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TerminatedNCT00292292Updated Sep 13, 2013

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

An interventional study of Lumbar Artificial Disc and Charite Artificial Disc in Degenerative Disc Disease, sponsored by SpinalMotion. Terminated at 21 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-09-13.

Sponsored by SpinalMotion · Not applicable, Interventional, and Treatment

Why this study was terminated
Economic and business reasons
Phase
Not applicable
Study type
Interventional
Enrollment
514
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Degenerative Disc Disease
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In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's enrollment of 514 is above the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

SpinalMotion is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
514 participants (actual)

Study arms

  • Experimental
    Kineflex Lumbar Artificial Disc

    Treatment arm

    Device: Lumbar Artificial Disc

  • Active comparator
    Charite

    Device: Charite Artificial Disc

Interventions

  • DeviceLumbar Artificial Disc

    Insertion of the Kineflex Lumbar ArtificialDisc

    Also known as: Kineflex Disc

  • DeviceCharite Artificial Disc

    Insertion of the Charite

    Also known as: SB Charite

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What researchers measure

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

    Time frame: 24 months

Secondary outcomes

  1. Maintenance or improvement in neurologic status

    Time frame: 24 months

  2. Pain improvement

    Time frame: 24 months

  3. Significant disc height increase

    Time frame: 24 months

  4. No displacement or migration of the device

    Time frame: 24 months

  5. Time to return to work

    Time frame: 24 months

  6. Time to recovery

    Time frame: 24 months

  7. Preservation of at least 4 degrees of motion in flexion/extension

    Time frame: 24 months

07

Study locations

21 sites
  • 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
    Pittsburg, 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
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00292292
Lead sponsor
SpinalMotion
Responsible party
Sponsor
First posted
Feb 15, 2006
Start date
Jan 2005
Primary completion
May 2009
Completion
Aug 2013
Last update
Sep 13, 2013

Study contacts

Fred Geisler, MD
principal investigator · Medical Monitor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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