Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Degenerative Disc Disease (DDD)

Intervention / Treatment
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* Device: FLD
* Device: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>FLD | Device: FLD<br>* Artificial lumbar disc<br>|
| Active Comparator: Control<br> | Device: Control<br>* Artificial lumbar disc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 24 Months |