research

Spine - Lumbar

DiscGenics DXG-A01: Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and two controls (saline, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1. This is a Phase I, first-in-human, randomized, double-blind, vehicle and placebo-controlled, parallel-group, multi-center study in subjects with single-level, symptomatic lumbar intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with two control groups (saline, Sodium Hyaluronate).

7 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 72 and week 104. The subject will be assessed for safety and efficacy utilizing questionnaires alongside radiographic evaluations. The study will have a 1 year follow-up and a 1 year extension period (total 2 years). Learn more here


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.


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 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.


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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