The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a tissue barrier when used as an annular patch in discectomy patients with low back & leg pain when compared to traditional discectomy patient outcomes. This will be a 120 patient, prospective randomized study model over a 5 year post-operative period.

Inclusion Criteria:

• Patients between 18 and 90 years of age
• Patient is able to understand the aims and objectives of the trial and the trial procedures
• Patient is willing to give written informed consent to the trial
• Patient is able to follow up with regularly scheduled visits with and phone calls from Dr. Anderson and his research staff
• Diagnosed with lumbar protruding disc
• Suffer from radiating leg pain and low back pain that has failed a minimum of 6 months of conservative (non-operative) treatment options

Exclusion Criteria:

• Participation in clinical trial involving therapy for back pain within 30 days of screening
• Prior back surgery at the same level
• Inability to walk independently (adaptive devices such as walkers or canes are allowed)
• Relation (whether direct or indirect) to, student of, employee of, colleague of, indebted to the primary investigator, host institution or sponsoring company
• Receipt of corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within 1 month prior to visit
• Pregnancy or planning to become pregnant during study period
• Body Mass Index >50
• Patients with chronic diseases such as Crohn's disease, severe renal failure (serum creatinine 2.5 mg/dL or subject on hemodialysis), severe hepatic insufficiency: known cirrhosis, any degree of ascites, serum transaminases more than 3 times the upper limit of normal, life expectancy of less than one year, uncompensated or uncontrolled right sided heart failure with associated edema
• Severe anemia, hemoglobin <8.5 mg/dL
• Active, local or systemic malignancy such as lung cancer or leukemia
• Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 100 mmHg)
• Severe hypoxia, with chronic oxygen or ventilation therapy
• History of collagen vascular disease or sickle cell anemia
• Active rheumatoid arthritis
• Systemic antibiotic therapy for any indication within 10 days of screening