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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
514

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2005

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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