Dr. John J. Regan, A Fellowship-Trained Spine Surgeon

John J. Regan, MD
Fellowship-Trained Spine Surgeon

8750 Wilshire Blvd., Suite 350
Beverly Hills, CA 90211

Phone: 310.881.3730
Fax: 310.595.1063
Email: mhosmann@discmdgroup.com

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Clinical Trials

Dr. Regan is one of a few selected surgeons who are participating in Food and Drug Administration clinical trials for artificial disc replacement including the Aesculap Activ-L™ Artificial Disc for the treatment of degenerative disc disease and 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 is also participating in a study of the TOPS™ System to relieve the pain caused by lumbar spinal stenosis

Other clinical trial studies taking place at Dr. Regan's practice include the DuraGen Plus, a device used for the purpose of preventing or minimizing adhesions or scars that may develop after operations on the spine.

Dr. Regan discusses alternative clinical options with a patient experiencing back pain

Disc Dynamics DASCOR™ Disc Arthroplasty System in the Treatment of Degenerative Disc Disease, Activ-L™ artificial disc, the Anatomic Facet Replacement System, the TOPS™ System, and DuraGen Plus clinical trials are described on this page.

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 Madden Hosmann at either (310) 881-3730 or mhosmann@discmdgroup.com.

In the past several years, Dr. Regan participated in a trial for the Dyneses Spinal System (for relief of back and leg pain). For additional information on the Dyneses Spinal System, which has been approved, click here.

A Prospective, Multicenter Pilot Study of the Disc Dynamics DASCOR™ Disc Arthroplasty System in the Treatment of Degenerative Disc Disease

Study objectives for the DASCOR™ Disc Arthroplasty System pilot clinical study

two vertebrae with a disc situated between them This pilot clinical study is designed to evaluate the initial safety and effectiveness of the DASCOR™ Disc Arthroplasty device in subjects with single-level degenerative disc disease (DDD) of the lumbar spine from L2 to the sacrum and to provide data for use in hypothesis and endpoint determination for the pivotal study.

Who can participate in the DASCOR™ pilot study?

Subjects must meet all of the following inclusion criteria and none of the exclusion criteria. A highlight of the criteria are listed below:

Inclusion Criteria

Subject has single-level degenerative disc disease (DDD). For this study, DDD is defined as degeneration of the disc as confirmed by subject history, physical examination, and radiographic studies with one or both of the following factors (as measured radiographically, by Computed Tomography (CT), Magnetic Resonance Imaging (MRI), plain film, myelography, CT discography, etc.):
- Decreased disc height of > 2 mm (subject must have at least 5.5 mm of disc height at the affected level), and/or
- Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
Condition involves only one lumbar spine level from L2 to the sacrum
Subject has a positive CT discogram at the affected level based on the Dallas discogram scale as determined by the investigatoSubject is between 18 and 70 years old
Subject has persistent pain and or symptoms despite at least 6 months of nonoperative care
Subject has an Oswestry score > 40 (based on 100 point scale)
Subject has a back pain score of at least 5 on a 10 point visual analogue scale (VAS)
Subject is able to understand and sign the consent form
Subject is willing and able to comply with the protocol

Exclusion Criteria

Subject has a disc herniation or re-herniation with radicular pain requiring posterior discectomy
Subject has had a prior invasive treatment of the disc at the implant level (e.g. discectomy)
Subject has previous diagnosis of osteopenia or osteoporosis
Subject has had prior lumbar fusion surgery at any level
Subject has a significant medical illness that would pose a risk for surgery (e.g. cardiac, respiratory disease, or Addison’s disease), or that might interfere with postoperative evaluations (e.g. Multiple Sclerosis (MS), Parkinson’s disease, etc.)
Subject has a history of a significant communicable disease (i.e. Human Immunodeficiency Virus (HIV), Hepatitis, etc.) that may increase the risk of surgery
Subject has an active systemic or local infection in the area of the planned surgery
Subject is participating in another investigational drug, device or biologic study
Subject is a prisoner, or alcohol abuser, or substance abuser

Spine Patients interested in participating in the DASCOR™ pilot study

If you are a spine patient who has been diagnosed with degenerative disc disease at one lumbar spine level from L2 to the sacrum, you feel that you may meet the study criteria above, please contact at us at 877-884-7332. Thank you for your interest.

