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.

Dr. Regan discusses alternative clinical options with a patient experiencing back pain, Spine surgeon second opinion beverly hills, Spine surgeon second opinion Newport Beach, Spine surgery second opinion Los Angeles, Second opinion for spine surgery Southern California, Second opinion for back surgery beverly hills, Second opinion for back surgery Newport Beach, Second opinion for back surgery Los Angeles, Spine surgeon beverly hills, Laser spine surgery beverly hills, Laser spine surgery Newport Beach, Minimally invasive spine surgery beverly hills, scoliosis surgery beverly hills, scoliosis surgery Los Angeles, Home remedies for back pain beverly hills, Home remedies for back pain Los Angeles, Home remedy back pain beverly hills, Herniated disc beverly hills, Non-surgical treatement back pain beverly hills, Artificial disc replacement neck beverly hills, Artificial disc replacement back beverly hills, Spine Group Beverly Hills

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 STRiDE, a study evaluating the effectiveness of a decompression using the BAXANO® iO-Flex® System in treating patients with lumbar spinal stenosis and grade I degenerative lumbar spondylolisthesis.

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) 432-1483 or nicole@spinegroupbeverlyhills.com.

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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.

treatment for spinal stenosis los angeles
© ACADIA™ Facet
Replacement System
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.

treatment for spinal stenosis los angeles
© ACADIA™ Facet
Replacement System

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:

Dr. Regan performs surgery, with surgical tools in hand, los angeles spine surgeon, Spine surgeon second opinion beverly hills, Spine surgeon second opinion Newport Beach, Spine surgery second opinion Los Angeles, Second opinion for spine surgery Southern California, Second opinion for back surgery beverly hills, Second opinion for back surgery Newport Beach, Second opinion for back surgery Los Angeles, Spine surgeon beverly hills, Laser spine surgery beverly hills, Laser spine surgery Newport Beach, Minimally invasive spine surgery beverly hills, scoliosis surgery beverly hills, scoliosis surgery Los Angeles, Home remedies for back pain beverly hills, Home remedies for back pain Los Angeles, Home remedy back pain beverly hills, Herniated disc beverly hills, Non-surgical treatement back pain beverly hills, Artificial disc replacement neck beverly hills, Artificial disc replacement back beverly hills, Spine Group Beverly HillsFor additional information on this trial, contact Nicole Blackwell at either (310) 432-1483 or nicole@spinegroupbeverlyhills.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) 432-1483 or nicole@spinegroupbeverlyhills.com.

STRiDE

This study evaluates the effectiveness of decompression using the BAXANO® iO-Flex® System in treating patients with lumbar spinal stenosis and grade I degenerative lumbar spondylolisthesis.

lumbar spinal stenosis los angeles,  degenerative lumbar spondylolisthesis los angeles  

For addtional information on this study, including key inclusion criteria and key exclusion criteria, click here, or select the image to the left.

lumbar spinal stenosis los angeles,  degenerative lumbar spondylolisthesis los angeles   Click here to read about how the iO-Flex® System, a new minimally invasive procedure, can help treat Lumbar Spinal Stenosis. Information provided by iO-Flex® System.

Additional Questions on Trial Participation:

For additional information on this trial, contact Nicole Blackwell at either (310) 432-1483 or nicole@spinegroupbeverlyhills.com

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