FDA-Regulated Clinical Trials
Evaluation of Safety and Effectiveness of the OsseoFix® Spinal Fracture Reduction System in Treating Spinal Compression Fracture
Principal Investigator: Alan T. Villavicencio, M.D.
Sub-Investigators: Lee Nelson, MD
Sponsor: Alphatec Spine, Inc.
Status: Enrolling patients
Alphatec Spine, Inc., is a medical device company that specializes in treating disorders that affect the aging spine. The company is conducting a clinical study with the OsseoFix® Spinal Fracture Reduction System which is for the treatment of vertebral compression fractures in the middle and lower back. The system provides internal fixation and stabilization using a permanent implant made of titanium and bone cement.
Some of the qualification criteria for study participation are the following:
- 50 years or older
- Recently diagnosed with a vertebral compression fracture and conservative therapy (medication, bed rest, bracing, etc.) has failed for you
- Diagnosed with Osteoporosis
If you feel you have some of the above qualifications, please speak with one of the study physicians about the possibility of participating in this study and what participation entails.
http://www.osseofixtrial.com
Wallis® System - Clinical Trial for Lumbar Degenerative Disc Disease
Principal Investigator: Alan T. Villavicencio, M.D.
Sub-Investigators: Lee Nelson, MD
Sponsor: Zimmer Spine
Status: No longer enrolling patients, follow-up only
Boulder Neurosurgical Associates participates in this clinical trial to establish the safety and effectiveness of the Wallis® System. The study compares the Wallis dynamic stabilization system to total lumbar artificial disc replacement.
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Participants in the trial are randomly selected to receive the Wallis device or a total lumbar disc replacement for the treatment of mild to moderate degenerative disc disease of the lumbar spine. The artificial disc is a FDA-approved, commercially-available implant designed to replace an entire diseased or damaged spinal disc through a surgery called “total disc replacement” (TDR). The Wallis System is designed to treat the pain caused by degenerative disc disease (DDD) by stabilizing the lumbar spine without a fusion procedure.
Boulder Neurosurgical Associates believes that by offering this clinical trial, it reinforces its commitment to give patients access to the latest investigational treatments for back pain.
Study objectives
The primary objective of the Wallis Clinical Study is to demonstrate that the Wallis System is equivalent to total disc replacement for the treatment of mild to moderate degenerative disc disease of the lumbar spine at the L4 – L5 level.
Study overview
Approximately 25 medical centers are enrolling patients into this clinical study to assess the safety and effectiveness of the Wallis System in the treatment of mild to moderate degenerative disc disease.
The study is randomized so that 50% of the study participants will receive a Wallis device and 50% will receive a commercially available artificial disc (either the CHARITÉ® or PRODISC-L® artificial disc). Patients will be randomly assigned to receive either surgical option.
Study participants will receive all study-related tests and surgical procedures at no charge.
In contrast to traditional fusion surgery, in which two or more vertebrae are fused together, the Wallis device and lumbar artificial discs are motion-preservation technologies that allow the spine to continue to move. The Wallis device is placed between the spinous processes – ridges of the spine – and acts as a stabilizing spacer that may relieve symptoms of degenerative disc disease.
What does it mean to have a Total Disc Replacement?
Total Disc Replacement (TDR) is a surgical procedure in which a diseased or damaged disc is replaced with a mechanical device (artificial disc) that behaves similarly to the body’s natural disc. Artificial discs have been approved by the FDA for sale in the United States. Like many spinal implants, an artificial disc (TDR) is implanted using an anterior approach, which means the surgeon inserts the device through an incision made near your belly button. The primary advantage of receiving the TDR is that, unlike current fusion implants used to treat degenerative discs, the design of the TDR device allows the treated area of the spine to maintain movement.
What are the potential benefits?
- May relieve pain without necessitating spinal fusion.
- Possibly preserves motion at the affected level unlike other surgical choices.
- The procedure may prevent adjacent level disc disease; a common problem associated with fusion surgeries.
What are the potential risks?
- May not relieve all of the patient’s back pain, or could potentially make it worse.
- The surgery is conducted through the abdomen rather than through the back. This can be more invasive.
