CLINICAL TRIALS

BAGUERA® C Cervical Artificial Disc Clinical Trial

NSG is now enrolling 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 are candidates for the 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 is 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

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

 

For more information on the clinical trial or eligibility, please contact the NSG study coordinator at 800-899-0101.

Synergy Disc® Cervical Disc Replacement Clinical Study

Do you struggle with pain, numbness or tingling in your neck, shoulder, or arms? It may be due to a damaged cervical disc in your neck – and you have options.

The Spine Surgeons of Neurosurgery & Spine Group are conducting a new clinical study that may be able to help. The study is for the Synergy Disc® – an investigational, artificial cervical disc designed to relieve pain while maintaining motion in the spine.

Cervical degenerative disc disease (DDD) is a condition characterized by degenerated and/or diseased discs leading to nerve root and/or spinal cord compression in the cervical spine. The treatment continuum spans from conservative treatments and therapies to surgical procedures. While less prevalent than low back pain, cervical DDD is equally debilitating and requires careful clinical management to ensure patients return to a normal quality of life.

The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after cervical discectomy to provide restoration of motion and alignment to the functional spinal unit. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a single level discectomy for intractable radiculopathy and/or myelopathy.

To Qualify for the Study, You Must:

• Be between the ages of 18 and 70
• Have been diagnosed with DDD at one level in your neck
• Have not had a fusion surgery at this level before
• Not have osteoporosis or any bone disease (Paget’s, osteomalacia)
• Not have diabetes requiring daily insulin therapy
• Not have had an active cancer within the past 5 years except for skin cancers
• Be willing and able to complete all follow up visits

 

For more information on the clinical trial or eligibility, please contact the NSG study coordinator at 800-899-0101.

M6®-C Artificial Cervical Disc Two-Level IDE Clinical Study

Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.

Patients will be concurrently enrolled in the M6-C treatment group and the ACDF control group. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive symptoms despite continued non-operative treatment. For the study, 263 patients will undergo either a two-level cervical artificial disc procedure or an instrumented (ACDF) procedure as per site group assignment. Patients will be evaluated clinically, radiographically, and via the collection of patient-reported outcomes at 6 Weeks, 3 Months, 6 Months, 12 Months and 24 Months. The primary endpoint is Overall Success at 24 Months.

Inclusion Criteria:

• Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at two contiguous levels 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 (e.g. MRI, CT, x-rays, etc.)
• Inadequate response to conservative medical care over a period of at least 6 weeks or have the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
• Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
• Neck or arm pain Visual Analog Scale Score ≥ 4 on a scale of 0 to 10
• Willing and able to comply with the requirements of the protocol including follow-up requirements
• Willing and able to sign a study specific informed consent
• Skeletally mature and at least 18 years old but not older than 75 years old

 

For more information on the clinical trial or eligibility, please contact the NSG study coordinator at 800-899-0101.