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Clinical Trials/NCT00292292
NCT00292292TerminatedNot Applicable

Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage

SpinalMotion41 sites in 1 country514 target enrollmentStarted: January 1, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
514
Locations
41
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

  • •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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)
  • Time to recovery(24 months)
  • Preservation of at least 4 degrees of motion in flexion/extension(24 months)

Investigators

Sponsor
SpinalMotion
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (41)

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