Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)
NCT ID: NCT00374413
Last Updated: 2013-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
343 participants
INTERVENTIONAL
2005-07-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Kineflex-C
Artificial disk
Implant
Artificial disc
Implant
ACDF
Artificial disk
Implant
Artificial disc
Implant
Interventions
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Artificial disk
Implant
Artificial disc
Implant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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SpinalMotion
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Geisler, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Monitor
Locations
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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
Countries
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References
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Coric D, Guyer RD, Nunley PD, Musante D, Carmody C, Gordon C, Lauryssen C, Boltes MO, Ohnmeiss DD. Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc. J Neurosurg Spine. 2018 Mar;28(3):252-261. doi: 10.3171/2017.5.SPINE16824. Epub 2018 Jan 5.
Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, Lauryssen C, Ohnmeiss DD, Boltes MO. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine. 2011 Oct;15(4):348-58. doi: 10.3171/2011.5.SPINE10769. Epub 2011 Jun 24.
Related Links
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Related Info
Other Identifiers
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Kineflex|C
Identifier Type: -
Identifier Source: org_study_id