Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)

This study has been terminated.
(Economic and business reasons)
Sponsor:
Information provided by (Responsible Party):
SpinalMotion
ClinicalTrials.gov Identifier:
NCT00292292
First received: February 13, 2006
Last updated: August 31, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Degenerative Disc Disease
Device: Lumbar Artificial Disc
Device: Charite Artificial Disc

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage

Further study details as provided by SpinalMotion:

Primary Outcome Measures:
  • 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 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maintenance or improvement in neurologic status [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Pain improvement [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Significant disc height increase [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • No displacement or migration of the device [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Time to return to work [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to recovery [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Preservation of at least 4 degrees of motion in flexion/extension [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 514
Study Start Date: January 2005
Study Completion Date: August 2013
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kineflex Lumbar Artificial Disc
Treatment arm
Device: Lumbar Artificial Disc
Insertion of the Kineflex Lumbar ArtificialDisc
Other Name: Kineflex Disc
Active Comparator: Charite Device: Charite Artificial Disc
Insertion of the Charite
Other Name: SB Charite

Detailed Description:

The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 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 Summary:

  • 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.

Exclusion Criteria Summary:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292292

Locations
United States, California
Tower Orthopedics and Sports Medicine
Beverly Hills, California, United States, 90211
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
Kaiser Oakland Regional Spine Surgery
Oakland, California, United States, 94611
Loma Linda University
San Bernardino, California, United States, 92408
University of California San Diego
San Diego, California, United States, 92103
UCSF Dept. of Orthopaedic Surgery
San Francisco, California, United States, 94122
United States, Colorado
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, United States, 80538
United States, Illinois
Illinois Neuro-Spine Center
Aurora, Illinois, United States, 60504
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, Nevada
Sierra Regional Spine Institute
Reno, Nevada, United States, 89509
United States, New York
Hamilton Orthopaedic Surgery and Sports Medicine
Hamilton, New York, United States, 13346
Buffalo Spine Surgery
Lockport, New York, United States, 14094
Manhattan Orthopaedics, P.C.
New York, New York, United States, 10021
United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28204
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, Texas
Texas Back Institute Clinical Research Organization
Plano, Texas, United States, 75093
Gordon Spine Associates
Tyler, Texas, United States, 75701
United States, Washington
Orthopedics International Spine
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
SpinalMotion
Investigators
Principal Investigator: Fred Geisler, MD Medical Monitor
  More Information

Additional Information:
No publications provided

Responsible Party: SpinalMotion
ClinicalTrials.gov Identifier: NCT00292292     History of Changes
Other Study ID Numbers: Kineflex
Study First Received: February 13, 2006
Last Updated: August 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 25, 2014