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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00775801
Recruitment Status : Unknown
Verified January 2018 by AxioMed Spine Corporation.
Recruitment status was:  Active, not recruiting
First Posted : October 20, 2008
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
AxioMed Spine Corporation

Tracking Information
First Submitted Date  ICMJE October 13, 2008
First Posted Date  ICMJE October 20, 2008
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
Official Title  ICMJE An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Disc Disease (DDD)
Intervention  ICMJE
  • Device: FLD
    Artificial lumbar disc
  • Device: Control
    Artificial lumbar disc
Study Arms  ICMJE
  • Experimental: Treatment
    FLD
    Intervention: Device: FLD
  • Active Comparator: Control
    Intervention: Device: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 17, 2008)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775801
Other Study ID Numbers  ICMJE PR-125
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AxioMed Spine Corporation
Original Responsible Party Neal Defibaugh, Vice President Clinical and Regulatory Affairs, AxioMed Spine Corporation
Current Study Sponsor  ICMJE AxioMed Spine Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AxioMed Spine Corporation
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP