Regenn® Therapy System Safety Study

Inclusion criteria

(must meet ALL):

• Subject has provided written informed consent on a form reviewed and approved by the Institutional Review Board for the clinical site.
• The subject is 18 - 80 years old.
• The subject has Spondylolisthesis of Meyerding Grade II or less, or has Degenerative Disc Disease (DDD) accompanied by back pain with or without leg pain at a level between L1 and S1 confirmed by history and radiographic assessment. DDD is determined to be present if one or more of the following are noted:

• Instability (defined as angulation ≥ 5 degrees and/or translation ≥ 3mm on flexion/extension radiographs;
• Osteophyte formation of facet joints or vertebral endplates;
• Decreased disc height, on average by >2mm, but dependent upon the spinal level;
• Scarring / thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;
• Herniated nucleus pulposus;
• Facet joint degeneration / changes; and/or
• Vacuum phenomenon.
• Female subjects of childbearing potential must not be pregnant or nursing and must agree to use of contraception for the study duration. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test and birth control.
• The subject is willing and able to comply with the protocol mandated follow-up visits and testing regimen.

Exclusion criteria

(candidates meeting ANY of the following at the time of the study procedure are NOT eligible):

• Subject is unable or unwilling to provide informed consent or is unable to conform to the study protocol follow-up procedures and visits.
• Subject has a contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, bone allograft, or blood transfusion that is not amenable to pretreatment with steroids or/and antihistamines.
• Subject has a history of bleeding diatheses or coagulopathy.
• Subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or any autoimmune diseases.
• Subject is receiving dialysis or immunosuppressive therapy.
• Subject suffered a hemorrhagic stroke < 6 months prior to the study procedure.
• Subject is undergoing spinal surgery for vertebral fracture, trauma, or scoliosis.
• Subject has any form of active malignancy.
• Subject is an intravenous drug user and/or alcoholic.
• Subject is diagnosed with septicemia at the time of the study procedure.
• Subject is a smoker.
• Subject has Type I diabetes.
• Subject has overt, uncontrolled Type II diabetes.
• Subject has a condition requiring postoperative medications that would be expected to interfere with fusion (e.g., steroids), or has received drugs that interfere with bone metabolism within 2 weeks of the surgery.
• Subject is suffering from gross obesity, defined as > 40% IBW.
• Subject exhibits Waddell signs of Inorganic Behavior ≥ 3.
• Subject has had a previous, anterior spinal fusion, interbody spinal fusion, or posterior spinal instrumentation at the involved level.
• Subject has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years.
• Subject has a systemic disease of connective tissue such as Rheumatoid Arthritis, or Ankylosing Spondylitis.
• Subject is a prisoner.
• Subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).