 CLINICAL TRIALS
Dr. Regan is one of a few selected surgeons who are participating in Food and Drug Administration clinical trials for artificial cervical disc replacement, including: the Anatomic Facet Replacement System (AFRS™), the PRESTIGE® LP Cervical Disc and the PCM cervical artificial disc. Dr. Regan is also participating in the Wallis Stabilization System trial for degenerative disc disease.
Disc Dynamics DASCOR™ Disc Arthroplasty System in the Treatment of Degenerative Disc Disease, PRESTIGE LP Cervical Disc, PCM cervical artificial disc and Wallis Stabilization System 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 Liz Homsher at either (310) 385-8015 or rescoordinator@spinesource.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
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
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.
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.
Who is a Candidate?
- Be between the ages of 21 and 75
- 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.
Who is Not a Candidate?
- 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.
- 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.
Additional Questions on Trial Participation
For additional information on this trial, contact Liz Homsher at either
(310) 385-8015 or rescoordinator@spinesource.com.
PRESTIGE® LP Cervical Disc Clinical Trial
The most common cause of pain results from degenerative conditions of the spine, which occur naturally with age. Degenerative changes cause spinal structures to harden, thicken, dehydrate, expand, and lose elasticity. These changes reduce flexibility and functionality, and the spine becomes less able to tolerate loads and is more susceptible to injury.
The PRESTIGE LP Cervical Disc was studied in early 2005 for use in one level of the cervical spine (neck). This clinical trial will examine the use of the PRESTIGE LP Cervical Disc at two vertebral levels.
The Procedure
The PRESTIGE LP Cervical Disc is a titanium ceramic composite device with two articulating components (ball on top and trough on the bottom) that are attached to the vertebral bodies. This unique ball and trough is designed to provide for replication of normal physiological motion. Dual stabilization rails and a plasma spray coating on each component are intended to help encourage biologic fixation and long-term stability.
The PRESTIGE LP Cervical Disc is available in a variety of sizes to allow the surgeon to closely match the patient’s anatomy.
The PRESTIGE LP Cervical Disc is designed to treat degenerative disc disease at two vertebral levels and allow more natural motion and activities while reducing or eliminating the symptoms without fusing the vertebrae.
Who is a Candidate?
To satisfy some of the criteria for participation in the PRESTIGE LP Cervical Disc clinical trial, you must:
- Be at least 18 years of age
- Be diagnosed with cervical degenerative disc disease
- Be nonresponsive to non-operative treatment for a period of 6 weeks.
- Meet the following conditions as documented by CT, MRI, or plain x-rays: radiculopathy and/or myelopathy with the presence of disc herniation and/or osteophytes
- Require treatment at only two adjacent cervical levels
- Not be pregnant at the time of surgery
- Be able to return for study follow-up appointments for at least two years following surgery.
Who is Not a Candidate?
- Patients who have had previous surgical intervention at either one or both of the involved levels or at adjacent levels.
- Patients with insulin dependent diabetes.
- Patients who have been diagnosed with osteopenia or osteomalacia.
- Patients who have more than two cervical levels that require surgical treatment.
Additional Questions on Trial Participation
For additional information on this trial, contact Liz Homsher at either (310) 385-8015 or rescoordinator@spinesource.com.
PCM Cervical Artificial Disc Clinical Trial
Degenerative disease of the cervical spine is treated using various treatments such as conservative therapy (rest, heat, physical therapy, electrotherapy, medications, etc.) and surgery.
When conservative therapies fail to alleviate the pain and neurological problems caused by degenerative disc disease, the most common treatment is surgical decompression of the affected nerves and spinal cord. This is often accomplished through partial discectomy (foraminotomy) or anterior cervical discectomy and fusion.
In a partial discectomy, the herniation (the bulge) that is pressing against the spinal cord or nerve roots is removed. In addition, part of the degenerated disc is sometimes removed. In anterior cervical discectomy and fusion, the entire disc is removed and bone is grafted between the vertebrae adjacent to the degenerated disc. Discectomies are often successful at decompressing affected structures, however, they can disrupt normal joint motion, reduce the spacing between vertebrae, and reduce the elasticity provided by a normal disc. Anterior cervical discectomy and fusion requires extended immobilization of the neck following surgery and even if the surgery is successful, it results in abnormal stress on adjacent discs of the spine.
The Porous Coated Motion (PCM) cervical artificial disc is designed to preserve flexibility and motion by keeping the normal cervical spacing intact. The PCM cervical disc replacement procedure does not use fusion. The objective of this clinical trial is to evaluate the safety and effectiveness of the PCM cervical artificial disc in comparison to anterior cervical discectomy and fusion.
The Procedure
 The Porous Coated Motion cervical disc replacement procedure has been performed outside the United States since January 2002. To date, more than 1000 procedures have been performed commercially outside the United States with a low incidence of complications.
