| |
Clinical Trials
Dr. Regan is one of a few selected surgeons who are participating in Food and Drug Administration clinical trials for the Anatomic Facet Replacement System (AFRS™), a treatment that preserves normal motion and is an alternative to lumbar spinal fusion for lumbar spinal stenosis patients.
Other clinical trial studies taking place at Dr. Regan's practice include the nanOss Bioactive, a prospective, multi-center, nonrandomized study to assess lumbar fusion using interbody cages with autograft along with instrumented posterolateral gutter fusions using nanOss Bioactive.
And VertiFlex, a study comparing the VertiFlex® Superion™
Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®)
System in Patients with Moderate Lumbar Spinal Stenosis. Read more below.
Please review this information to determine if you might qualify for participation in one of these trials. For additional information on any of these trials, or to schedule an appointment for a second opinion or phone consult, contact Nicole Blackwell at either (310) 574-0414 or nblackwell@discmdgroup.com.
[Top]
Anatomic Facet Replacement System Clinical Trial
The Investigational Plan for the Evaluation of the Anatomical Facet Replacement System (AFRS)
Degeneration of the facet joints often leads to spinal stenosis and as the degeneration continues, many patients require surgery to regain spinal stability and obtain relief from pain. A common surgical treatment is the removal of bone from the affected area followed by a spinal fusion, which limits normal motion.
The Anatomic Facet Replacement System (AFRS) is a treatment that preserves normal motion and is an alternative to lumbar spinal fusion for lumbar spinal stenosis patients.
To learn more information about lumbar spinal stenosis treatment, visit www.stenosisrelief.com.
The Procedure:
With the AFRS, the degenerated facet is replaced with a moveable joint. Like the original facet joint, the replacement implant is designed to enable normal motion while restoring stability.
The implant is made from a cobalt chrome alloy with highly polished moveable surfaces, which replicates the construction of total knee and hip replacements. The backing of the implant that touches the bone is coated to promote bony in-growth. Different implants are used for inferior and superior facets and they are produced in a variety of sizes to meet individual physical and anatomical requirements.
In order to determine the effectiveness of this facet implant, we will be comparing the study device to a currently FDA approved procedure that is commonly prescribed for treatment of this condition, known as an instrumented posterolateral fusion. Therefore, in choosing to participate in this study, you would be randomly selected to receive either the study device (AFRS) or the posterolateral fusion.
Inclusion Criteria:
- Be between the ages of 21 and 85
- Have received at least 6 months of non-operative spinal treatment prior to surgery.
- Have lateral, lateral recess and/or central canal stenosis, nerve root involvement, or evidence of facet problems at a single level from L3 to L5.
- Have greater leg pain than back pain.
- Be a candidate for a decompression with full facetectomy.
- Be a candidate for a transforaminal or posterior lumbar interbody fusion.
- Not be pregnant at the time of surgery
- Must be willing to comply with all follow-up visits for 2 years
Exclusion Criteria:
- Patients who have an active infection at the L3 to L5 levels or a systemic infection including prior or pending treatment for HIV or Hepatitis C
- Patients who have had a previous surgical procedure at L3 to L5 levels, except for one of the following: microdiscectomy, laminectomy, laminotomy, rhizotomy, IDET, and/or inter-spinous spacer.
- Patients with certain levels of osteoporosis.
- Have spinal stenosis of three or more lumbar segments.
- Patients who have had injury to the lumbar spine
- Patients with a metabolic bone disease, such as Paget's disease
- Patients with spondylolisthesis at levels other than the involved level
- Patients with certain levels of scoliosis of the lumbar spine
- Patients who have a BMI (body mass index) of greater than 40
- Patients who are insulin-dependent diabetics
- Patients who have a history of cancer (except for non-melanoma skin cancer) within the last 5 years
- Patients who have participated in a clinical drug or device trial within the last 30 days
- Patients who is currently receiving workman’s compensation
Additional Questions on Trial Participation:
For additional information on this trial, contact Nicole Blackwell at either (310) 574-0414 or nblackwell@discmdgroup.com.
nanOss Bioactive
A prospective, multi-center, nonrandomized study to assess lumbar fusion using interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss Bioactive.
Purpose: This study will evaluate the device nanOss Bioactive which has already been approved by the Food and Drug Administration for several uses, including spinal fusion. nanOss Bioactive is a bone graft material that helps fuse the vertebrae or bones in your back by providing a surface for new bone to grow.