- May complicate the need for further surgical intervention, such as a fusion in the event that symptoms persist.
- As with all surgeries, surgery-related complications may occur.
What is the Wallis device?
The Wallis device is a spinal implant that is surgically inserted between the bones in your back (called vertebrae). The device is designated to relieve low back pain caused by degeneration or damage to a disc in your spine. Disc degeneration can change the normal sagittal movements of and overall strength of the spine. Additionally, a degenerated disc may lose its ability to act as a shock absorber, which is important for day-to-day, pain-free living. These problems can progress to persistent low back pain.
The Wallis device attempts to restabilize or support the spine during the early stages of degeneration. It also aims to slow the breakdown of the disc while still allowing the spine to move normally.
Figure Legends: Plain x-rays (AP and lateral views with extension) taken three months after the surgery. A normal movement through L4-L5 could be observed). Unlike fusion surgeries, the Wallis device is designed to stabilize your spine without joining or “fusing” vertebrae.
The Wallis device is implanted using a posterior approach, which means it is inserted through a small incision in your back.
Click to watch a surgical animation.
Has it been used before?
The Wallis device was originally developed in Bordeaux, France and has been in use in various parts of the world since 1986. Outside the US, more than 12,000 patients have been treated with the Wallis device. Up to this point, the FDA has not cleared Wallis for the use in the United States. The aim of the Wallis study is to gain approval for the use here.
Who is a good candidate for the study?
The Wallis study is intended for people with mild degenerative disc disease in the lumbar spine. The cost of the Wallis or disc replacement procedure will be covered by the study.
Patients must also meet the following criteria in order to take part in the Wallis study:
- Age 18 – 60
- Have experienced at least six months of failed non-surgical or “conservative care” treatments (physical therapy, medications, back injection, etc.)
- Voluntarily read and sign the informed consent document
Who is not a good candidate for the study?
If one or more of the following apply, you will not be able to take part in the study:
- Disc problems at other than the L4-L5 levels
- Leg pain greater than back pain
- Unwilling to undergo surgery
- Bacterial infection
- Poor bone quality
- HIV or Hepatitis
- Lumbar Stenosis
- Pregnant
- Uncontrolled Diabetes
- Extreme obesity
- Prior participation in a clinical study of any investigational spinal implant or spinal treatment
- Previous fusion at the same or adjacent levels being studied
What are potential benefits?
- May relieve pain without requiring spinal fusion.
- Surgery is relatively conservative when compared to other surgical choices, like fusion or disc replacement.
- The Wallis procedure does not prevent the need for another procedure (e.g., fusion or disc replacement) if problems persist.
What are potential risks?
- May not relieve all of the patient’s back pain, or could potentially make it worse.
- Patient potentially could develop instability after surgery.
- As with all surgeries, surgery-related complications may occur.
To read more about this clinical trial please dowload the PDF, or contact us at 303-938-5700 if you have any questions.
To read about patient experience wallissurgery.blogspot.com.
The Advent™ Cervical Disc Clinical Trial
Boulder Neurosurgical Associates participates in a clinical trial for a new investigational device, namely the Advent™ Cervical Disc. The Advent™ Cervical Disc is one of the first cervical artificial discs for the treatment of one level degenerative disc disease to incorporate a flexible elastomer core, which is designed to provide advanced biomechanical properties.
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Figure: Advent Cervical Artificial Disc.
The purpose of the research study is to evaluate the safety and effectiveness of the Advent™ Cervical Disc in patients who have neck problems and that require surgery to replace the disc found between the cervical vertebrae following discectomy. Patients that have failed conservative treatment for at least six weeks for nerve root and/or spinal cord compression due a herniated disc and/or osteophyte formation between C3 and C7 may be eligible for enrollment in the study. Enrollment eligibility will be confirmed by patient history (e.g. neck and/or arm pain), functional and/or neurological deficit (e.g. numbness, weakness, diminished or pathologic reflexes, gait disturbances, etc.) and radiographic studies (e.g. CT, MRI, x-rays, etc.).
