Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

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

Lead Sponsor:

SpinalMotion

Conditions:

Degenerative Disc Disease

Eligibility:

All Genders

18-60 years

Phase:

NA

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.

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 Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2013

    Estimated Enrollment :

    514 Patients enrolled

    Trial Details

    Trial ID

    NCT00292292

    Start Date

    January 1 2005

    End Date

    August 1 2013

    Last Update

    September 13 2013

    Active Locations (21)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (21 locations)

    1

    Tower Orthopedics and Sports Medicine

    Beverly Hills, California, United States, 90211

    2

    CORE Orthopaedic Medical Center

    Encinitas, California, United States, 92024

    3

    Kaiser Oakland Regional Spine Surgery

    Oakland, California, United States, 94611

    4

    Loma Linda University

    San Bernardino, California, United States, 92408