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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AxioMed Spine Corporation
ClinicalTrials.gov Identifier:
NCT00775801
First received: October 13, 2008
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Degenerative Disc Disease (DDD)
Device: FLD
Device: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

Resource links provided by NLM:


Further study details as provided by AxioMed Spine Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
FLD
Device: FLD
Artificial lumbar disc
Active Comparator: Control Device: Control
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775801

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

Additional Information:
No publications provided

Responsible Party: AxioMed Spine Corporation
ClinicalTrials.gov Identifier: NCT00775801     History of Changes
Other Study ID Numbers: PR-125
Study First Received: October 13, 2008
Last Updated: May 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 19, 2014