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Desert Institute for Spine Care has enrolled patients in two clinical trials evaluating a new cervical disc replacement option for patients with degenerative cervical disc disease.

The clinical trials are evaluating the BAGUERA® C cervical artificial disc, which is designed to help maintain the natural behavior and mobility of a functional cervical spine. While the BAGUERA C is new in the U.S and only available in these clinical trials, more than 35,000 have been implanted in patients in more than 40 countries outside the U.S. since 2007.

Approximately 5% of people under age 50 have disc degeneration, while 90% of people over age 50 have some level of degenerative disc disease.ⁱ By age 60, most people will have some level of disc degeneration.ⁱⁱ

Unlike spinal disc fusion, a common surgical treatment option, the goal of cervical disc replacement is to help preserve motion of the cervical spine or spinal segment after surgery. This can provide patients with improved quality of life after treatment.

Patients who have been recruited for clinical trials include people who suffer from symptomatic cervical disc disease affecting one level or two adjacent levels between C3 and C7, and who experience the following signs and symptoms:

• Neck or arm pain, and/or
• Functional and/or neurological deficit accompanied by at least one of the following conditions confirmed by MRI or X-Ray:
  • Herniated nucleus pulposus; and/ or
  • Spondylarthrosis defined by the presence of osteophytes; and/ or
  • Reduction of disc height
  • No response to non-surgical treatment for a period of at least six weeks, or symptoms or signs of progressive root compression despite conservative treatment.
  • Age between 22 to 69

  For more information on the clinical trial, please contact the Desert Institute for Spine Care study coordinator, Jennifer Camoriano, Clinical Research Coordinator, at jennifer@jehnresearch.com or call (480) 695-0681. This study is no longer recruiting patients.

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ⁱ Teraguchi M, Yoshimura N, Hashizume H, et al. Prevalence and distribution of intervertebral disc degeneration over the entire spine in a population-based cohort: the Wakayama Spine Study. Osteoarthr Cartil. 2014;22(1):104-10.

ⁱⁱ Cedars Sinai, Degenerative Disc Disease.  https://www.cedars-sinai.org/health-library/diseases-and-conditions/d/degenerative-disc-disease.html 

Status: This trial has been completed.

Introduction

DISC is one of 12 sites in US, only in AZ where patients have access to the M6-C Artificial Disc: FDA IDE Pivotal Study.  If you are a patient who is interested in participating in this study, please contact DISC directly.

Study Objective

The primary objective is to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc in patients with symptomatic cervical radiculopathy with or without cord compression.

The Study is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy. A total of 243 subjects will be treated; 162 M6-C subjects from up to 15 clinical sites, and 81 ACDF subjects at up to 5 clinical sites. The minimum required post-operative clinical evaluations of subjects will be conducted at 6 weeks, 3 months, 6 months, 1 year and 2 years. Evaluations beyond 2 years may be requested.

Who Will Qualify?

Patients eligible for the study will have a diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgery at one level from C3 to C7, demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies. Patients will have not adequately responded to conservative medical care over a period of at least six weeks. Patients must also be available for regular, scheduled follow-up visits by their treating physician for a minimum of two years post-surgery.

The M6-C Artificial Disc Study is now closed to enrollment due to completion.

Additional Information

More Detail on the Study Protocol

Status: This trial is now full.

Do you have chronic low back pain? Does your low back pain keep you from enjoying everyday life?

Low Back Pain Research Study

Desert Institute for Spine Care is conducting a research study of an investigational, one-hour procedure designed to treat chronic low back pain at its source.

About the Trial

Participants will receive all study-related care at no cost and will be treated by local back pain specialists: Dr. Christopher Yeung, Dr. Anthony Yeung, and Dr. Justin Field.

 

Take the Next Step

To see if this study may be right for you,

Status: The Wallis Stabilization Trial has now been completed.

Desert Institute for Spine Care has been selected to participate in the Wallis Stabilization System Clinical Trial.

Introduction to the Wallis Stabilization System The Wallis Normalization System is a non-fusion, spinal stabilization device that is currently limited by US law to investigational use within the US. The Wallis clinical study is a multi-center, prospective, randomized study comparing the safety and effectiveness of the Wallis device to the latest non-surgical treatment regimen including medication, physical therapy, and spinal injections. The Wallis System is designed to help with the pain caused by degenerative disc disease (DDD) by stabilizing the lumbar spine without a fusion procedure.

