Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT

Inclusion criteria

• Signed Informed Consent Form
• Is at least 18 years of age and skeletally mature.
• Must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1, requiring a fusion.
• Must have completed a minimum of three months of unsuccessful conservative, non-operative care.
• DDD and spinal stenosis and/or spondylolisthesis must be confirmed by MRI or CT scans.
• Must score at least 40 points on the Oswestry Disability Index.
• Must score at least a 4 on a 10 cm Visual Analog Scale for back or leg pain.
• Must be able to comply with the protocol's follow-up schedule.
• Must understand and sign the IRB approved informed consent document.

Exclusion criteria

• Symptomatic at more than two levels.
• Previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the index level (> 6 months) is permitted).
• Previous total disc replacement at any lumbar level.
• Undergoing fusion for recurrent stenosis at the level to be treated.
• Extraspinal cause of back and/or leg pain, or back and/or leg pain of unknown etiology.
• Spondylolisthesis not able to be reduced to grade I.
• Lumbar scoliosis greater than 11 degrees.
• Osteoporosis*, osteopenia, osteomalacia, Paget's disease, or metabolic or systemic bone disorders that affect bone or wound healing.
• Use of posterior instrumentation for stabilization is not possible.
• Intra-operative soft tissue coverage is not possible.
• Spinal tumors.
• Active arachnoiditis.
• Fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
• Impaired calcium metabolism.
• Active systemic infection or surgical site infection.
• Osteomyelitis at the graft site.
• Rheumatoid arthritis or other autoimmune disease.
• Chronic steroid use (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing.
• Systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis.
• Morbid obesity defined as body mass index (BMI) >40 or a weight more than 100 lbs over ideal body weight.
• Smokers unless the subject agrees to quit at least 2 weeks prior to and for the duration of the study, confirmed by a carboxyhemoglobin test prior to surgery.
• Psychosocial disorders that would preclude accurate evaluation or has a history of recent substance abuse.
• Active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years.
• Documented allergies to titanium.
• Subjects with a history of anaphylaxis, history of multiple allergies, known allergies to bovine collagen, or who are being treated for desensitization to meat products because FIBERGRAFT® BG Matrix contains bovine collagen.
• Pregnancy/able to become pregnant and not following a reliable contraceptive method, or interested in becoming pregnant in the next two years.
• Participation in another investigational study within 30 days.
• Prisoners.