The PCM cervical artificial disc is composed of two alloy metal endplates, one with a spacer. The endplate surfaces that face the bone have ridges and are coated to enhance post-operative fixation with the bone.
After removal of disc material and bone spurs that might have compressed the nerves, the PCM cervical artificial disc is inserted into the disc space. After precise sizing, the disc is "press fit" to the ends of the vertebra. The porous coated surface allows the bone from the vertebra to grow into the PCM artificial disc, forming a strong bond. The smooth polyethylene spacer glides along the metallic surface allowing motion, which duplicates normal spinal motion. The procedure takes about one hour and the patients can be discharged from the hospital the following morning. Patients must wear a soft collar for one week and they can begin driving within one week. Patients are back to normal clinical function two to three weeks after surgery.
The Porous Coated Motion cervical artificial disc is designed to treat degenerative disc disease and allow more natural motion by reducing or eliminating the symptoms without fusing the vertebrae.
To view a clip of PCM cervical disc replacement surgery, click here.
To view a spine in motion with a PCM cervical disc, click here.
To view a comparison of a spine with a PCM cervical disk and a fused spine, click here.
Who is a Candidate?
To satisfy some of the criteria for participation in the PCM cervical artificial disc clinical trial, you must:
- Be between the ages of 18 and 65 years.
- Have a diagnosis of cervical radiculopathy or myelopathy.
- Have only one level affected between C3-4 and C7-T1.
- Be nonresponsive to more than six weeks of conservative treatment (such as medications, chiropractic, electrical stimulation, etc.).
- Be able to return for study follow-up appointments for at least two years and up to five years.
Who is Not a Candidate?
- Patients with more than one previous cervical surgery, except lamino-foraminotomy at any level or successful single level anterior fusion.
- Patients with cervical multi-level degeneration.
- Patients who have neck pain without arm or leg pain, weakness, or numbness.
- Patients with Diabetes Mellitus who require daily insulin treatment.
Additional Questions on Trial Participation
For additional information on this trial, contact Liz Homsher at either (310) 385-8015 or rescoordinator@spinesource.com.
To review a patient information brochure, click here.
Wallis Stabilization System Clinical Trial
Degenerative disc disease is a common disorder that causes chronic back pain. Currently, only a few surgical procedures are available to relieve the discomfort from chronic back pain. The Wallis Stabilization System is designed to treat this chronic pain by stabilizing the lumbar spine without a spinal fusion procedure.
The primary objective of this clinical trial is to show that the Wallis Stabilization System is superior to non-surgical treatment of mild to moderate degenerative disc disease at one or two levels between lumbar 1 and lumbar 5, excluding lumbar 5 through sacral 1.
The Procedure
A preliminary design of the system was developed in the 1980s, and the current optimized system was developed and has been in use outside the United States since January, 2002. To date, more than 1800 Wallis system procedures have been performed commercially outside the United States with a low incidence of reported complications.
The Wallis system is composed of an interspinous process spacer and stabilizing bands that are passed around adjacent spinous processes. The device is fastened through the wrapping of bands around the bone. Therefore, it does not alter the vertebrae like other procedures that use screws or similar fastening methods. With this procedure, the facet joints and pedicles are not disturbed. The Wallis procedure is viewed as less invasive than other surgical procedures that use instrumentation.
Who is a Candidate?
To satisfy some of the criteria for participation in the Wallis Stabilization System clinical trial, you must:
- Be between the ages of 18 and 60 years.
- Have a diagnosis of degenerative disc disease as confirmed by history and radiographic studies.
- Have one to two spine levels affected between lumbar 1 and lumbar 5, excluding lumbar 5 through sacral 1.
- Have at least three months history of low back pain, which requires surgical treatment.
- Be willing and able to return for study follow-up appointments for at least two years and up to five years.
- Be able to undergo at least four weeks of anti-inflammatories and exposure to physical therapy.
Who is Not a Candidate?
- Patients with greater than 50% disc collapse as compared to adjacent discs.
- Patients with previous thoracic or lumbar fusion, or other spinal, surgery at the affected level.
- Patients who have leg pain without back pain.
- Patients with a history of vertebral fracture.
- Patients with Diabetes Mellitus who require daily insulin treatment.
- Patients with extreme obesity.
- Concomitant conditions requiring steroid treatment or prior steroid usage for more than one of the preceding three months.
- Prior participation in study of any experimental spinal implant or treatment.
- History of any invasive malignancy (except non-melanoma skin cancer), within the last five years.
- Significant scoliosis or scoliosis otherwise requiring surgical correction.
Additional Questions on Trial Participation
For additional information on participating in this trial which will start in November 2006, contact Liz Homsher at either (310) 385-8015 or rescoordinator@spinesource.com.
To review a patient information brochure, click here.
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John
J. Regan, M.D.