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Restore CLINICAL TRIAL

Trial ID or NCT#

NCT01609374

Status

NOT RECRUITING

Purpose

This is a 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 symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients. Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7. A total of 243 subjects will be included at up to 20 sites.

Official Title

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 Symptomatic Cervical Radiculopathy

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria:

Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment 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 (e.g. MRI, CT, x-rays, etc.)
Inadequate response to conservative medical care over a period of at least 6 weeks
Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
Neck or arm pain VAS ≥ 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 ≥ 18 years old and ≤ 75 years old

Exclusion Criteria:

More than one cervical level requiring surgery
Previous anterior cervical spine surgery
Axial neck pain as the solitary symptom
Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine
Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels
Symptomatic facet arthrosis
Less than 4º of motion in flexion/extension at the index level
Instability as evidenced by subluxation > 3 mm at the index or adjacent levels as indicated on flexion/extension x-rays
Advanced degenerative changes (e.g., spondylosis) at the index vertebral level as evidenced by bridging osteophytes, central disc height < 4mm and/or < 50% of the adjacent normal intervertebral disc, or kyphotic deformity > 11º on neutral x-rays
Severe cervical myelopathy (i.e., Nurick's Classification > 2)
Active systemic infection or infection at the operative site
Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment
Metabolic bone disease such as osteoporosis that contradicts spinal surgery (for females over 50 and males over 55 years old, or if the score on the Osteoporosis Self-Assessment Test is < 2, a dual energy x-ray absorptiometry [DEXA scan] of the spine is required; if the bone mineral density T-score in the spine is ≤ -2.5 the patient must be excluded)
History of an osteoporotic fracture of the spine, hip or wrist
History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals
Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
Insulin-dependent type 1 or type 2 diabetes
Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
Pregnant, or intend to become pregnant, during the course of the study
Severe obesity (Body Mass Index > 40)
Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
Involved in current or pending spinal litigation where permanent disability benefits are being sought
Incarcerated at the time of study enrollment
Current participation in other investigational study that may impact study outcomes

View All Criteria

Investigator(s)

Lawrence Shuer, MD

Neurosurgeon, Epilepsy neurosurgeon, Spine neurosurgeon, Pain neurosurgeon, Neuro-oncologist

Professor of Neurosurgery at the Stanford University Medical Center

John Ratliff, MD, FACS

Spine neurosurgeon, Stereotactic neurosurgeon, Neuro-oncologist, Peripheral nerve surgeon

Professor of Neurosurgery at the Stanford University Medical Center

CONTACT

Kara Richardson
(650) 736-6171

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