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

August 31, 2013 updated by: SpinalMotion

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

514

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Orthopedics and Sports Medicine
      • Encinitas, California, United States, 92024
        • CORE Orthopaedic Medical Center
      • Oakland, California, United States, 94611
        • Kaiser Oakland Regional Spine Surgery
      • San Bernardino, California, United States, 92408
        • Loma Linda University
      • San Diego, California, United States, 92103
        • University of California San Diego
      • San Francisco, California, United States, 94122
        • UCSF Dept. of Orthopaedic Surgery
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Rocky Mountain Associates in Orthopedic Medicine, P.C.
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Illinois Neuro-Spine Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Spine Institute of Louisiana
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Maryland Brain and Spine Center
      • Towson, Maryland, United States, 21204
        • Orthopaedic Associates, P.A
    • Nevada
      • Reno, Nevada, United States, 89509
        • Sierra Regional Spine Institute
    • New York
      • Hamilton, New York, United States, 13346
        • Hamilton Orthopaedic Surgery and Sports Medicine
      • Lockport, New York, United States, 14094
        • Buffalo Spine Surgery
      • New York, New York, United States, 10021
        • Manhattan Orthopaedics, P.C.
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolina Neurosurgery and Spine Associates
      • Durham, North Carolina, United States, 27704
        • Triangle Orthopaedic Associates, P.A.
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15213
        • Univ. of Pittsburgh Medical Center
    • Texas
      • Plano, Texas, United States, 75093
        • Texas Back Institute Clinical Research Organization
      • Tyler, Texas, United States, 75701
        • Gordon Spine Associates
    • Washington
      • Kirkland, Washington, United States, 98034
        • Orthopedics International Spine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Kineflex Lumbar Artificial Disc
Treatment arm
Device: Lumbar Artificial Disc
Insertion of the Kineflex Lumbar ArtificialDisc
Other Names:
  • Kineflex Disc
ACTIVE_COMPARATOR: Charite
Device: Charite Artificial Disc
Insertion of the Charite
Other Names:
  • SB Charite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to recovery
Time Frame: 24 months
24 months
Maintenance or improvement in neurologic status
Time Frame: 24 months
24 months
Pain improvement
Time Frame: 24 months
24 months
Significant disc height increase
Time Frame: 24 months
24 months
No displacement or migration of the device
Time Frame: 24 months
24 months
Time to return to work
Time Frame: 24 months
24 months
Preservation of at least 4 degrees of motion in flexion/extension
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SpinalMotion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

February 13, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (ESTIMATE)

February 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2013

Last Update Submitted That Met QC Criteria

August 31, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kineflex

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe