BMAC & Allograft vs BMP-2

Currently, there are many available orthopaedic graft adjuncts which each have their own
advantages and disadvantages. For example, although effective, BMPs are very expensive and
have a risk of side effects. The use of BMAC may be a good alternative to the use of BMPs,
and may not have the same side effects.

Subjects who are scheduled for an elective spinal fusion and are enrolled in the study will
be assigned to receive either BMP or BMAC. Subjects will be asked to complete questionnaires
relating to quality of life, use of pain killers, and overall health, as well as have
standard radiographic studies to examine the spine pre- and post-surgically. Subjects will
attend 7 visits, which happen at the same time as the standard of care visits they would
normally attend for their condition. Subjects will be followed in the study for 2 years in
total.

Inclusion Criteria:

- Must be 18 years old or older

- Scheduled for elective posterior or anterior and posterior spinal fusion of the
thoracolumbar spine with or without anterior interbody support

- Failed at least 6 weeks of conservative care

- No contraindication to BMAC (as per manufacturer)

- Signed consent form

Exclusion criteria:

- Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy
allowed)

- Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars
defect)

- Currently requires laminectomy at level of surgery

- Facet joints at implant level are absent or fractured

- Post-traumatic vertebral body compromise or acute fracture at implant level

- Body mass Index (BMI) > 40

- Known allergy to titanium

- Paget's disease, osteomalacia, or any other metabolic bone disease

- Use of medications or any drug known to potentially interfere with bone/soft tissue
healing (e.g. chronic systemic steroids)

- Unlikely to comply with the follow-up evaluation schedule

- Active malignancy defined as history of invasive malignancy, except if the subject has
received treatment and displayed no clinical signs and symptoms for at least five
years

- Pregnant or planning to become pregnant during the length of study participation