A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion
Conditions: Spondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus, Degenerative Disc Disease
Sponsor: Elutia Inc.

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 1 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
  
 
 
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in 
Cervical and Lumbar Spine Fusion 
 
 
Clinicaltrials.gov Identifier: 
NCT03425682 
 
 
Original Protocol Version Date:  11/17/2017 
 
 
Sponsor: 
Aziyo Biologics, Inc. 
Corporate Headquarters 
12510 Prosperity Drive, Suite 370 
Silver Spring, MD 20904 
 
 
 
Sponsor contact: 
Stephanie Richardson 
678-492-4712 
srichardson@aziyo.com  
 
 
 
 
 
 
 
 
 
 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 2 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
Protocol Synopsis 
Company:   
Aziyo Biologics, Inc.  
Protocol Number:  
CLP-0001 
Product: 
ViBone® Viable Bone Matrix 
Protocol Title: 
A Prospective, Post-Market, Multi-Center Study Evaluating 
ViBone in Cervical and Lumbar Spine Fusion 
Treatment Indication: 
Spondylosis, spondylolisthesis, degenerative disc disease, 
or herniated nucleus pulposus affecting either 1 to 3 
contiguous levels between C2 and C7 (for cervical 
patients) or L1 and S1 (for lumbar patients). 
Purpose: 
The purpose of this study is to assess clinical and 
radiographic outcomes in patients who undergo 1-3 level 
anterior cervical discectomy fusion (ACDF) or lumbar 
interbody fusion (TLIF, PLIF, ALIF, LLIF) using ViBone. 
Subjects will be followed for 12 months following surgery 
to determine the number of study subjects that are solidly 
fused at or before 12 months postoperatively. 
The data for cervical and lumbar fusions will be analyzed 
separately and will be compared to published and/or 
retrospective data for autograft or other similar graft 
materials.  
Design: 
Up to 50 patients undergoing ACDF using ViBone will be 
enrolled.   
Up to 50 patients undergoing lumbar interbody fusion 
using ViBone will also be enrolled.  
Subjects will be followed via the enrolling center’s 
standard of care for the procedure.   
Data from patients meeting the study criteria will be 
gathered at baseline, 6 months, and 12 months post-
surgery.    

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 3 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
Patient Population: 
 
Included are both male and female patients, 18-80 years 
of age with spondylosis, spondylolisthesis, degenerative 
disc disease, or herniated nucleus pulposus affecting 1, 2, 
or 3 contiguous levels of the spine between C2 and C7 (for 
cervical patients) or L1 and S1 (for lumbar patients).   
Patients must be undergoing ACDF or lumbar interbody 
fusion using ViBone to be eligible for the study.  
Outcome Measures: 
Primary: 
• 
Incidence of successful fusion measured 
radiographically by 12 months post-surgery  
 
Secondary: 
• Incidence of successful fusion measured 
radiographically by 6 months post-surgery  
• Oswestry Disability Index (ODI)/Neck Disability 
Index (NDI) relative to baseline. 
• Visual Analog Scale (VAS) relative to baseline. 
• Incidence of subjects experiencing ViBone-related 
serious adverse reactions.   
Duration: 
Subjects will be evaluated via routine follow up visits 
through 12 months post-surgery. 
Centers:                               Up to 20 centers in the U.S. 
 
 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 4 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
 
Study contact for discussion of protocol-specific issues: 
 
Stephanie Richardson 
Aziyo Biologics, Inc. 
Phone: 678-492-4712 
Email: srichardson@aziyo.com  
 
 
 
