Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease (FLD)

January 18, 2018 updated by: AxioMed Spine Corporation

An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

This study will look at the result of using the FLD device as an artificial lumbar disc. The study will compare the safety and effectiveness of the FLD artificial lumbar disc to an already approved artificial lumbar disc.

Study Overview

Status

Status

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

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 Freedom Lumbar Disc is indicated for spinal arthroplasty in skeletally mature patients with single level, symptomatic degenerative disc disease (DDD) from L3-S1. This is a prospective, multi-center, randomized, controlled trial. Subjects with DDD will be randomized to disc arthroplasty with the FLD device or a control device. The overall purpose (objective) of this trial is to collect clinical data to demonstrate the safety and effectiveness of FLD used for the treatment of symptomatic lumbar degenerative disc disease compared to the control device.

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 (Anticipated)

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.
300

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

  • Germany
      • Berlin, Germany, 14050
        • Westend Hospital
      • Gorlitz, Germany, 02828
        • Klinikum-Goerlitz
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • San Diego, California, United States, 92024
        • CORE Orthopaedic Medical Center
    • Colorado
      • Loveland, Colorado, United States, 80538
        • The Spine Institute
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Resurgens Spine Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Spine Institute of Louisiana
    • Nebraska
      • Omaha, Nebraska, United States, 68154
        • Nebraska Spine Center, LLC
    • New York
      • New York, New York, United States, 10003
        • NYU/Hospital for Joint Diseases
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolina NeuroSurgery & Spine Associates
      • Durham, North Carolina, United States, 27704
        • Triangle Orthopaedic Associates, P.A.
    • Texas
      • Austin, Texas, United States, 78731
        • Central Texas Spine Institute
      • Plano, Texas, United States, 76208
        • Texas Back Institute
      • Tyler, Texas, United States, 75701
        • Gordon Spine & Brain Associates

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

17 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single level, degenerative disc disease at L3 to S1, inclusive.
  • Minimum of 6 months of unsuccessful conservative treatment.
  • Subject is a surgical candidate for an anterior approach to the lumbar spine (<3 abdominal surgeries).
  • Back pain at the operative level only (by discogram, if necessary).
  • Leg pain and/or back pain due to disc space settling, with or without radicular symptoms related to foraminal narrowing.
  • Subject must understand and sign the written Informed Consent.

Exclusion Criteria:

  • Prior fusion at any lumbar level.
  • Clinical evidence of adjacent lumbar segment disease.
  • Previous trauma to the L3, L4, L5, or S1 levels (in compression or burst).
  • Non-contained or extruded herniated nucleus pulposus.
  • Congenital stenosis or central/lateral stenosis (mid-sagittal stenosis of <8mm by CT or MR) secondary to acquired degenerative disease requiring treatment that destabilizes the spine (requiring fusion), or for subjects in whom increased motion may increase symptoms.
  • Retro- or spondylolisthesis of ≥ 2.5 mm which is either fixed or present on flexion/extension films, and slippage of vertebral body where the listhesis is due to disc space settling in the absence of degenerative facets or a pars interarticularis defect.
  • Significant kyphosis (>11ْ sagittal plane deformity).
  • History of any invasive malignancy (except non-melanoma skin cancer) unless treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years (in particular, spinal tumors).
  • Acute or chronic infection (local or systemic).
  • Instability or facet joint arthrosis, clinically significant.
  • Arachnoiditis.
  • Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
  • Radiographic findings of a fused or total collapsed disc.
  • Subject using medications or drugs known to potentially interfere with bone or soft tissue healing (high-dose of steroids, osteoclast inhibitors, etc.).
  • Systemic disease affecting the spine, including rheumatoid arthritis, autoimmune disease, AIDS, HIV, or hepatitis.
  • Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed separately).
  • Psychosocial disorders (e.g. evidence or drug or alcohol abuse).
  • Morbid (extreme) obesity (BMI ≥ 40 kg/m2).
  • Bone growth stimulator use in spine.
  • Investigational drug or device use within 30 days.
  • Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan if poor bone quality is suspected (T-score < -1.0).
  • If female of childbearing potential, pregnant or interested in becoming pregnant in the next three years.
  • Type 1 diabetes, and uncontrolled (or poorly controlled) Type 2 diabetes.
  • Subjects with a history of implant rejection.
  • Provocative discography with non-concordant pain at the operative level.
  • Incarcerated subjects.
  • Myelopathy.
  • Significant leg pain of a radicular or neurogenic claudication nature.
  • Involved vertebral endplates dimensionally smaller then 39 mm in the mediallateral and/or 32 mm in the anterior-posterior directions.
  • Subjects not able to meet follow-up requirements.
  • Lumbar scoliosis > 11 degrees.
  • Any previous or current litigation related to the spine.

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 Assignment
  • Masking: None (Open Label)

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.
Active Comparator: Control
Device: Control
Artificial lumbar disc
Experimental: Treatment
FLD
Device: FLD
Artificial lumbar disc

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
Overall success will be determined by a composite of measures regarding subject self-assessment of function (disability), low back pain, neurological function and device implantation status.
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
The improvement of subject self-assessment of function (disability), low back pain, patient satisfaction, neurological function and device implantation status at the 24 month follow-up compared to baseline.
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.
AxioMed Spine Corporation

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.
September 1, 2008

Primary Completion (Anticipated)

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.
July 1, 2018

Study Completion (Anticipated)

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.
July 1, 2018

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).
October 13, 2008

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.
October 17, 2008

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.
October 20, 2008

Study Record Updates

Last Update Posted (Actual)

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.
January 23, 2018

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.
January 18, 2018

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.
January 1, 2018

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.
  • PR-125

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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