrong with these joints. Fusing diseased vertebrae together stabilizes the spine. However, fusing the vertebral bones also makes them incapable of moving normally. A spinal implant such as the TOPS System is intended as an alternative to fusion surgery because it is designed to relieve pain while still allowing movement of the joints between the vertebrae.


NuTech NuCel: A  Prospective, Efficacy Study of NuCel® in Patients UndergoingFusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine: For patients 21 years and older currently scheduled to have 1, 2, or 3 level lumbar decompression and fusion for Degenerative Disc Disease and/or spondylolisthesis. For more detailed information about this study, please click here.


Spine Wave Annex Prospective: A Prospective Clinical Evaluation of the Annex™ Adjacent Level System: This post-market clinical investigation is to evaluate the Annex™ Adjacent Level System for the treatment of ALD in comparison to conventional pedicle screw systems. The Annex™ Adjacent Level System has been designed to allow for additional fusions in patients with previous fusion surgeries without having to remove the hardware from the original fusion. Treated patients may benefit from reduced surgical times and intra-operative blood loss when compared to conventional treatments. The Annex™ Adjacent Level System can also be implanted through a minimally invasive approach (MIS); therefore, patients may also benefit from reduced complications, length of hospital stay, and post-op narcotics use. For more detailed information about this study, please click here.
 

Strive: A phase 2b, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a Staphylococcus aureus 4-antigen vaccine (SA4Ag) in adults undergoing elective posterior instrumented lumbar spinal fusion procedures. The purposes of the clinical trial is to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery. For more information click here.


NuVasive 1503: A Prospective Multicenter Study Evaluating the Clinical and Radiographic Outcomes of Thoracolumbar Spine Surgery When Comprehensive Sagittal Alignment Surgical Planning is Used. This research is being done to measure the value of Software planning tools used by a surgeon before and during surgery can help him or her make a surgical plan using a combination of procedures, techniques and implants, which help to make sure spinal alignment is in balance after surgery. For more information click here.


Spine – Cervical

OrthoFix Cervical Stimulator: This research is being conducted so that we can better understand how the CervicalStim™ bone growth stimulator helps with healing following cervical fusion surgery. The amount of healing will be determined by looking at x-rays and CT scans of the spine 12 months after surgery. The study device will be used for 6 of these 12 months. The study device is already approved for use in the United States so this is considered a post-marketing study. The study device is battery operated and uses electricity to create a magnetic field. When placed near the site of fusion, the magnetic field stimulates bone growth. The study device is non-invasive and is worn over the site of fusion, with the help of a brace.


Simplify Cervical Artificial Disc: Clinical Study Protocol for the Investigation of the Simplify™ Cervical Artificial Disc This study involves research into the safety and effectiveness of the Simplify™ Disc for patients who are undergoing a discectomy (removal of a cervical disc) at one level due to arm pain and/or neurological symptoms (such as weakness or numbness) with or without neck pain, have specific findings on imaging studies such as X-ray, CT, or MRI, and have not responded to at least six weeks of non-surgical care such as physical therapy, medicines, or injections. This research study will compare outcomes after surgery with the Simplify Disc to outcomes after ACDF fusion surgery.


Simplify 2 Level Cervical Artificial Disc: Clinical Study Protocol for the Investigation of the Two Level Simplify™ Cervical Artificial Disc This study involves research into the safety and effectiveness of the Simplify™ Disc for patients who are undergoing a discectomy (removal of a cervical disc) at two adjacent levels due to arm pain and/or neurological symptoms (such as weakness or numbness) with or without neck pain, have specific findings on imaging studies such as X-ray, CT, or MRI, and have not responded to at least six weeks of non-surgical care such as physical therapy, medicines, or injections. This research study will compare outcomes after surgery with the Simplify Discs to outcomes after ACDF fusion surgery.


Spinal Cord Injury

INVIVO Scaffold: Pilot Study of Clinical Safety and Feasibility of the PLGA-POLY-L-LYSINE Scaffold for the Treatment of Complete (ASIA A) Traumatic Acute Spinal Cord Injury: The purpose of this study is to assess the safety of a new medical device for a recent spinal cord injury. Patients may be candidates for this study if they have had a spinal cord injury within the previous 10 days. The new treatment will be added to the usual, standard treatment for spinal cord injury. If they join the study, they will also receive all standard of care treatments. Potential patients will have a spinal cord injury with likely irreversible changes to their body. Currently there are various forms of therapy and medications to help this condition, but there is no treatment for curing spinal cord injury and reversing the damage. For more detailed information about this study, click here.


Other Studies

Wingspan™ Stent System with Gateway PTA Balloon Catheter: (Humanitarian Use Device)- For use in treatment of lesion within the brain, caused by atherosclerosis (narrowing and hardening of the arteries) and its affect on the neurovascular arteries that are in the brain.


Boston Scientific Target NEUROFORM™ Microdelivery Stent System (Humanitarian Use Device) – for use in treatment of wide-neck, intracranial aneurysms.



PCORI CER-1503-29700 Posterior Fossa Decompression with or without Duraplasty for Chiari type I Malformation with Syringomyelia This is a trial for patients under the age of 21 who have Chiari I Malformation (CM), a neurological condition in which a part of the brain, the cerebellum, protrudes out of the skull and into the spinal canal. This causes compression of parts of the brain and spinal cord, disrupting the normal flow of cerebrospinal fluid. In some people, CM causes the accumulation fluid in the spinal cord itself, termed syringomyelia (SM). CM+SM is usually treated with posterior fossa decompression, a surgical procedure directed at reestablishing normal cerebrospinal fluid flow, relieving symptoms, and stabilizing or reducing the SM.

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