Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)

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. Identifier: NCT00374413
Recruitment Status : Terminated (Economic and business factors)
First Posted : September 11, 2006
Last Update Posted : September 13, 2013
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to show that the Kineflex|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease (DDD) Device: Artificial disk Device: Artificial disc Not Applicable

Detailed Description:
The Kineflex|C disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in two foot print sizes.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Study Protocol for the Investigation of the Kineflex|C Spinal System - a Pivotal Study in Continued Access Stage
Study Start Date : July 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Kineflex-C Device: Artificial disk

Device: Artificial disc

Active Comparator: ACDF Device: Artificial disk

Device: Artificial disc

Primary Outcome Measures :
  1. Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline [ Time Frame: 24 months ]
  2. No major device related adverse events [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline [ Time Frame: 24 months ]
  2. Time to recovery [ Time Frame: 24 months ]
  3. Disc height at 24 months compared to baseline [ Time Frame: 24 months ]
  4. Adjacent level deterioration at 24 months compared to baseline [ Time Frame: 24 months ]
  5. Progressive facet disease at 24 months compared to baseline [ Time Frame: 24months ]
  6. Displacement or migration of the device [ Time Frame: 24 months ]
  7. Odom's Criteria [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • have symptoms of cervical degenerative disc disease (DDD) at only one cervical level from C3 to C7, disc herniation on CT or MRI;
  • have radiculopathy symptoms in neck, one or both shoulders, and/or one or both arms;
  • have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose), the presence of progressive symptoms (e.g., increasing numbness or tingling), or signs of nerve root compression;
  • have moderate disability neck disability index (NDI) score; AND
  • be likely to return for all follow-up visits and be willing and able to provide informed consent for study participation

Exclusion Criteria:

  • marked cervical instability;
  • non discogenic neck pain or non discogenic source of symptoms;
  • radiographic confirmation of severe facet disease or facet degeneration;
  • bridging osteophytes;
  • prior surgery at the level to be treated;
  • prior fusion at any cervical level;
  • more than one neck surgery via anterior approach;
  • previous trauma to the C3-C7 levels resulting in compression or bursting;
  • documented presence of free nuclear fragment at any cervical level;
  • severe myelopathy;
  • any paralysis;
  • history of chemical or alcohol dependence;
  • active systemic infection;
  • infection at the site of surgery;
  • prior disc space infection or osteomyelitis in the cervical spine;
  • any terminal, systemic or autoimmune disease;
  • metabolic bone disease (e.g., osteoporosis, gout, osteomalacia, Paget's disease);
  • any disease, condition or surgery which might impair healing;
  • known metal allergy;
  • arachnoiditis;
  • currently experiencing an episode of major mental illness;
  • pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery;
  • morbid obesity; use of spinal stimulator at any cervical level prior to surgery;
  • currently a prisoner;
  • currently involved in spinal litigation which may influence the subjects reporting of symptoms; OR
  • lives more than 300 miles from study center or participation in any other investigational drug, biologic, or medical device study within the last 30 days prior to study surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00374413

United States, California
Tower Orthopedics and Sports Medicine
Beverly Hills, California, United States, 90211
Kaiser Foundation Research Institute
Oakland, California, United States, 94612
University of California San Diego
San Diego, California, United States, 92103
United States, Colorado
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, United States, 80538
United States, Georgia
Emory Orthopaedics & Spine Center
Atlanta, Georgia, United States, 30329
United States, Louisiana
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
United States, Maryland
Maryland Brain and Spine Center
Annapolis, Maryland, United States, 21401
Orthopaedic Associates, P.A
Towson, Maryland, United States, 21204
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Nevada
Sierra Regional Spine Institute
Reno, Nevada, United States, 89509
United States, New York
Hamilton Orthopaedic Surgery and Sports Medicine
Hamilton, New York, United States, 13346
Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
Manhattan Orthopaedics, P.C.
New York, New York, United States, 10021
United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28207
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, United States, 27704
United States, Pennsylvania
Univ. of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Semmes-Murphy Clinic
Memphis, Tennessee, United States, 38104
United States, Texas
Plano Orthopedic Sports Medicine & Spine Center
Plano, Texas, United States, 75093
SpineMark CRO at Texas Back Institue
Plano, Texas, United States, 75093
Gordon Spine Associates
Tyler, Texas, United States, 75701
United States, Washington
Orthopedics International Spine
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Principal Investigator: Fred Geisler, MD Medical Monitor