Caution: Investigational Device, Limited by United States Law to Investigational Use.

Anatomic Facet Replacement System Clinical Trial

Dr. Regan performs surgery, with surgical tools in hand

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 Madden Hosmann at either
(310) 385-8015 or mhosmann@discmdgroup.com.

Aesculap Activ-L™ Artificial Disc Clinical Trial

Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease

The purpose of this study is to learn whether an investigational device called the Activ-L™ Artificial Disc is safe and effective in the treatment of degenerative disc disease (DDD) of the lower (lumbar) spine. An investigational device is one that is not approved by the FDA. In this study the Activ-L™ Artificial Disc (investigational treatment) will be compared to the Synthes Spine ProDisc-L Total Disc Replacement that has been approved by the FDA. Your participation is expected to be for a period of 5 years.

Who is candidate?

Subjects between the ages of 18-60
Subjects who have degenerative disc disease, based on the MRI criterias below:

Instability as defined by > 3 mm translation or > 5 degree’s angulation
Osteophyte formation of facet joints or vertebral endplates
Decreased disc height of > 2mm as compared to the adjacent level
Scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule
Herniated nucleas pulposus
Facet joint degeneration/changes
Vacuum phenomenon

Single level DDD at L4/L5 or L5/S1
Have received at least 6 months of non-operative spinal treatment prior to surgery.
Subject has an Oswestry score > 40 (based on 100 point scale)
Back pain at the operative level only, with or without leg pain
Subject has a VAS score > 40 (based on 100 point scale)
Subject is able to understand and sign the consent form
Subject is willing and able to comply with the protocol

Who is not a candidate?

Subject has had a previous surgery at any lumbar level, except IDET, percutaneous nucleoplasty, or microdiscectomy
Subject has a BMI (body mass index) of greater than 35
Subject has previous diagnosis of osteopenia or osteoporosis
Subject has had prior lumbar fusion surgery at any level
Subject has a significant medical illness that would pose a risk for surgery (e.g.
cardiac, respiratory disease, or Addison’s disease), or that might interfere with
postoperative evaluations (e.g. Multiple Sclerosis (MS), Parkinson’s disease, etc.)
Subject has a history of a significant communicable disease (i.e. Human
Immunodeficiency Virus (HIV), Hepatitis, etc.) that may increase the risk of
surgery
Subject has an active systemic or local infection in the area of the planned surgery
Subject is participating in another investigational drug, device or biologic study
Subject is a prisoner, or alcohol abuser, or substance abuser
Subject who has endometriosis, inflammatory bowel disease, Crohn’s disease, diverticulitis, ulcerative colitis, or abdominal adhesions, insulin-dependent diabetes
Subject who is pregnant or planning on becoming pregnant within the next 2 years
Subject who has a history of cancer (except non-melanoma skin cancer) within the last 5 years

Additional Questions on Trial Participation:

For additional information on this trial, contact Madden Hosmann at either
(310) 881-3730 or mhosmann@discmdgroup.com.

The Implant TOPS™ System Clinical Trial

A Prospective, Multi-Center Clinical Study To Assess the Safety and Effectiveness Of The Implant TOPS™ System

This study is designed to test the ability of the TOPS™ System to relieve the pain caused by your spinal condition. The purpose of the study is to compare the results of spinal surgery using the TOPS™ System to the results of spinal fusion. This trial is for patients who have lumbar spinal stenosis at a single level between L3-L5.

Who can participate in the TOPS study?

Subjects must meet all of the following inclusion criteria and none of the exclusion criteria. A highlight of the criteria are listed below:

Inclusion Criteria:

Moderate to sever lumbar spinal stenosis at a single level between L3-L5, with radiographic confirmation of any one of the following on CT, MRI, plain x-ray or myelography:

Evidence of thecal sac and/or cauda equina compression
Evidence of nerve root impingement by either osseous or non-osseous elements
Evidence of hypertrophic facets with canal encroachment

Moderate/severe spinal stenosis is further defined radiographically as;

Moderate canal stenosis is a 25-49% reduction in the A/P dimension of the central and/or lateral foramen when compared to adjacent (cephlad) level
Severe canal stenosis is defined as 50% or greater reduction in the A/P dimension of the central and/or lateral foramen when compared to the adjacent (cephlad) level

*Patients which require minimal decompressive surgery at an adjacent level, may have a laminotomy or soft tissue resection as long as the decompression does not compromise the stability of the adjacent segment.

