A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

Inclusion Criteria:

- The patient has failed conservative treatment and is a candidate for spinal fusion
surgery.

- The patient is ≥18 years old and of legal age of consent.

- The patient is, in the investigator's opinion, psychosocially, mentally, and
physically able to fully comply with this protocol, including the post-operative
regimen, required follow-up visits, the filling out of required forms, and have the
ability to understand and give written informed consent.

- The patient is skeletally mature (epiphyses closed).

- The patient has signed the IRB approved informed consent.

- The patient is willing and able to participate in post-operative clinical and
radiographic follow up evaluations for 2 years.

Exclusion Criteria:

- Patient has systemic infection or infection at the surgical site.

- Patient has a medical condition that would interfere with post-operative assessments
and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia,
etc.).

- Patient is in poor general health or any concurrent disease process that would place
the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary
problems, or cardiac disease).

- Patient has a history (present or past) of substance abuse (recreational drugs,
prescription drugs or alcohol) that in the investigator's opinion may interfere with
protocol assessments and/or with the patient's ability to complete the protocol
required follow-up.

- The patient is pregnant/breastfeeding at the time of enrollment, or plans to become
pregnant during the course of the study.

- Patient is participating in another investigational study, which could confound
results.