Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions

The post marketing clinical trial is designed to assess lumbar fusion using interbody cages
with autograft in conjunction with instrumented posterolateral gutter fusions using nanOss
Bioactive bone void filler in patients with degenerative disc disease (DDD) characterized by
the inclusion and exclusion criteria listed below.

Patients for this study will be recruited from up to 10 clinical sites. It is estimated that
100 patients will be enrolled in the study. At least 10 investigators will participate in the
study. Patients who meet the inclusion and exclusion criteria will be asked to sign the
informed consent. Preoperatively, the patient will provide his /her medical history and
complete self assessment forms. The investigator will perform a clinical evaluation.

Patients who meet the criteria for entrance into the study will undergo lumbar fusion using
interbody cages with autograft in conjunction with instrumented posterolateral gutter fusions
using nanOss Bioactive in combination with local autograft and bone marrow aspirate (BMA).
Anterior lumbar interbody fusion procedures are not allowed.

Following surgery, operative and discharge information will be collected. The patients will
be evaluated at 6 weeks, 6 months and 12 months postoperatively. At each postoperative visit,
the investigator will clinically evaluate the patient and the patient will complete self
assessment documents, Oswestry Disability Index, Quality of Life questionnaires and a surgery
satisfaction survey, e.g., very satisfied, satisfied, somewhat unsatisfied, or very
unsatisfied with the surgery. Fusion status will be evaluated radiographically at each visit
using plain films. CT scans at 12 months will be evaluated by an independent radiologist.
Complication data will be recorded throughout the study.

Inclusion Criteria:

The patient can be included in the study if all of the following criteria are met;

1. is at least 18 years of age and skeletally mature

2. must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc
disease (DDD) at one or two adjacent levels from L2-S1 requiring a fusion

3. must have completed a minimum of three months of unsuccessful conservative,
non-operative care

4. must have discogenic back pain with or without leg pain

5. DDD must be confirmed by MRI or CT scans followed by discography (if necessary)

6. must score at least 40 points on the Oswestry Disability Index

7. must score at least a 4 on a 10 cm Visual Analog Scale for back pain

8. must be able to comply with the protocol‟s follow-up schedule

9. must understand and sign the informed consent document

Exclusion Criteria:

The patient must not exhibit any of the following criteria;

1. symptomatic at more than two levels

2. previous fusion surgery at any lumbar level with or without instrumentation (prior
discectomy, laminotomy, laminectomy or nucleolysis at the operative (involved) level >
6 months is permitted)

3. more than 50% spondylolisthesis

4. lumbar scoliosis greater than 11 degrees

5. osteoporosis*, osteopenia, osteomalacia, Paget‟s disease or metabolic bone disease.

6. spinal tumors

7. active arachnoiditis Pioneer Surgical Technology Confidential nanOss Bioactive Post
Marketing Clinical Study: March 11, 2010 Page 8

8. fractures of the epiphyseal plate or fractures for which stabilization of the fracture
is not possible.

9. Impaired calcium metabolism

10. active infection or surgical site infection

11. rheumatoid arthritis or other autoimmune disease

12. chronic steroid use (used steroids for one month within the last 6 months) or any
medical condition that requires treatment with drugs known to interfere with bone
healing

13. systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis

14. morbid obesity defined as body mass index (BMI) >40 or a weight more than 100 lbs over
ideal body weight

15. smokers unless the patient agrees to quit at least 2 weeks prior to and for the
duration of the study, confirmed by a carboxyhemoglobin test prior to surgery

16. psychosocial disorders that would preclude accurate evaluation or has a history of
substance abuse

17. active malignancy except non-melanoma skin cancer; history of any invasive malignancy
unless treated and in remission for at least five years

18. documented allergies to porcine collagen or titanium

19. pregnancy, or interested in becoming pregnant in the next four years

20. participation in another investigational study within 30 days *Osteoporosis will be
assessed at the time of the preoperative evaluation based on the patient‟s history,
physical examination and review of the radiographic evaluations. All patients at risk
for osteoporosis must obtain a DEXA scan of the spine and hip to determine if the
patient has severe osteoporosis. The definition of a patient at risk used by the
National Osteoporosis Foundation includes the following: i. Premature menopause (< 45
years) ii. Prolonged amenorrhea (> one year) iii. Maternal history of hip fracture iv.
Primary hyperparathyroidism or hyperthyroidism v. Chronic renal failure vi. Previous
fragility fractures, particularly of the hip, spine or wrist vii. Patients who have
ever taken corticosteroids in doses >7.5 mg/day for one year or more. Patients will be
excluded if their bone mineral density (BMD) in the spine or hip is more than 1.0
standard deviation (SD) below the mean of normal adults in the presence of one or more
fragility fractures indicating severe osteoporosis. If severe osteoporosis is
diagnosed, the patient must be excluded from the investigational study. If the patient
has osteoporosis or osteopenia, they may be included in the study if he or she meets
the rest of the inclusion and exclusion criteria.