We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu


The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01609374
Recruitment Status : Unknown
Verified March 2019 by Spinal Kinetics.
Recruitment status was:  Active, not recruiting
First Posted : June 1, 2012
Last Update Posted : September 18, 2019
Information provided by (Responsible Party):
Spinal Kinetics

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Degenerative Disc Disease Device: M6-C Artificial Cervical Disc Device: Anterior plate system with corticocancellous allograft bone Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: non-randomized, concurrent ACDF control
Masking: None (Open Label)
Masking Description: since the study is concurrently controlled, masking is not possible
Primary Purpose: Treatment
Official Title: Prospective, Non-Randomized, 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
Actual Study Start Date : May 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: M6-C Artificial Cervical Disc Device: M6-C Artificial Cervical Disc
Total disc replacement

Active Comparator: Anterior Cervical Discectomy and Fusion Device: Anterior plate system with corticocancellous allograft bone
Cervical fusion

Primary Outcome Measures :
  1. Safety Evaluation through 24 months [ Time Frame: 24 months ]
    Evaluate the safety by assessing adverse events and neurological function following implantation with the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)

  2. Effectiveness Evaluation through 24 months [ Time Frame: 24 months ]
    Evaluate the effectiveness using Neck Disability Index (NDI)

Secondary Outcome Measures :
  1. Effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) [ Time Frame: 6 weeks, 3 months, 6 months, 12 months, 24 months ]
    Evaluate the Neck and Arm pain VAS, health-related quality of life SF-36, surgery outcomes, patient satisfaction and quantitative and qualitative radiographic assessments

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

All study subjects must present with degenerative cervical radiculopathy with or without spinal cord compression, confirmed clinically and radiologically, requiring surgical intervention at a single vertebral level from C3 to C7.

Inclusion Criteria:

  1. 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.)
  2. Inadequate response to conservative medical care over a period of at least 6 weeks
  3. Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
  4. Neck or arm pain VAS ≥ 4 on a scale of 0 to 10
  5. Willing and able to comply with the requirements of the protocol including follow-up requirements
  6. Willing and able to sign a study specific informed consent
  7. Skeletally mature and ≥ 18 years old and ≤ 75 years old

Exclusion Criteria:

  1. More than one cervical level requiring surgery
  2. Previous anterior cervical spine surgery
  3. Axial neck pain as the solitary symptom
  4. Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine
  5. Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels
  6. Symptomatic facet arthrosis
  7. Less than 4º of motion in flexion/extension at the index level
  8. Instability as evidenced by subluxation > 3 mm at the index or adjacent levels as indicated on flexion/extension x-rays
  9. 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
  10. Severe cervical myelopathy (i.e., Nurick's Classification > 2)
  11. Active systemic infection or infection at the operative site
  12. Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment
  13. 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)
  14. History of an osteoporotic fracture of the spine, hip or wrist
  15. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
  16. Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
  17. Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals
  18. Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
  19. Insulin-dependent type 1 or type 2 diabetes
  20. Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
  21. Pregnant, or intend to become pregnant, during the course of the study
  22. Severe obesity (Body Mass Index > 40)
  23. 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.
  24. Involved in current or pending spinal litigation where permanent disability benefits are being sought
  25. Incarcerated at the time of study enrollment
  26. Current participation in other investigational study that may impact study outcomes
Layout table for additonal information
Responsible Party: Spinal Kinetics
ClinicalTrials.gov Identifier: NCT01609374    
Other Study ID Numbers: CA-C002
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: March 2019
Keywords provided by Spinal Kinetics:
Spinal Kinetics
artificial cervical disc
cervical radiculopathy
neck pain
cervical spine
degenerative disc disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Intervertebral Disc Degeneration
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases