Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease

This is a prospective randomized, non-blinded, controlled study. Patients with a diagnosis of
degenerative disc disease and/or up to grade I spondylolisthesis and planning to undergo a
1-level instrumented posterolateral lumbar fusion surgery between L1-S1 will be screened. If
eligible and the subject meets all the inclusion criteria and none of the exclusion criteria,
the subject will be approached about study participation by the surgeon. If the subject
agrees to participate, the consent process will be initiated by the study coordinator. Once
the patient has been consented; data including medical history, neurological exam, patient
questionnaires (visual analogue pain score (VAS), Oswestry low-back disability questionnaire
(ODI), short form health survey (SF-36)) will be collected. Randomization will occur once a
surgery date has been scheduled so the appropriate instrumentation can be boarded
accordingly. A randomization envelope will reveal randomization treatment group. The
envelopes will be generated in a 1:1 fashion and be randomly allocated to an assigned study
identification number.

Subjects will be randomized to either: 1) treatment arm where the investigator will use an
FDA approved/cleared DePuy Synthes spinal pedicle screw system with ViviGen® Cellular Bone
Matrix mixed with cortical/cancellous allograft or the 2) control arm where the investigator
use the same DePuy Synthes spinal pedicle screw system with local autologous bone graft mixed
with cortical/cancellous allograft. Both treatment groups represent standard of care lumbar
fusion surgeries using two types of bone graft options to create the arthrodesis as
comparators.

Once the lumbar fusion surgery has taken place as planned; data will be collected regarding
the surgery performed, including operative time, amount of bone graft used, spinal system
used, length of hospital stay, and adverse events/complications.

Study subjects will be followed up at 6-weeks, 3-months, 6-months, and 12-months
postoperatively at the private practice or clinic. During these routine (standard of care)
postoperative visits, subjects will complete questionnaires (VAS, ODI, SF-36, patient
satisfaction) and have neurological exam (lumbar spine exam, see appendix 1) completed by the
investigator. Adverse events related to device and/or procedure will be evaluated as each
postoperative visit. Anteroposterior (AP) and lateral x-rays will be performed at all visits
with flexion and extension x-rays added at baseline, 3-months, 6-months, and 12-months. A CT
scan of the lumbar spine will be performed during the 12-month postoperative time frame at
the Beaumont-Royal Oak Imaging Center. Radiographic analysis will be performed and evaluated
for fusion status as evidenced by bony bridging, presence of radiolucency, and development of
pseudoarthrosis at each follow-up visit.

This study design reflects the current standard of care for lumbar spinal stenosis,
degenerative disc disease and lumbar degenerative spondylolisthesis. Lumbar fusion surgery
using pedicle screw fixation with autograft and allograft bone grafting options is treatment
of choice after conservative (non-surgical) therapies have been implemented and failed.

Inclusion Criteria:

1. ≥18 years of age

2. Able to provide consent

3. Is undergoing standard of care one-level instrumented posterolateral fusion at the
level between L1-S1

4. Has diagnosis of spinal stenosis, degenerative disc disease and/or up to Grade 1
spondylolisthesis

5. Requires decompression at intended fusion level (multi-level decompression allowed
L1-S1)

6. Has failed 6-weeks or more of conservative, non-operative treatment

7. Has back and/or radicular lumbar symptoms with ODI score of ≥ 30 preoperatively.

Exclusion Criteria:

1. Any prior lumbar fusion surgery

2. Requires fusion of more than one level

3. Requires an interbody fusion based on relevant diagnoses and factors (such as
foraminal stenosis, degree of spondylolisthesis, spinal deformity, disc space
collapse, and subject's age) as determined by investigator

4. BMI > 40

5. Active systemic infection or infection at operative site

6. History of an osteoporotic fracture and/or vertebral body fracture

7. Is currently being treated with chemotherapy, radiation, immunosuppression or chronic
steroid therapy

8. History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal
surgery

9. Psychological or physical condition in the opinion of the investigator that would
interfere with subject self-assessments

10. History of neurological condition in the opinion of the investigator that may affect
lumbar function and pain assessments

11. Subjects with a history of cancer must be disease free for at least 3 years

12. Pregnant, or plans on becoming pregnant