Inclusion Criteria:
-
Male or female at least 18 years of age and skeletally mature.
-
Must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease at one or two adjacent levels from L2-S1 requiring a fusion.
-
Must have completed a minimum of three months of unsuccessful non-operative care.
-
Must have discogenic back pain with or without leg pain.
-
Must understand and sign the informed consent document and be able to comply with the protocol’s follow-up schedule.
Exclusion Criteria:
-
Symptomatic at more than two levels.
-
Previous fusion surgery at any lumbar level with or without instrumentation.
-
More than 50% spondylolisthesis.
-
Lumbar scoliosis greater than 11 degrees.
-
Osteoporosis, osteopenia, osteomalacia, Paget’s disease or metablic bone disease.
-
Spinal tumors.
-
Active arachonoiditis.
-
Rheumatoid arthritis or other autoimmune disease.
-
Systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis.
-
Smokers unless agree to quit at least 2 weeks prior to and for the duration of the study.
-
Psychosocial disorders or a history of substance abuse.
-
History of any invasive malignancy unless treated and in remission for at least five years.
-
Pregnancy or interested in becoming pregnant in the next four years.
Additional Questions on Trial Participation:
For additional information on this trial, contact Nicole Blackwell at either (310) 574-0414 or nblackwell@discmdgroup.com.
[Top]
VertiFlex
A Prospective, Multi-center, Randomized Study Comparing the VertiFlex® Superion™
Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®)
System in Patients with Moderate Lumbar Spinal Stenosis
Purpose: The Superion™ Interspinous Spacer is a new minimally invasive spinal implant that limits extension at the symptomatic level designed for percutaneous surgical techniques. The device is intended to treat moderate spinal stenosis in the adult spine and can be implanted under general anesthesia or local anesthesia with or without conscious sedation.
Inclusion Criteria:
-
Male or female subjects >= 45 years of age.
-
Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion
activities (example: sitting or bending over a shopping cart)
-
Subjects who have been symptomatic and undergoing conservative care treatment for at
least 6 months.
-
Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal).
-
Must be able to sit for 50 minutes without pain and to walk 50 feet or more
-
Subjects who are able to give voluntary, written informed consent to participate in this
clinical investigation and from whom consent has been obtained.
Exclusion Criteria:
-
Axial back pain only
-
Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or
surgical intervention other than those required to implant the control or investigational device
-
Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
-
Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1-4)
-
Spondylolysis (pars fracture)
-
Degenerative lumbar scoliosis with a Cobb angle of > 10° at treatment level
-
Osteopenia or osteoporosis. To confirm eligibility, at the Clinical Investigator’s discretion
-
Insulin-dependent diabetes mellitus
-
Prior surgery of the lumbar spine
-
Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)
-
Active systemic disease such as AIDS, HIV, hepatitis, etc.
-
Tumor in the spine or a malignant tumor except for basal cell carcinoma
-
Known or suspected history of alcohol and/or drug abuse
Additional Questions on Trial Participation:
For additional information on this trial, contact Nicole Blackwell at either (310) 574-0414 or nblackwell@discmdgroup.com.
[Top]
Quick Links: Home | About Dr. John Regan, Los Angeles Spine Surgeon | Contact Information for Los Angeles locations | Appointment Scheduling | Get a Second Opinion | Spine Conditions | Spine Treatment Options: Nonsurgical Spine Care, Spine Surgery including surgery for Cervical, Lumbar and Thoracic Disc Herniation, Minimally Invasive Spine Surgery, Lateral Access Surgery, Anatomic Facet Replacement System | Clinical Trials | Patient Center | Educational Resources | For Physicians | Appointment Scheduling for Dr. John Regan, Spine Surgeon in Los Angeles, CA
Educational illustrations and content Copyright © 2011 Prizm Development, Inc.
Web Site Design by Prizm Development, Inc.,
the most experienced developer of spine centers of excellence.
www.prizmdevelopment.com
|
|
Welcome to John J. Regan, MD
Click here to listen to a message from Dr.
John Regan about finding freedom from back pain.
Recognize emergency symptoms
for back and neck pain
Do you have weakness or numbness in a hand or foot?
Are you unable to raise your toe as you walk?
Do you have any loss of bowel or bladder control?
If you answered yes to any of these questions, click here. |