SAFETY REPORTING CONTACT INFORMATION: 
REPORTING OF SAFETY INFORMATION TO SPONSOR 
Aziyo pharmacovigilance designee and contact information for adverse reaction reporting: 
Stephanie Richardson 
Aziyo Biologics, Inc. 
Phone: 678-492-4712 
Email: srichardson@aziyo.com  
 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 5 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
 Table of Contents 
1 ABBREVIATIONS .............................................................................................................. 7 
2 TRADEMARK STATEMENTS ............................................................................................ 8 
3 INTRODUCTION ................................................................................................................ 8 
3.1 
Spine Fusion .............................................................................................................. 8 
3.2 
Viable Bone Allografts ................................................................................................ 8 
3.3 
Description of ViBone ................................................................................................. 8 
4 STUDY PURPOSE AND OBJECTIVES ............................................................................. 9 
4.1 
Study Purpose ............................................................................................................ 9 
4.2 
Objectives ................................................................................................................... 9 
5 STUDY DESIGN ................................................................................................................ 9 
5.1 
Design Summary ........................................................................................................ 9 
5.2 
Patient Enrollment ...................................................................................................... 9 
6 PATIENT SELECTION ..................................................................................................... 10 
6.1 
Study Population ...................................................................................................... 10 
6.2 
Eligibility criteria ........................................................................................................ 10 
6.2.1 
Informed Consent Form ..................................................................................... 10 
6.2.2 
Inclusion Criteria ................................................................................................ 11 
6.2.3 
Exclusion Criteria ............................................................................................... 11 
7 STUDY PROCEDURES ................................................................................................... 12 
7.1 
Schedule of Assessments ........................................................................................ 12 
7.2 
Study Visits ............................................................................................................... 13 
7.2.1 
Pre-Surgery Screening Visit ............................................................................... 13 
7.2.2 
Surgical Procedure Visit ..................................................................................... 13 
7.2.3 
Follow-Up Visits ................................................................................................. 13 
7.2.4 
Subject Close-Out .............................................................................................. 14 
7.3 
Study Monitoring ....................................................................................................... 14 
7.4 
Protocol Deviations ................................................................................................... 14 
8 STUDY PRODUCT .......................................................................................................... 14 
8.1 
ViBone Formulation and Packaging ......................................................................... 14 
8.2 
Labeling and Storage ............................................................................................... 14 
8.3 
Study Treatments ..................................................................................................... 15 
8.3.1 
Treatment Regimen ........................................................................................... 15 
8.3.2 
Study Duration ................................................................................................... 15 
9 PREMATURE SUBJECT WITHDRAWAL ........................................................................ 15 
10 OUTCOME MEASURES .................................................................................................. 15 
11 SAFETY ........................................................................................................................... 16 
11.1 Reporting Serious Adverse Reactions ...................................................................... 16 
12 STATISTICAL CONSIDERATIONS ................................................................................. 16 
12.1 Sample Size ............................................................................................................. 17 
13 DOCUMENTATION .......................................................................................................... 17 
13.1 Source Documents ................................................................................................... 17 
13.2 Case Report Forms .................................................................................................. 17 
14 ETHICS AND RESPONSIBILITY ..................................................................................... 17 
15 PROTOCOL AMENDMENTS ........................................................................................... 18 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 6 of 34 
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Effective Date: 04/15/2019 
 
16 USE OF INFORMATON AND PUBLICATION ................................................................. 18 
16.1 Use of Information .................................................................................................... 18 
16.2 Publication ................................................................................................................ 19 
17 STUDY TERMINATION ................................................................................................... 19 
18 CITED REFERENCES ..................................................................................................... 19 
19 APPENDICES .................................................................................................................. 20 
19.1 Appendix 1: Principal Investigator Agreement .......................................................... 20 
19.2 Appendix 2: Supplemental SAMPLE Informed Consent Form for ViBone Study ...... 21 
19.3 Appendix 4: ViBone Package Insert ......................................................................... 28 
19.4 Appendix 5: Oswestry Disability Index ...................................................................... 29 
19.5 Appendix 6: Neck Disability Index ............................................................................ 32 
19.6 Appendix 7: Visual Analog Scale .............................................................................. 34 
 
 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 7 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
1 
ABBREVIATIONS 
AATB 
American Association of Tissue Banks 
ACDF 
Anterior Cervical Discectomy and Fusion 
ALIF 
Anterior Lumbar Interbody Fusion 
Aziyo 
Aziyo Biologics, Incorporated 
BMI 
Body Mass Index 
BMP 
Bone Morphogenetic Protein 
C 
Celsius 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
cm 
Centimeter 
CMS 
Centers for Medicare and Medicaid Services 
CRF 
Case Report Form 
CT 
Computed Tomography 
CV 
Curriculum Vitae 
DBM 
Demineralized Bone Matrix 
DDD 
Degenerative Disc Disease 
DMARD Disease-Modifying Antirheumatic Drugs 
DMSO 
Dimethyl Sulfoxide 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EoT 
End of Treatment 
FDA 
Food and Drug Administration 
FFDCA 
Federal Food, Drug, and Cosmetic Act 
GCP 
Good Clinical Practice 
HCT/P 
Human Cellular and Tissue Based Product 
HIPAA 
Health Insurance Portability & Accountability Act 
HIV 
Human Immunodeficiency Virus 
ICBG 
Iliac Crest Bone Graft 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board (includes ethics committee) 
LLIF 
Lateral Lumber Interbody Fusion 
NaCl 
Sodium Chloride 
NDI 
Neck Disability Index 
ODI 
Oswestry Disability Index 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PLIF 
Posterior Lateral Interbody Fusion 
SOP 
Standard Operating Procedure 
TLIF 
Transforaminal Lateral Interbody Fusion 
VAS 
Visual Analog Scale 
WBC 
White Blood Count 
 
 
 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 8 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
2 
TRADEMARK STATEMENTS 
Aziyo® and ViBone® are registered trademarks of Aziyo, Inc.   
3 
INTRODUCTION 
3.1 
Spine Fusion 
Degenerative disorders of the spine can lead to a multitude of clinical problems including pain, 
weakness, numbness, tingling and deformity. When conservative (non-surgical) treatment fails 
after at least a 6-month period and/or non-operative treatment is not indicated, patients and 
physicians may turn to a surgical solution. Surgical options consist of decompressing nerves, 
correcting and/or stabilizing deformities if required and fusing the segment, depending on the 
clinical situation. The "gold standard" for aiding healing in spinal fusion surgeries is the 
harvesting of autograft from the patient's iliac crest and placing it in and around the segments of 
the spine that are intended to be fused. Autograft is considered the "gold standard" because it 
contains the essential elements required for successful bone grafting: osteogenesis, 
osteoconduction, and osteoinduction. 
However, the morbidity of harvesting autograft has been well documented and includes chronic 
donor-site pain, infection, neurologic injury, blood loss, deformity, bowel injury, hernia, and 
prolonged surgical and hospitalization time. There are now a number of products on the market 
to minimize or replace the use of autograft. However, few of these products contain all three 
essential bone-forming elements (osteogenesis, osteoconduction, and osteoinduction). 
3.2 
Viable Bone Allografts 
ViBone is a human tissue allograft consisting of cryopreserved bone matrix that is aseptically 
processed to preserve native factors that support bone repair. ViBone is a Human Cellular and 
Tissue Based Product (HCT/P) per 21 CFR Part 1271. It is restricted to homologous use for 
transplant in procedures on a single occasion by a licensed physician or surgeon.  
3.3 
Description of ViBone 
ViBone provides all three components critical for bone regeneration: osteoconductivity, 
osteoinductivity, and osteogenicity. It is a next generation cellular bone matrix that has been 
optimized to preserve the health of native bone cells and yield more readily available bioactive 
agents to enhance new bone formation while ensuring a safe allograft tissue for transplantation. 
 
ViBone is supplied ready to use and must be stored in its original packaging at -75°C to -85°C 
until prepared for use. It is the responsibility of the transplant facility or clinician to maintain the 
allograft intended for transplantation in the appropriate recommended storage conditions prior to 
transplant. Refer to the package insert (Appendix 4) for warnings and precautions and usage 
instructions. 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 9 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
4 
STUDY PURPOSE AND OBJECTIVES 
4.1 
Study Purpose 
The purpose of this prospective registry is to assess clinical and radiographic outcomes in 
patients who undergo ACDF or lumbar interbody fusion surgery using ViBone.   
4.2 
Objectives 
Subjects will be followed for 12 months post-surgery to determine the incidence of successful 
fusion at 12 months postoperatively. This data will be compared to published and/or 
retrospective data for autograft or other similar products.  
Additional study objectives include: 
• 
Incidence of successful fusion measured radiographically at 6 months post-surgery  
• 
Change from baseline in Oswestry Disability Index (lumbar interbody fusion patients) or 
Neck Disability Index (ACDF patients) 
• 
Change from baseline in Visual Analog Scale for back and leg pain 
• 
Incidence of ViBone-related serious adverse reactions 
5 
STUDY DESIGN 
5.1 
Design Summary 
This study is a multi-center, post-market, prospective patient registry to evaluate the clinical and 
radiographic outcomes of ViBone in patients undergoing cervical or lumbar spine fusion. Data 
will be gathered for up to 50 subjects undergoing ACDF surgery and up to 50 subjects 
undergoing lumbar interbody fusion surgery using ViBone. Total enrollment is expected to be 
approximately 200 subjects. The purpose of this study is to assess clinical and radiographic 
outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using 
ViBone. Subjects will be followed for 12 months post-surgery to determine the number of study 
subjects that are solidly fused at 12 months postoperatively. This data will be compared to 
published and/or retrospective data for autograft or other similar products.  
5.2 
Patient Enrollment 
All patients who sign an Institutional Review Board (IRB) approved Informed Consent Form (ICF) 
and an authorization for Protocol CLP-0001 for use of Protected Health Information (PHI) will be 
assigned a unique screening number consisting of a 4-digit sequential number assigned by 
Medrio EDC. 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 10 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
6 
PATIENT SELECTION 
6.1 
Study Population 
Up to 50 ACDF and up to 50 lumbar interbody fusion patients from up to twenty centers in the 
United States will be enrolled. The study population will consist of male and female patients, 18-
80 years of age. Eligible patients should have spondylosis, spondylolisthesis, degenerative disc 
disease, or herniated nucleus pulposus. Cervical fusion patients shall undergo ACDF surgery 
using ViBone at 1 to 3 contiguous levels between C2 and C7. Lumbar fusion patients shall 
undergo lumbar interbody fusion surgery using ViBone at 1 to 3 contiguous levels between L1 
and S1.   
6.2 
Eligibility criteria 
6.2.1 Informed Consent Form 
Each patient will be required to sign an IRB-approved ICF prior to enrollment in the study. 
The ICF and product package insert will be used to explain the study and fully disclose known 
risks and benefits. Subjects will not directly benefit from being in this study; however, the 
results of this study may help people undergoing spine fusion in the future. As with 
implantation of all human allograft tissue, risks associated with the implantation of ViBone 
include lack of response from the recipient (e.g., lack of fusion or non-union with adjacent 
tissue). It is also possible for a host site to become infected or the allograft tissue may cause 
an inflammatory response. Current technologies may not preclude the transmission of 
infectious agents or disease, including hepatitis and HIV. ViBone is preserved in 5% dimethyl 
sulfoxide (DMSO) in a 0.9% sodium chloride solution. Povidone iodine, Dulbecco’s phosphate 
buffered saline, sodium chloride irrigation solution, sodium phosphate, hydrochloric acid and 
hydrogen peroxide are all used for processing, preservation and storage of the allografts and 
trace amounts of these solutions may be present in the product. 
There are no additional medical risks involved in participating in this study. The only additional 
risk from taking part in this study is that the confidentiality of subject information may be lost or 
compromised. 
The ICF must include the elements required by the FDA in US 21 CFR 50 and International 
Conference on Harmonization (ICH) guidelines. 
Patients will also be required to consent to the use of their PHI according to all applicable 
health information privacy regulations. This authorization can be part of the ICF or can be a 
separate document. 
Each Investigator participating in the study is responsible for obtaining approval from Aziyo for 
any consent documents prior to their submission to their IRB and prior to their use. Each 
Investigator participating in the study is also responsible for ensuring that a written ICF and 
written authorization for use of PHI are obtained from each patient that they enroll into the 
study at the time of that patient’s enrollment. Documentation of the informed consent process 
must be completed by research personnel and the patient will receive a copy of the signed 
ICF. No study-related activities may be performed on any patient and no data may be 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 11 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
collected from any subject for study purposes prior to receiving these consents and 
authorizations.  
Subjects will be allowed to withdraw consent at any time for any reason. 
6.2.2 Inclusion Criteria 
In order to be eligible, patients are required to meet the following inclusion criteria: 
• Male or female, 18-80 years of age 
• For cervical cases – ACDF surgery at 1, 2, or 3 contiguous levels between C2-
C7 
• For lumbar cases – lumbar interbody fusion surgery at 1, 2, or 3 contiguous 
levels between L1-S1 
• Patient signed Informed Consent Form with HIPAA Authorization 
• Appropriate candidate for surgery 
• Patient will adhere to the scheduled follow-up visits and requirements of the 
protocol 
o Routine patient exams include pre-operative, operative, and at least two 
post-operative visits (6 and 12 months post-surgery) 
o Pre-operative and post-operative visits include radiological examination (X-
ray (required) and CT scan (if available)) 
6.2.3 Exclusion Criteria 
Patients are excluded if any of the following exclusion criteria are met prior to undergoing 
surgery: 
• 
Long term use of medications that are known to inhibit fusion or bone metabolism or 
immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, 
DMARDs, etc.) 
• 
Treatment with radiotherapy Both cervical and lumbar fusion during the same 
procedure 
• 
Acute or chronic systemic or localized spinal infections 
• 
Instability associated with major reconstructive surgery for primary tumors or metastatic 
malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, LLIF, 
and ALIF patients) spine  
• 
Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for 
TLIF, PLIF, LLIF, and ALIF patients) spine  
• 
Nursing mothers or women who are pregnant or plan to become pregnant during the 
course of the study 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 12 of 34 
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Effective Date: 04/15/2019 
 
• 
Current or recent history of malignancy or infectious disease. Patients with current or 
recent history of basal cell carcinoma are eligible.   
• 
Inability to provide informed consent 
• 
Rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis 
(bone density test score of ≤-2.5). 
• 
Other medical or surgical conditions which would preclude the potential benefit of 
surgery, such as congenital abnormalities, immunosuppressive disease, elevation of 
sedimentation rate unexplained by other diseases, elevation of white blood count 
(WBC), or marked left shift in the WBC differential count. 
• 
Active local or systemic infection or is undergoing adjunctive treatment for local or 
systemic infection. 
7 
STUDY PROCEDURES 
7.1 
Schedule of Assessments 
Study assessments are summarized below in Table 1, and are further described in Section 7.2. 
Table 1:  Schedule of Assessments  
 
Pre-Surgery 
Screening Visit 
Surgical 
Procedure Visit 
Follow-Up  
Visits 
(+/- 1 Month) 
Visit Window 
Day -30 to 0 
Day 0 
6 and 12 Months 
Post Surgery 
Inclusion/Exclusion 
Determination 
X 
 
 
Informed Consent/PHI 
Authorization 
X 
 
 
Baseline Demographics and 
Basic Patient Information 
X 
 
 
Surgical Procedure Details 
 
X 
 
Radiological Assessment 
(including flexion/extension)  
X1, 2 
 
X3 
Oswestry Disability Index 
(Lumbar Fusion) or Neck 
Disability Index (Cervical Fusion) 
X 
 
X 
Visual Analog Scale  
(Both Leg and Back Pain) 
X 
 
X 
ViBone-Related Serious 
Adverse Reactions Assessment 
 
 
As needed 
1 Baseline radiographs may be up to 12 months prior to the surgical procedure. 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 13 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
2 Flexion/extension x-rays are not required at baseline, but will be collected if captured. 
3 Flexion/extension x-rays are required at all follow-up visits. 
7.2 
Study Visits 
All procedures and evaluations must be performed at the study site. No study procedures can be 
conducted until the subject has provided written informed consent. 
7.2.1 Pre-Surgery Screening Visit   
The Pre-Surgery Screening Visit may take place up to and including 30 days prior to the date 
of the surgical procedure. The following information shall be collected during the Pre-Surgery 
Screening Visit: 
• 
Inclusion/Exclusion Determination 
• 
Written informed consent and written authorization for use and disclosure of PHI  
• 
Demographics (age, gender, ethnicity/race) 
• 
Medical History  
• 
Physical Exam, including height, and body weight  
• 
Oswestry Disability Index (lumbar fusion) (Appendix 5) or Neck Disability Index (cervical 
fusion) (Appendix 6) 
• 
Visual Analog Scale (both leg and back pain) (Appendix 7) 
• 
Radiological Assessment – at minimum, lateral and anterior/posterior radiographs are 
required at baseline.  Flexion and extension radiographs will also be collected if captured 
by the investigator.  If performed, CT scans will also be collected.   
7.2.2 Surgical Procedure Visit  
The Surgical Procedure Visit shall occur on the same day as the surgical procedure. The 
following information shall be collected during the Surgical Procedure Visit: 
• 
Surgical procedure details including the type of fusion performed, spine levels involved, 
ViBone, and other products used. 
• 
If another product is being used in the interbody space, at least 70% of the total volume 
should be ViBone. 
7.2.3 Follow-Up Visits 
Study-related Follow-Up Visits shall occur at 6 months and 12 months (± 1 month) after the 
date of the surgical procedure. The following information shall be collected at each Follow-Up 
Visit: 
• 
Surgical Complication Assessment 
• 
Oswestry Disability Index (lumbar fusion) or Neck Disability Index (cervical fusion) 
• 
Visual Analog Scale (both leg and back pain) 
• 
Radiological Assessment – at minimum, lateral, anterior/posterior, flexion and extension 
radiographs are required at each follow-up visit.  If performed, CT scans will also be 
collected. 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 14 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
 
7.2.4 Subject Close-Out  
The Subject Close-Out shall be performed for all patients enrolled, as well as if either: 
(1)  A subject is assigned a subject ID in the EDC, but does not undergo treatment;   
(2)  A subject terminates early from the study for any reason.  
 
7.3 
Study Monitoring 
Individual study sites may be monitored periodically to assure satisfactory enrollment, data 
recording, and adherence to the protocol. The frequency of monitoring of a study site may vary 
depending on its enrollment rate and the quality of data collected. The Investigator and staff are 
expected to cooperate with the monitor at each site visit and provide all relevant study 
documentation upon request for review. In addition to regular visits, each site may be monitored 
by phone and/or fax to keep abreast of subject status and to answer questions. 
7.4 
Protocol Deviations 
This study will be conducted as described in this protocol, except for an emergency situation in 
which the protection, safety, and well-being of the subject requires immediate intervention, based 
on the judgment of the Investigator (or a responsible, appropriately trained professional 
designated by the Investigator). In the event of a significant unforeseen deviation from the 
protocol (e.g., deviation impacting subject safety, obtaining informed consent prior to conducting 
study procedures, control of study product), the Investigator or his or her designee must contact 
Aziyo immediately by telephone. When at all possible, the deviation should also be 
reviewed/approved by the IRB in accordance with IRB policies.   
8 
STUDY PRODUCT 
8.1 
ViBone Formulation and Packaging 
The Package Insert contains a full discussion of ViBone formulation and packaging. (Appendix 
4). 
8.2 
Labeling and Storage 
The product label contains the elements required by the code of federal regulations (CFR), the 
American Association of Tissue Banks (AATB) and other local authorities for tissue products. 
ViBone is supplied ready to use and must be stored in its original packaging at -75°C to -85°C 
until prepared for use. It is the responsibility of the transplant facility or clinician to maintain the 
allograft intended for transplantation in the appropriate recommended storage conditions prior to 
transplant. 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
Page 15 of 34 
Revision 4 
 
