P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation

Inclusion Criteria (abbreviated):

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

Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and
physical exam;

Oswestry Low Back Pain Disability Questionnaire score of ≥ 35;

Involved disc(s) between L2 and S1;

Exclusion Criteria (abbreviated):

Significant metabolic disease that in the surgeon's opinion might compromise bone growth
such as osteoporosis, osteopenia, or osteomalacia;

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 the involved
level;

More than one level to be operated;