Medical Education & Research
In an ongoing effort to identify the optimal treatment of spinal disorders, The Virginia Spine Institute is dedicated to both science and clinical research. This commitment ensures that VSI remains at the leading edge of technology. Our patients benefit from the latest in scientific breakthroughs with access to the most up-to-date treatment options. For more information fill out our Contact Us form and specify which clinical trial you are interested in.
We are currently involved in the following clinical trials:
E-STIM (This study is no longer recruiting participants)
The E-STIM Trial is designed to collect data on the efficacy of the Empi Select Transcutaneous Electrical Nerve Stimulation (TENS) device for the treatment of chronic low back pain. This clinical trial is a non-significant risk, randomized, double-blinded, placebo-controlled 12-week trial involving the commercially available Empi Select TENS device for treating subjects with chronic (>90 days) low back pain. Multiple centers located in the United States will enroll approximately 300 subjects in this study. Eligible subjects will be randomized 1:1 to either the treatment group or the placebo group. The subjects and investigational staff are blinded to the treatment assignment. Subjects will return to the investigational center for follow-up assessments at 1, 4, 8, and 12 weeks.
ACCESS (This study is no longer recruiting participants)
Long-term treatment of chronic pain with opioids is recognized as an important treatment option for patients with moderate-severe pain related to cancer and other chronic serious illnesses. AVINZA (morphine sulfate extended-release capsules) was approved for marketing by the Food and Drug Administration (FDA) in 2002 as a once daily treatment for the relief of moderate to severe pain requiring continuous opioid therapy for an extended period of time. While opioids, such as AVINZA, are beneficial in the management of chronic pain, they are sometimes associated with illicit activities. Misuse, abuse and diversion of controlled prescription drugs, particularly opioids, are problems that have increased dramatically in the United States (U.S.) since the 1990s.
This study will follow the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain. Patients will be counseled on the proper storage and destruction of unused AVINZA in accordance with federal and applicable state laws. A universal precautions approach to chronic pain management (KAIR) will be utilized in this study. Although not validated as a risk assessment and management instrument, KAIR is designed to assist clinicians with responsibly managing chronic moderate-severe pain patients prescribed AVINZA. The KAIR tools will be used by the Investigator to determine the level of monitoring required based on the patient's potential risk for opioid misuse or abuse (KAIR level). Investigators and staff participating in this study will be required to participate in a training program on the counseling to be given, procedures to be followed and tools to be used in this study.
Maverick (This study is no longer recruiting participants)
The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will be examined.
Prestige (This study is no longer recruiting participants)
This pivotal clinical trial is being conducted to compare treatment data of the investigational implant device, the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc device will be implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (IDE # G010188)will be compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.
Cervical Bone Morphogenetic Protein Study
This clinical trial involves anterior cervical interbody fusion and posterior cervical fusions in the treatment of patients with symptomatic degenerative cervical disc disease. Corticocancellous allograft interbody devices will be used in the surgical treatment of some trial patients. All patients will receive recombinant human bone morphogenetic protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) and implanted into the cervical spine. There is only one study group; all of these patients are in the investigational group receiving rhBMP-2 bone graft. Some patients will undergo anterior cervical plate fixation.
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