Effective Date: 04/15/2019 
 
8.3 
Study Treatments 
8.3.1 Treatment Regimen 
ViBone will be implanted at the time of surgery.  
8.3.2 Study Duration 
Subjects enrolled in the registry will be followed for 12 months.  
9 
PREMATURE SUBJECT WITHDRAWAL 
Participation is voluntary and all subjects have the right to withdraw their participation from the 
study at any time. Subjects will be withdrawn from the study immediately if any of the following 
occurs: 
• 
the Investigator determines it is in the best interest of the subject, or 
• 
the subject withdraws informed consent, or 
• 
the subject withdraws authorization to use protected health information. 
Aziyo or its designee must be notified promptly when a subject is withdrawn. The Investigator will 
encourage all subjects who decide to withdraw from the study to complete all evaluations that may 
be necessary to ensure that the subject is free of untoward effects and to seek appropriate follow-
up for any continuing problems. The date the subject is withdrawn from the study and the reason 
for discontinuation will be recorded in the electronic data capture system. When a subject is 
withdrawn from the study, regardless of the reason, all evaluations required at the final study visit 
should be performed.  
10 OUTCOME MEASURES 
The following outcome measures will be assessed at 6 months and 12 months and compared to 
published and/or retrospective data for autograft or other similar products:  
Study objectives are to detect: 
• 
Fusion rates as determined by radiographic imaging at 6 and 12 months post-surgery. 
o Fusion of the interbody space shall be deemed successful if the following radiographic 
endpoints are demonstrated on x-ray examination (lateral, anterior/posterior, flexion 
and extension): Evidence of bridging trabecular bone between the involved motion 
segments, translational motion <3mm; and angular motion <5º.1     
• 
Changes in Oswestry Disability Index/Neck Disability Index from baseline, at all available 
follow-up time-points. 
• 
Changes in Visual Analog Scale (VAS) from baseline, at all available follow-up time-points. 
Safety evaluations include: 
• 
Incidence of ViBone-related serious adverse reactions.   

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
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11 SAFETY  
11.1 Reporting Serious Adverse Reactions 
Adverse Reactions involving a communicable disease and are deemed related to use of ViBone, 
will be reported to FDA’s MedWatch program and details of the event shall be documented on the 
applicable Serious Adverse Reaction form.2  Per FDA 21 CFR 1271.3 (y), an adverse reaction is 
defined as a noxious and unintended response to any HCT/P for which there is a reasonable 
possibility that the HCT/P caused the response. 
Per FDA 21 CFR 1271.350 adverse reactions involving a communicable disease related to an 
HCT/P (ViBone) must be investigated and reported to the FDA within 15 calendar days of initial 
receipt of the information.  Adverse reactions are further defined to include the following: 
A communicable disease that: 
1. Is fatal (report if you suspect the death was an outcome of the adverse event); 
2. Is life threatening (subject at substantial risk of dying at the time of the adverse event, or use 
or continued use of the device or other medical product might have resulted in the death of the 
subject; 
3. Results in permanent impairment of body function or permanent damage to body 
structure (Report if the adverse event resulted in a substantial disruption of a person's ability 
to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or 
permanent change, impairment, damage or disruption in the subject's body function/structure, 
physical activities and/or quality of life); or 
4. Necessitates medical or surgical intervention, including hospitalization (report if 
hospitalization is the result of an adverse event. Emergency department visits that do not 
result in admission should be evaluated for one of the other outcomes). 
If an adverse reaction involving a communicable disease that is believed to be related to the use 
of ViBone occurs, a Serious Adverse Reaction form shall be completed. In addition to 
completing the form, Aziyo must be notified within 24 hours of the Investigator becoming aware 
of the event. All fields are required in order to provide Aziyo personnel with the required 
information to evaluate the reaction and complete the required MedWatch report for submission 
to FDA per the Sponsor’s Medical Device Reporting SOP.   
12 STATISTICAL CONSIDERATIONS 
As this study is designed to assess the clinical and radiographic outcomes in patients who undergo 
cervical (ACDF) or lumbar (TLIF, PLIF, LLIF, or ALIF) spine fusion surgery using ViBone, statistics 
will be descriptive. Baseline demographic and clinical variables will be summarized. Frequencies 
and percentages with confidence intervals will be tabulated for surgical outcomes. 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
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12.1 Sample Size 
Up to 50 patients undergoing ACDF surgery using ViBone will be enrolled. Up to 50 patients 
undergoing lumbar interbody fusion surgery using ViBone will also be enrolled. 
13 DOCUMENTATION  
13.1 Source Documents 
Source documents are defined as original documents, data, and records. They may include 
hospital records, clinical and office charts, laboratory data and information, subject diaries or 
evaluation checklists, pharmacy dispensing and other records, recorded data from automated 
instruments, microfiches, photographic negatives, microfilm, magnetic media and X-rays, or 
other information closest to its source. All Investigators and institutions will permit trial-related 
monitoring, audit, IRB and regulatory inspections, and will provide direct access to source 
documents. 
13.2 Case Report Forms 
Aziyo will provide access to electronic CRFs for the recording and collection of data via Medrio 
electronic data capture (EDC). These forms will be used to transmit information collected during 
this study to Aziyo. The Investigator must agree to complete and maintain source documents and 
complete CRFs for each subject participating in the study. All information entered into electronic 
CRFs must also be reflected in the subject source documents. 
The Investigator or designated sub-Investigator will review the CRFs for completeness and 
accuracy and approve where indicated. CRFs will be reviewed periodically for completeness, 
legibility, and acceptability by Aziyo. Aziyo will be allowed access to all source documents 
pertinent to the study in order to verify CRF entries as needed. 
14 ETHICS AND RESPONSIBILITY 
This study must be carried out in compliance with the protocol and the ethical principles that have 
their origin in the Declaration of Helsinki; Title 21 of the Code of Federal Regulations §§ 50, 54, 
and 56, and ICH E6. 
The Investigator agrees, when signing the protocol, to adhere to the instructions and procedures 
described in it.   
The Investigator will supply the following to the study site’s IRB: 
• 
Protocol and any amendment(s) 
• 
Informed consent and written authorization for use and disclosure of PHI document and 
updates 
• 
Package Insert and product brochure 
• 
Relevant curriculum vitae, if required 
• 
Adverse reaction reports, as appropriate 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
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The following documents must be provided to Aziyo, or its designee, prior to the start of the study: 
• 
Current curriculum vitae (no more than two years old) and current state medical license of 
Principal Investigator and all sub-Investigators  
• 
Protocol and amendment(s) signature pages 
• 
Copy of the IRB approval letter for the protocol and informed consent and written 
authorization for use and disclosure of PHI document, signed by the IRB chairperson or their 
designee, including the name and address of the IRB 
• 
IRB approvals of any amendments to the protocol or revisions to the informed consent and 
written authorization of use and disclosure of PHI document, including the IRB stamp and 
date 
• 
Debarment Statement confirming that no one involved in the study is debarred 
• 
Proof of Patient written authorization for use and disclosure of PHI, as applicable 
• 
Stamped and dated copy of the IRB approved informed consent and written authorization for 
use and disclosure of PHI form and any revisions. 
The following documents must be provided to Aziyo, or its designee, as applicable: 
• 
IRB re-approval of the protocol, at least annually 
• 
Relevant revisions to curriculum vitae signed and dated, as applicable 
15 PROTOCOL AMENDMENTS 
Protocol amendments will only be made by Aziyo. The IRB must review and provide approval for 
any amendments likely to affect the safety of the subjects or the conduct of the study. The 
Investigator should send a copy of the approval letter from the IRB or Independent Ethics 
Committee (IEC) to Aziyo or its designee. 
16 USE OF INFORMATON AND PUBLICATION 
16.1 Use of Information 
All information concerning ViBone and Aziyo Biologics, Inc. patent applications, formulas, 
manufacturing processes, basic scientific data, or formulation information, supplied by Aziyo and 
not previously published is considered confidential information. 
The information developed during the conduct of this study is also considered confidential and 
will be used by Aziyo in connection with the development of ViBone. This information may be 
disclosed as deemed necessary by Aziyo to other Investigators, other pharmaceutical 
companies, and governmental agencies. To allow for the use of the information derived from this 
study and to ensure complete and thorough analysis, the Investigator is obligated to provide 
Aziyo with complete test results and all data developed in this study and to provide direct access 
to source data and documents for study-related monitoring, audits, IRB review, and regulatory 
inspection. 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
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This confidential information shall remain the sole property of Aziyo, shall not be disclosed to 
others without the written consent of Aziyo, and shall not be used except in the performance of 
this study. 
The Investigator will maintain a confidential subject identification code list of all subjects enrolled 
in the study by name and subject number. This list will be maintained at the study site and will 
not be retrieved by Aziyo. The Investigator must obtain patient written authorization for the use 
and disclosure of PHI according to the Health Insurance Portability Act of 1996 or other local 
privacy laws. 
16.2 Publication 
At the completion of the study, publications may be authored by specified Investigators who 
contribute significantly to the implementation and conduct of the study, and by non-site personnel 
who contribute substantially to the design, interpretation, or analysis of the study. 
 
