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

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.

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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
Implant

Device: Artificial disc
Implant

Active Comparator: ACDF Device: Artificial disk
Implant

Device: Artificial disc
Implant




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

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.


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

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 ClinicalTrials.gov identifier (NCT number): NCT00374413


Locations
Show Show 21 study locations
Sponsors and Collaborators
SpinalMotion
Investigators
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Principal Investigator: Fred Geisler, MD Medical Monitor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SpinalMotion
ClinicalTrials.gov Identifier: NCT00374413    
Other Study ID Numbers: Kineflex|C
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: August 2013
Keywords provided by SpinalMotion:
DDD
artificial disc
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases