Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)
NCT ID: NCT00292292
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
514 participants
INTERVENTIONAL
2005-01-31
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Kineflex Lumbar Artificial Disc
Treatment arm
Lumbar Artificial Disc
Insertion of the Kineflex Lumbar ArtificialDisc
Charite
Charite Artificial Disc
Insertion of the Charite
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lumbar Artificial Disc
Insertion of the Kineflex Lumbar ArtificialDisc
Charite Artificial Disc
Insertion of the Charite
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have evidence of degenerative disc disease (DDD)
* History of back and/or radicular pain which is severe, ongoing and recurrent
* Minimum 6 month period of prior conservative care
* Moderate Oswestry Disability Index score
* Moderate pain score
* Be likely to return for all follow-up visits
* Be willing and able to provide Informed Consent for study participation.
Exclusion Criteria
* Foot drop
* Previous trauma to the study treatment level with compression or bursting
* Previous retroperitoneal surgery
* Other spinal surgery at affected level except IDET, laminotomy
* Previous thoracic or lumbar fusion
* Documented abnormal abdominal vessel or muscular/fascial pathology or morphology
* Degenerative spondylolisthesis
* Ischemic (spondylolytic) spondylolisthesis
* Spondylitis
* Documented significant spinal, foraminal or lateral stenosis
* Severely reduced disc space height
* Documented presence of free nuclear fragment
* Extensive facet arthritis or degeneration of the facets at any level noted on MRI, CT or X-ray
* Scoliosis of the lumbar spine
* Metabolic bone disease
* Active systemic infection
* Hepatitis
* Active malignancy or history of metastatic malignancy
* Any terminal or autoimmune disease
* Any other disease, condition or surgery which might impair healing
* Recent history of chemical or alcohol dependence
* Current or extended use of any drug known to interfere with bone or soft tissue healing
* Known metal allergy
* Morbid obesity
* Transitional vertebrae at level to be treated that has not clearly fused
* Currently a prisoner
* Currently involved in spinal litigation
* Currently experiencing an episode of major mental illness
* Pregnancy at time of enrollment, since this would contraindicate abdominal surgery
* Participation in another drug, diologic or medical trial within 30 days of study surgery
* Lives more than 300 miles from a study center or participation in any other investigational drug, biologic or medical device study.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SpinalMotion
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fred Geisler, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Monitor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tower Orthopedics and Sports Medicine
Beverly Hills, California, United States
CORE Orthopaedic Medical Center
Encinitas, California, United States
Kaiser Oakland Regional Spine Surgery
Oakland, California, United States
Loma Linda University
San Bernardino, California, United States
University of California San Diego
San Diego, California, United States
UCSF Dept. of Orthopaedic Surgery
San Francisco, California, United States
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, United States
Illinois Neuro-Spine Center
Aurora, Illinois, 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
Sierra Regional Spine Institute
Reno, Nevada, United States
Hamilton Orthopaedic Surgery and Sports Medicine
Hamilton, New York, United States
Buffalo Spine Surgery
Lockport, 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
Texas Back Institute Clinical Research Organization
Plano, Texas, United States
Gordon Spine Associates
Tyler, Texas, United States
Orthopedics International Spine
Kirkland, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
sponsors web site contains animated information regarding disc
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Kineflex
Identifier Type: -
Identifier Source: org_study_id