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

Stopped early · Not applicable

Conditions studied: Degenerative Disc Disease (DDD)

In brief

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.

Key facts

Study ID

NCT00374413

Run by

SpinalMotion

People needed

343

Starts

2005-07-01

Expected to finish

2013-08-01

Last updated by the study team

2013-09-13

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tower Orthopedics and Sports Medicine — Beverly Hills, California, United States
• Kaiser Foundation Research Institute — Oakland, California, United States
• University of California San Diego — San Diego, California, United States
• Rocky Mountain Associates in Orthopedic Medicine, P.C. — Loveland, Colorado, United States
• Emory Orthopaedics & Spine Center — Atlanta, Georgia, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Maryland Brain and Spine Center — Annapolis, Maryland, United States
• Orthopaedic Associates, P.A — Towson, Maryland, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Sierra Regional Spine Institute — Reno, Nevada, United States
• Hamilton Orthopaedic Surgery and Sports Medicine — Hamilton, New York, United States
• Northern Westchester Hospital — Mount Kisco, New York, United States
• Manhattan Orthopaedics, P.C. — New York, New York, United States
• Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
• Triangle Orthopaedic Associates, P.A. — Durham, North Carolina, United States
• Univ. of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Semmes-Murphy Clinic — Memphis, Tennessee, United States
• Plano Orthopedic Sports Medicine & Spine Center — Plano, Texas, United States
• SpineMark CRO at Texas Back Institue — Plano, Texas, United States
• Gordon Spine Associates — Tyler, Texas, United States
• Orthopedics International Spine — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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