Study Stopped
Economic and business reasons
Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)
Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage
1 other identifier
interventional
514
1 country
21
Brief Summary
The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 13, 2006
CompletedFirst Posted
Study publicly available on registry
February 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedSeptember 13, 2013
August 1, 2013
4.3 years
February 13, 2006
August 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in Oswestry Low Back Pain Disability Score at 24 months compared with baseline; no revision removal, supplemental fixation or device related reoperations and no major adverse event as defined by the study protocol
24 months
Secondary Outcomes (7)
Maintenance or improvement in neurologic status
24 months
Pain improvement
24 months
Significant disc height increase
24 months
No displacement or migration of the device
24 months
Time to return to work
24 months
- +2 more secondary outcomes
Study Arms (2)
Kineflex Lumbar Artificial Disc
EXPERIMENTALTreatment arm
Charite
ACTIVE COMPARATORInterventions
Insertion of the Kineflex Lumbar ArtificialDisc
Eligibility Criteria
You may qualify if:
- Be between 18 and 60 years of age
- 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.
You may not qualify if:
- Any back or leg pain of unknown origin
- 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
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SpinalMotionlead
Study Sites (21)
Tower Orthopedics and Sports Medicine
Beverly Hills, California, 90211, United States
CORE Orthopaedic Medical Center
Encinitas, California, 92024, United States
Kaiser Oakland Regional Spine Surgery
Oakland, California, 94611, United States
Loma Linda University
San Bernardino, California, 92408, United States
University of California San Diego
San Diego, California, 92103, United States
UCSF Dept. of Orthopaedic Surgery
San Francisco, California, 94122, United States
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, 80538, United States
Illinois Neuro-Spine Center
Aurora, Illinois, 60504, United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101, United States
Maryland Brain and Spine Center
Annapolis, Maryland, 21401, United States
Orthopaedic Associates, P.A
Towson, Maryland, 21204, United States
Sierra Regional Spine Institute
Reno, Nevada, 89509, United States
Hamilton Orthopaedic Surgery and Sports Medicine
Hamilton, New York, 13346, United States
Buffalo Spine Surgery
Lockport, New York, 14094, United States
Manhattan Orthopaedics, P.C.
New York, New York, 10021, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204, United States
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, 27704, United States
Univ. of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Texas Back Institute Clinical Research Organization
Plano, Texas, 75093, United States
Gordon Spine Associates
Tyler, Texas, 75701, United States
Orthopedics International Spine
Kirkland, Washington, 98034, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fred Geisler, MD
Medical Monitor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2006
First Posted
February 15, 2006
Study Start
January 1, 2005
Primary Completion
May 1, 2009
Study Completion
August 1, 2013
Last Updated
September 13, 2013
Record last verified: 2013-08