Study objectives

The primary objective of the Wallis Clinical Study is to demonstrate that the Wallis System is superior to non-surgical care at treating mild to moderate degenerative disc disease at one or two levels between L1 and L5 of the lumbar spine.

Study overview

Approximately 20 medical centers will be enrolling patients into this clinical study to assess the safety and effectiveness of the Wallis System for mild to moderate degenerative disc disease of the lumbar spine.

The Study will be randomized so that 67% of the study participants will receive a Wallis Device and 33% will receive non-surgical, conservative care treatment which will consist of a balance between medication, physical therapy, and spinal therapy injections. Patients will be randomly assigned to receive either a Wallis Device or conservative care.

Study sponsor

Austin, TX-based Abbott Spine is a wholly-owned subsidiary of Abbott Laboratories. The company researches, develops, and sells spinal instrumentation in the treatment of degenerative spinal disorders.

More Information

Inclusion criteria for Wallis Stabilization System Clinical Trial

• Age 18-60
• Diagnosis of mild to moderate degenerative disc disease, which requires the following:
• Candidate for either surgery with Wallis or aggressive conservative management.
• Patient requires surgical treatment at one or two lumbar levels between L1 and L5.
• Experienced symptoms for at least three months without significant resolution.
• Minimum baseline Oswestry Score of 30% (15/50);
• Physically and mentally able to comply with the protocol, including the ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol; and
• Voluntarily signs the Patient Informed Consent.

Exclusion criteria for Wallis Stabilization System Clinical Trial

• Radiographic evidence of degenerative disc disease at L5-S1;
• Leg pain without back pain;
• Greater than 50% disc collapse as compared to adjacent discs;
• Modic 2 or Modic 3 bone changes at the symptomatic level;
• Radiographic confirmation of severe facet joint disease or degeneration;
• Clinically compromised vertebral bodies at the affected level due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.
• Unwilling to comply with 8 weeks of physical therapy.
• Refusal to consider epidural or facet injections for leg or back pain.
• Active systemic infection or infection at the operative site;
• Osteoporosis.
• Paget’s disease, osteomalacia, or any other metabolic bone disease other than osteoporosis, which is addressed above;
• Rheumatoid arthritis, lupus, or other autoimmune diseases;
• AIDS, HIV, or Hepatitis;
• Known allergy to titanium, polyetheretherketone, or polyester;
• Pathological lesions, such as tumor;
• Congenital lumbar spinal stenosis;
• Cauda Equina syndrome;
• Pregnant at the time of enrollment or with plans to become pregnant within the next three years;
• Concomitant conditions requiring steroid treatment or prior steroid usage for more than one of preceding three months;
• Diabetes mellitus requiring daily insulin management;
• Back or leg pain of unknown etiology;
• Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI >35);
• Fusion previously performed at the same or an adjacent level, or other instrumented spinal surgery at the operative level;
• Prior participation in the study of any experimental spinal implant or treatment;
• Pending litigation relating to spinal injury;
• Life expectancy of fewer than three years;
• History of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for at least 5 years;
• Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention;
• Anticipated or potential relocation >50 miles that may interfere with completion of follow-up examinations;
• Spondylolysis;
• Translation greater than 2 mm at the symptomatic level;
• Significant scoliosis (Cobb angle >25 degrees) or scoliosis otherwise requiring surgical correction;
• Kyphosis requiring surgical correction.

Note: This trial has now been completed.

Desert Institute for Spine Care has been selected to participate in the DASCOR™ disc nucleus replacement pilot clinical study.

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.

Design of the DASCOR™ pilot study

This study is a multicenter, prospective, pilot study in which 20 qualified subjects will be enrolled at up to five investigational sites. Study subjects will undergo surgery to implant the DASCOR™ Disc Arthroplasty device and will be followed postoperatively at predetermined intervals to evaluate safety and effectiveness.

Description of the DASCOR™ Disc Arthroplasty device

The DASCOR™ Disc Arthroplasty device is an in-situ, curable polymer that is designed to replace the degenerated nucleus and restore the disc function in subjects with single-level DDD of the lumbar spine from L2 to the sacrum.

