Kineflex-C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD) - Full Text View

Sponsored by:	SpinalMotion
Information provided by:	SpinalMotion
ClinicalTrials.gov Identifier:	NCT00374413

Purpose

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	Intervention
Degenerative Disc Disease (DDD)	Device: Artificial disk Device: Artificial disc

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Study Protocol for the Investigation of the Kineflex-C Spinal System - a Pivotal Study

Further study details as provided by SpinalMotion:

Primary Outcome Measures:

Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
No major device related adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Time to recovery [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Disc height at 24 months compared to baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Adjacent level deterioration at 24 months compared to baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Progressive facet disease at 24 months compared to baseline [ Time Frame: 24months ] [ Designated as safety issue: No ]
Displacement or migration of the device [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Odom's Criteria [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	July 2005
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Kineflex-C: Experimental	Device: Artificial disk Implant Device: Artificial disc Implant
ACDF: Active Comparator	Device: Artificial disk Implant Device: Artificial disc Implant

Detailed Description:

The Kineflex 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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374413

Locations

United States, California
Tower Orthopedics and Sports Medicine
Beverly Hills, California, United States, 90211
University of California San Diego
San Diego, California, United States, 92103
Kaiser Oakland
Oakland, California, United States, 94611
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
Manhattan Orthopaedics, P.C.
New York, New York, United States, 10021
Slocum Dickson Medical Group
New Hartford, New York, United States, 13413
Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
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
Pittsburg, Pennsylvania, United States, 15213
United States, Tennessee
Semmes-Murphy Clinic
Memphis, Tennessee, United States, 38104
United States, Texas
Gordon Spine Associates
Tyler, Texas, United States, 75701
Texas Back Institute Clinical Research Organization
Plano, Texas, United States, 75093
Plano Orthopedic Sports Medicine & Spine Center
Plano, Texas, United States, 75093
United States, Washington
Orthopedics International Spine
Kirkland, Washington, United States, 98034

Sponsors and Collaborators

SpinalMotion

Investigators

Principal Investigator:

David Bradford, MD

Medical Monitor

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	SpinalMotion ( VP Regulatory & Clinical Affairs )
Study ID Numbers:	Kineflex-C
Study First Received:	September 7, 2006
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00374413 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by SpinalMotion:

DDD
artificial disc

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

Additional relevant MeSH terms:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009