Caution: Investigational Device – Limited by Federal Law to Investigational Use
MAVERICK™ – FDA Lumbar Artificial Disc Study
Principal Investigator: Alan T. Villavicencio, M.D
Sponsor: Medtronic
Status: No longer enrolling patients
The MAVERICK™ artificial disc is a spinal arthroplasty system intended for use in the lumbar spine to treat degenerative disc disease. The device is a permanent implant that is intended to maintain motion at the treated level. While a fusion remains the standard of care, the artificial disc may provide an alternative solution for those patients suffering from degenerative disc disease.
Complete Listing
A multicenter clinical study was initiated in the United States in the spring of 2003 and is estimated to be completed by August, 2011. The clinical trial data will be submitted for approval by the US Food and Drug Administration (FDA) to commercialize the implant.
The purpose of this clinical trial is to evaluate 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 to S1. Patients who enroll in the clinical study are randomly assigned a treatment group. Approximately two-thirds of the patients receive the MAVERICK™ Artificial Disc and one-third of the patients receive the lumbar fusion.
Caution: Investigational device. Limited by Federal (United States) law to investigational use.
A Study Evaluating the Efficacy and Safety of Fibrin Sealant for the Sealing of Dura Defect Sutures in Posterior Fossa Surgery
Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: Lee Nelson, MD
Sponsor: Baxter Healthcare Corporation
Status: No longer enrolling patients
The purpose of this research is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura substitute sutures in preventing postoperative cerebrospinal fluid (CSF) leakage.
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In order to perform the brain surgery, the surgeon will cut through the skull (a procedure is known as a craniotomy) and through the dura (one of the tissue layers covering the brain). The space between the dura and the brain is filled with cerebral spinal fluid called CSF. The use of a sealant on top of the sutures used to close the opening in the dura may help control CSF leakage after the surgery. The product to be studied, Fibrin Sealant, Vapor Heated, Solvent/Detergent 500 s-apr (FS VH S/D 500 s-apr), is a fibrin sealant known as a surgical “glue” made out of two substances naturally found in the human body, thrombin and fibrinogen. When mixed together, they help to form a clot. The human body naturally absorbs the clot over a period of about 14 days.
This study will also look at how often infection occurs, if there are any side effects from the sealant, and what are the procedures required to treat CSF leakage after surgery. FS VH S/D 500 s-apr is investigational and is not approved by the U.S. Food and Drug Administration (FDA) for sealing dura sutures in the USA.
CAFÉ
Randomized Clinical Trial Comparing Balloon Kyphoplasty to Non-Surgical Treatment in Cancer Patients
Principal Investigator: Alan T. Villavicencio, M.D.
Sub-Investigators: Lee Nelson, MD
Sponsor: Kyphon
Status: No longer enrolling patients
Boulder Neurosurgical Associates has been selected to participate in a landmark international clinical trial for cancer patients who have experienced a fracture of the spine known as a vertebral compression fracture (VCF). Many cancer patients, especially those suffering with multiple myeloma, experience such fractures of the spine, which can cause debilitating back pain and substantially reduce their quality of life.
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The Cancer Patient Fracture Evaluation (CAFE) study is designed to compare the safety and effectiveness of two alternative treatments for painful, acute VCFs: a surgical treatment known as Balloon Kyphoplasty and non-surgical treatment.
Balloon Kyphoplasty is a minimally invasive spine procedure that has been shown in non-randomized clinical trials to relieve pain, improve function and quality of life, restore vertebral height and correct spinal deformity. To date over 210,000 patients worldwide have had VCFs treated with Balloon Kyphoplasty. Traditional non-surgical treatments for spinal fractures in cancer patients include bed rest, medication, back bracing, walking aids, radiation, and physical therapy.
The US Food and Drug Administration (FDA) has already cleared devices for use in Balloon Kyphoplasty for the treatment of VCFs in cancer patients. The purpose of this postapproval, randomized, controlled clinical trial is to collect further evidence that may support the Balloon Kyphoplasty treatment option. The study will evaluate a total of 200 patients at up to 30 centers across the United States, Canada, Europe and Australia.
Boulder Neurosurgical Associates has joined the CAFE trial as part of its dedication to improving the quality of life for people with cancer. Dr. Alan Villavicencio is one of the first to bring this new treatment option for cancer patients in Colorado and will be performing the Balloon Kyphoplasty procedures
