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

This is an interventional treatment trial for Degenerative Disc Disease (DDD) Read More

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.