Restore CLINICAL TRIAL

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Spinal Kinetics
Sponsor:
Information provided by (Responsible Party):
Spinal Kinetics
ClinicalTrials.gov Identifier:
NCT01609374
First received: May 24, 2012
Last updated: September 4, 2014
Last verified: September 2014
  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.


Condition Intervention Phase
Cervical Radiculopathy
Degenerative Disc Disease
Device: M6-C Artificial Cervical Disc
Device: Anterior plate system with corticocancellous allograft bone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spinal Kinetics:

Primary Outcome Measures:
  • Safety Evaluation through 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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)

  • Effectiveness Evaluation through 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Evaluate the effectiveness using Neck Disability Index (NDI)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Evaluate the Neck and Arm pain VAS, health-related quality of life SF-36, surgery outcomes, patient satisfaction and quantitative and qualitative radiographic assessments


Estimated Enrollment: 243
Study Start Date: April 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609374

Contacts
Contact: Bill Weinandt bweinandt@spinalkinetics.com

Locations
United States, Arizona
Desert Institute for Spine Care Recruiting
Phoenix, Arizona, United States, 85020
Principal Investigator: Christopher Yeung, MD         
United States, California
Lauryssen Neurosurgical Spine Institute Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Carl Lauryssen, MD         
United States, Colorado
Rocky Mountain Associates in Orthopedic Medicine Recruiting
Johnstown, Colorado, United States, 80534
Principal Investigator: Kenneth Pettine, MD         
United States, Illinois
Midwest Orthopaedics at Rush Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Edward Goldberg, MD         
United States, Maryland
Greater Baltimore Neurological Associates Recruiting
Baltimore, Maryland, United States, 21204
Principal Investigator: Reginald Davis, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Principal Investigator: Andrew Sama, MD         
United States, North Carolina
Carolina Neurosurgery and Spine Associates Recruiting
Charlotte, North Carolina, United States, 28204
Principal Investigator: Dom Coric, MD         
Triangle Orthopedic Associates Recruiting
Durham, North Carolina, United States, 27704
Principal Investigator: David Musante, MD         
United States, Tennessee
Center for Sports Medicine and Orthopaedics Recruiting
Chattanooga, Tennessee, United States, 37404
Principal Investigator: Scott Hodges, DO         
United States, Texas
Texas Back Institute Recruiting
Plano, Texas, United States, 75093
Principal Investigator: Scott Blumenthal, MD         
Precision Spine Care Recruiting
Tyler, Texas, United States, 75701
Principal Investigator: Andy Redmond, MD         
Sponsors and Collaborators
Spinal Kinetics
  More Information

Additional Information:
No publications provided

Responsible Party: Spinal Kinetics
ClinicalTrials.gov Identifier: NCT01609374     History of Changes
Other Study ID Numbers: CA-C002
Study First Received: May 24, 2012
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Spinal Kinetics:
Spinal Kinetics
artificial cervical disc
cervical radiculopathy
ACDF
neck pain
cervical spine
degenerative disc disease

Additional relevant MeSH terms:
Radiculopathy
Intervertebral Disc Degeneration
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014