P-15L Bone Graft Lumbar Fusion Clinical Trial

Inclusion Criteria:

• Skeletally mature adults between 22 and 75 years old (inclusive);

• Back pain with radicular symptoms as evidenced by leg pain, confirmed by history andphysical exam

• Radiographically determined discogenic origin of the pain demonstrating at least oneof the following characteristics: Degenerated/dark disc on MRI, instability (angulation ≥ 5° and/or translation ≥ 3mm on flexion/extension radiographs),osteophyte formation, ligamentous thickening, decreased disc height compared toadjacent levels on radiographic film, CT, or MRI, and disc herniation on CT or MRI

• Oswestry Low Back Pain Disability Questionnaire score of ≥ 35

• Involved disc(s) between L2 and S1

• Planned lumbar fusion at a single level only

• Failed to gain adequate relief from at least 6 months of adequate non-operativetreatment;

• Able and willing to give consent to participate in study;

• Willing and able to participate in the study follow-up according to the protocol;

• Willing and able to comply with postoperative management program;

Exclusion Criteria:

• Systemic infection such as AIDS, HIV, and active hepatitis;

• Autoimmune disease

• Significant metabolic disease that in the surgeon's opinion might compromise bonegrowth such as osteoporosis, osteopenia, or osteomalacia

• Taking medication for the prevention of osteoporosis or other medications that mayinterfere with fusion (e.g. steroids, or has received drugs that interfere with bonemetabolism within 2 weeks of surgery)

• Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk

• Active malignancy

• Nondiscogenic source of symptoms (e.g. tumor, etc.)

• Multiple level symptomatic degenerative disc disease

• Previous spinal instrumentation or a previous interbody fusion procedure at theinvolved level Isthmic Spondylolisthesis

• Spondylolisthesis ≥ grade 2 if present

• Active local or systemic infection

• Known allergy to components within P-15L bone graft including bovine collagen

• PEEK, or materials in supplemental fixation systems

• Pregnant or planning to become pregnant in the next 2 years

• More than one level to be operated

• Has a history of substance abuse (e.g. recreational drugs, alcohol)

• Is a prisoner

• Is currently involved in a study of another investigational product for similarpurpose

• Has a disease process that would preclude accurate evaluation (e.g. neuromusculardisease, significant psychiatric disease);

• Has active or recent (within the past 2 years) Worker's compensation litigation.

• Any condition that would interfere with the subject's ability to comply with the studyrelated requirements.