The DASCOR™ is a disc nucleus replacement device

The DASCOR™ Disc Arthroplasty System replaces an abnormal disc nucleus with an artificial device that conforms to the disc nucleus space and is designed to perform like a natural healthy nucleus. The DASCOR™ device is different from an entire artificial disc replacement, where the entire spinal disc – not just the nucleus (the inner portion of the disc) – is replaced. Unlike total disc replacement, the DASCOR™ procedure is minimally invasive and preserves the anatomy of the spine.

The following images depict how the DASCOR™ Disc Arthroplasty System works:

STEP 1: The surgeon accesses the spine creating a small entry site into the annulus or outer portion of the disc.

STEP 2: The surgeon uses a series of instruments to perform a Total Nucleus Removal (TNR).

STEP 3: After total nucleus removal, a sizing/diagnostic balloon is inserted into the disc space.

STEP 4: The balloon is filled with contrast solution that allows it to be seen on fluoroscopy. Then images of the balloon are taken to ensure proper positioning and sizing of the final implant. The contrast material and catheter are then removed.

STEP 5: Another catheter with a balloon is inserted into the disc space.

STEP 6: The mixed polymer passes through the catheter, as a liquid, filling the balloon and the disc space. The implant cures to form a firm but pliable implant that conforms to the individual’s anatomy. The polymer forms a single implant that remains in place.

STEP 7: The catheter is then cut off at the edge of the implant and removed. The remaining implant is designed to restore the original disc function and now replaces the diseased nucleus.

To view an animation of the DASCOR™ Disc Arthroplasty System procedure, please visit www.discdyn.com and click on the image of the spine in the center of the page.

Study sponsor: Disc Dynamics, Inc.

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 investigator.
• Subject is between 18 and 70 years old
• Subject has persistent pain and or symptoms despite at least 6 months of non-operative 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 post-operative 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

Sites that are participating in the DASCOR™ pilot study

• Phoenix, Arizona
• Scottsdale, Arizona
• St. Louis Park, Minnesota
• Utica, New York
• Santa Monica, California

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

UPDATE: FDA Approved! 

Dr. Anthony Yeung, Principal Investigator in the study, along with investigators Dr. Christopher Yeung and Dr. Justin Field, participated in this clinical trial that led to this FDA approval. DISC, the only site in Arizona involved in this trial, was in the top 5 sites whose data was used for papers presented to national and international meetings authored by Josh Auerbach.

More Information

Read on PubMed

Status: This trial is now full.

Introduction

The Coflex® Dynamic Interspinous Stabilization Device Clinical Trial is designed to compare the safety and effectiveness of a new way to treat spinal stenosis. This trial is a multi-center, prospective, randomized controlled study that will evaluate the safety and effectiveness of lumbar laminotomy decompression augmented with the implantation of the Coflex® device as compared to the most common treatment of spinal stenosis; lumbar laminotomy decompression, augmented with pedicle screw fixation and fusion.

Study Overview

• Up to twenty-five clinical sites will participate. Total enrollment of 460 or more patients is expected.
• Patients will be randomized to receive either decompression and Coflex® for stabilization, or decompression and pedicle screw fixation and fusion for stabilization.
• Patients will be followed at 6 weeks, 3 months, 6 months, 1 year, 2 years, and annually up to 5 years.

Who qualifies to enroll in this trial?

Before any trial procedures can begin, anyone who participates in this study must properly sign and date the Informed Consent Form (ICF). Your doctor will explain to you the trial procedures and the possible risks and benefits of your participation. As part of the informed consent process, your doctor will also explain to you what personal information of yours is to be collected, including medical records.

Although your doctor can explain the full details, here is a partial list of some of the criteria for participation in this study:

• 40-80 years old
• An appropriate candidate for surgery
• At least moderate lumbar stenosis
• No more than 2 levels should require surgery (those levels must be consecutive)
• No prior lumbar fusion
• No lumbar disc herniation requiring concurrent surgery
• No pregnancy or planned pregnancy
• Must have had at least 6 months prior care and failed non-operative treatment

Why is this trial being conducted?

