Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

Status unconfirmed · Not applicable

Conditions studied: Degenerative Disc Disease (DDD)

In brief

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.

Key facts

Study ID

NCT00775801

Run by

AxioMed Spine Corporation

People needed

300

Starts

2008-09-01

Expected to finish

2018-07-01

Last updated by the study team

2018-01-23

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• CORE Orthopaedic Medical Center — San Diego, California, United States
• The Spine Institute — Loveland, Colorado, United States
• Resurgens Spine Center — Atlanta, Georgia, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Nebraska Spine Center, LLC — Omaha, Nebraska, United States
• NYU/Hospital for Joint Diseases — New York, New York, United States
• Carolina NeuroSurgery & Spine Associates — Charlotte, North Carolina, United States
• Triangle Orthopaedic Associates, P.A. — Durham, North Carolina, United States
• Central Texas Spine Institute — Austin, Texas, United States
• Texas Back Institute — Plano, Texas, United States
• Gordon Spine & Brain Associates — Tyler, Texas, United States
• Westend Hospital — Berlin, Germany
• Klinikum-Goerlitz — Görlitz, Germany

Full record on ClinicalTrials.gov

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