Subject has persistent pain and or symptoms despite at least 6 months of non-operative care
Age 40-75 years old (male or female)
Up to one prior surgery without instrumentation implanted at any lumbar vertebral level limited to the following: IDET, Laminotomy, Laminectomy, Foraminotomy, and Discectomy (that occurred 3 years ago without any reoccurrence of herniation)
Lower back pain and/or sciatica with or without spinal claudication
Subject has an Oswestry score > 40 (based on 100 point scale)
Subject is willing and able to comply with the protocol
Subject has a back pain score of at least 5 on a 10 point visual analogue scale (VAS)
Subject is able to understand and sign the consent form

Exclusion Criteria:

Subject has previous diagnosis of osteopenia or osteoporosis
Subject has had prior lumbar fusion surgery at any level
Subject has a significant medical illness that would pose a risk for surgery (e.g.
cardiac, respiratory disease, or Addison’s disease), or that might interfere with postoperative evaluations (e.g. Multiple Sclerosis (MS), Parkinson’s disease, etc.)
Subject has a history of a significant communicable disease (i.e. Human
Immunodeficiency Virus (HIV), Hepatitis, etc.) that may increase the risk of surgery
Subject has an active systemic or local infection in the area of the planned surgery
Subject is participating in another investigational drug, device or biologic study
Subject is a prisoner, or alcohol abuser, or substance abuser
Subject has a history of cancer (except non-melanoma skin cancer) within the last 5 years
Subject cannot be pregnant or interested in becoming pregnant in the next 3 years
Subject cannot be an insulin-dependent diabetic

Spine Patients interested in participating in the Implant TOPS™ study

If you are a spine patient who has been diagnosed with lumbar spinal stenosis at one lumbar spine level from L3 to L5, you feel that you may meet the study criteria above, please contact at Madden Hosmann at 310-574-0400 or mhosmann@discmdgroup.com.

DuraGen Plus® Clinical Trial

Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix To Minimize Adhesions Following Lumbar Discectomy

The purpose of this study is to evaluate the effectiveness, safety and performance of the DuraGen Plus. This is a device used for the purpose of preventing or minimizing adhesions or scars that may develop after operations on the spine.

This study is being done because adhesions or scars that form on organs after surgery are common. These adhesions may be responsible for chronic pain and limited movement after lumbar discectomy (surgery to repair a ruptured or slipped disc in your back). This device has been cleared for marketing by the FDA as a dural substitute for the repair of the dura mater (a protective lining of the brain and spinal cord). However, DuraGen Plus is investigational in this study.

Who is a candidate?

Subject must be between the ages of 18-70, male or female
Subjects receiving a microdiscectomy
Subjects that are not pregnant at the time of surgery
Subjects must be able to return for study follow-up appointments for at least one year

Who is not a candidate?

Any subjects that have an active Workman's Compensation claim involving the back or spine
Known allergy to bovine derived products
Subjects that have participated in another clinical trial using an investigational drug or device within the last 30 days
Subject who has HIV or AIDS
Subjects who are insulin-dependent diabetics
Subjects with a BMI (body mass index) greater than 40
Subjects who have a current or planned long-term use of steroids (this inhibits healing)

Additional Questions on Trial Participation:

For additional information on this trial, contact Madden Hosmann at either (310) 881-3730 or mhosmann@discmdgroup.com.

Need more information on back and neck pain?
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News & Media

John J. Regan, MD is now affiliated with D.I.S.C. - Sport and Spine Center:

D.I.S.C., one of the country’s leading spine and sports centers, is redefining patient care. Cited by many as the gold standard in medicine, our world-class facility offers a fully integrated approach to the treatment of skeletal disorders. Click here to learn more.

Television News Feature:
DASCOR™ Disc Arthroplasty System ABC Channel 7 News (7MB Windows Media file)

Television News Feature:
Dr. John Regan Minimally Invasive Procedure for Treatment of Scoliosis (8.1MB Flash Video)

Animated Video:
Spine in motion with the Anatomic Facet Replacement System (1.8MB Windows Media file)

More News & Media