The outcome data for cervical and lumbar fusions will be analyzed separately and will be 
compared to published and/or retrospective data for autograft or other similar products. 
17 STUDY TERMINATION 
Aziyo may terminate this study prematurely, either in its entirety or a specific study site, for 
reasonable cause provided that written notice is submitted a reasonable time in advance of the 
intended termination. The Investigator may also terminate the study at his or her site for 
reasonable cause, after providing written notice to Aziyo a reasonable time in advance of the 
intended termination. Advance notice is not required by either party if the study is stopped due to 
safety concerns. If Aziyo terminates the study for safety reasons, it will immediately notify the 
Investigator by telephone and subsequently provide written instructions for study termination. 
18 CITED REFERENCES 
1. FDA. Guidance for Industry and/or FDA Reviewers/Staff. Guidance Document for the 
Preparation of IDEs for Spinal Systems. 2000. 
2. FDA. MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to 
Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). 2005. 
3. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine 2000 Nov 15;25(22):2940-52. 
4.  Vernon, H. & Mior, S. (1991). The Neck Disability Index: A study of reliability and validity. 
Journal of Manipulative and Physiological Therapeutics. 14, 409-415 
 
 

 
DOCUMENT TITLE:   
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in Cervical and Lumbar Spine Fusion 
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19 APPENDICES 
19.1 Appendix 1: Principal Investigator Agreement 
Principal Investigator Agreement 
  
I have read and understood the contents of this protocol and the information provided as it relates to 
the study product and agree to conduct this treatment protocol in compliance with the protocol, Good 
Clinical Practice, and other applicable regulatory requirements.  
 