Over 25,000 people outside the U.S. have been implanted with the coflex® investigational device. An article in the professional journal Medical News Today reports on some of the positive early clinical results for the Coflex® investigational device. These results include:

• Of a group of 200 patients implanted with the Coflex® device in Damp, Germany, 86% reported relief in low back pain that allowed them to significantly increase their walking distance.
• Based on a 12-month follow-up with 46 patients (with an average age of 63) treated with the Coflex® device in Straubing and Bogen, Germany, results showed reduced post-operative disability and pain scores as compared with pre-operative scores

At this time, the sponsor company, Paradigm Spine, LLC, has received approval from the US FDA to conduct this clinical trial in the US. The company is seeking approval to market the Coflex® device in the US after all regulatory requirements have been fulfilled.

To learn more about the Coflex® Study, please use: https://coflexsolution.com/ or contact Jennifer Camoriano, Research Coordinator at: (602) 755-9058 ext. 124.

Status: This trial has been completed.

Introduction

The study is a multi-center, prospective, randomized controlled clinical trial that will compare the safety and effectiveness of the CerviCore™ Intervertebral Disc to anterior cervical discectomy and fusion (ACDF) with a rigid plate for radicular symptoms associated with loss of disc height, disc/osteophyte complex, or herniated disc at a single cervical spine level. The trade name of the investigational device is CerviCore™ Intervertebral Disc.

Study objectives

The objective of this clinical investigation is to compare the safety and effectiveness of the CerviCore™ to ACDF surgery in the treatment of cervical radicular symptoms (upper extremity pain and/or neurological deficit) associated with loss of disc height, disc/osteophyte complex, or herniated disc at a single level between C3 and C7.

Study overview

• Up to twenty-five (25) study centers will participate
• Approximately four hundred (400) patients will enroll in the study
• Patients will be randomized to receive either the CerviCore™ Intervertebral Disc or the control treatment (ACDF)
• Study patients will be followed at 6 weeks, 3 months, 6 months, 12 months 24 months and annually thereafter, as feasible, through post-operative year 5

Study sponsor

• Stryker Spine, Allendale, NJ

Inclusion criteria (key criteria):

• Skeletally mature and between 18 and 65 years of age, inclusively
• Clinically confirmed radicular symptoms in the distribution of a single degenerated disc from C3/4 to C6/7 in either or both of the upper extremities defined by the following complaint(s):
• a. Pain unresponsive to non-operative treatment, AND/OR
• b. Neurological deficit
• Radicular symptoms are consistent with radiographic evidence of single-level nerve root compression (from C3/4 to C6/7) associated with at least one of the following:
  • a. significant loss of disc height as judged by the Investigator on MRI and/or CT as compared to the normal and clinically asymptomatic adjacent levels,
  • b. posterior osteophytes or disc/osteophyte complex or posterior soft disc herniation

  Exclusion criteria (key criteria):

  • Axial neck pain or referred shoulder pain alone (without radicular symptoms)
  • Radicular symptoms in the distribution of more than one cervical nerve root/disc
  • Previous cervical surgery including any discectomy, any anterior cervical fusion, or any posterior cervical fusion or instrumentation. (This is not intended to exclude a patient with a prior laminectomy/laminotomy at a level that is not the target or adjacent level)
  • History of metabolic bone disease
  • Post-menopausal woman with a DEXA scan hip t-score of < -2.5
  • Taking any of the following medications:
    • a. Chronic oral or IV corticosteroid therapy (this is not intended to exclude inhalation medications for asthma),
    • b. Medications known to potentially interfere with bone/soft tissue healing (e.g. methotrexate),
    • c. Medications that increase bone mineral density (e.g. Fosamax®, Didronel®)
  • Diabetes mellitus requiring daily insulin management
  • Has any of the following:
  • a. progressive neuromuscular disease;
  • b. rheumatoid arthritis;
  • c. active malignancy within the last 15 years (unless the malignancy was treated with curative intent and there have been no clinical signs or symptoms for at least 5 years);
  • d. active hepatitis;
  • e. AIDS, ARC, or is HIV positive;
  • f. cervical myelopathy at any cervical level (This is not intended to exclude cervical myelopathy at the level to be treated due to a soft disc herniation within the past 12 months that can be decompressed by an anterior discectomy);
  • >
  • g. syringomyelia at any spinal level;
  • h. any condition that would interfere with patient self-assessment of pain, function or quality of life
  • Pregnant or is considering pregnancy within the next 3 years (excluded due to x-ray requirements)

  Caution: Investigational device limited by United State law to investigational use. If you think you might be a candidate for this clinical trial, contact us for more information or 

  fill out and submit our online forms