I accept the oversight of the treatment protocol monitor designated by Aziyo, and control procedures, 
including verification by access to source documents, as required by the protocol monitoring and audit 
functions of Aziyo or its designee and the audit functions of regulatory agencies in accordance with 
Good Clinical Practice.  
 
Per ICH and GCP I will ensure the accuracy, completeness, and timeliness of the data reported to the 
sponsor in the eCRFs. 
 
I understand that any changes to this protocol (not associated with procedures necessary for the safety 
of the patient) instituted by me or those I directly designate will constitute a violation of the protocol 
unless specifically discussed with the Aziyo Biologics, Inc. monitor or designee beforehand.  
 
I agree that neither I nor any person employed by me in connection with any work to be performed for 
or on behalf of Aziyo has been debarred under Section 306(a) or (b) of the Federal Food, Drug and 
Cosmetic Act, and that no debarred person will in the future be employed by me in connection with any 
work to be performed for or on behalf of Aziyo. If at any time after execution of this Agreement, I 
become aware that I or any person employed by me in connection with any work to be performed for or 
on behalf of Aziyo shall become or shall be in the process of being debarred, I agree to notify Aziyo at 
once. 
 
I will personally conduct the treatment and follow-up as described herein, or will oversee and remain 
fully responsible for the treatment and follow-up as described herein if I delegate any parts of it.  
 
 
 
 
Principal Investigator:  
 
 
 
Print 
 
Signature 
 
 
 
 
Date: 
 
 
 
 
 
 
 
 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
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19.2 Appendix 2: Supplemental SAMPLE Informed Consent Form for ViBone Study 
Supplemental SAMPLE Informed Consent Form for ViBone Study 
 
Title: 
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion  
 
Protocol Number: 
CLP-0001 
 
WIRB® Protocol #XXXXX 
 
Sponsor: 
Aziyo Biologics, Inc. 
 
Investigator: 
Name 
 
Address 
 
City, State Zip 
 
Country 
 
Study Related 
Phone Number(s): 
Name 
 
Phone number (24 hours) 
 
Summary 
You are being asked to be in a research study evaluating ViBone, a donated human tissue 
product, in patients undergoing cervical or lumbar spine fusion. The purpose of this consent form 
is to help you better understand the study purpose and requirements and to help you determine 
if you’d like to participate. 
ViBone is processed from donated human bone. The bone is processed in a way that 
preserves the native growth factors and cells needed for bone formation.   
You should not join this research study until all of your questions are answered. 
Things to know before deciding to take part in a research study: 
• The main goal of a research study is to learn more about spine fusion in order to help 
patients in the future. 
• The main goal of regular medical care is to help each patient. 
• The decision to join or not join the research study will not cause you to lose any medical 
benefits. If you decide not to take part in this study, your doctor will continue to treat you. 
• This study involves standard medical care. Standard care is the treatment normally 
given for a certain condition or illness. 
• Your medical records will become part of the research record. Before sharing your 
records with the sponsor of the study, your doctor will remove any personal information 
(name, date of birth, etc.) that would allow you to be identified. These deidentified 
medical records may be looked at and/or copied by the sponsor of this study and 
government agencies or other groups associated with the study. 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
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• Your medical insurance may be billed for any standard medical care you receive during 
the research study. If your insurance company is billed then it may have access to the 
research records. Insurance companies may not pay for treatment that is part of a 
research study. Taking part in a research study could affect your current or future 
insurance coverage. 
If you take part in this research study, you will be given a copy of this consent form. This 
consent form is a supplemental consent specifically for the study evaluating ViBone in cervical 
and lumbar spine fusion. You will also need to sign other consent form(s) for your surgical 
procedure. 
What is the purpose of the study? 
During your spine fusion procedure, your doctor will use ViBone, a human tissue allograft that 
is intended to support bone repair. ViBone is used in fusion surgery to stop motion between 
two or more vertebral bodies. ViBone and other bone allografts may stimulate new bone 
formation and may provide a foundation or scaffold on which your body can grow new bone.   
ViBone is a human tissue allograft consisting of viable bone matrix that is processed in a way 
that preserves native factors that support bone repair. ViBone is regulated by the Food and Drug 
Administration as a Human Cellular and Tissue Based Product (HCT/P) per 21 CFR Part 1271.   
The purpose of this study is to gather additional information on the use of ViBone when it is used 
in patients undergoing cervical or lumbar spine fusion. 
How long will the study last and how many people will be in the study?   
Your involvement in this study will last for approximately twelve months. You will have at least 
two routine follow-up evaluations, one at 6 months and another at 12 months after your 
surgical procedure. Up to 20 U.S. clinical sites will be participating in the study and 
approximately 200 patients are expected to be enrolled.  
What are the procedures required by the study and are there any extra tests or 
treatments required if I participate? 
Your procedure will be performed per the standard of care by your physician. Although 
participation in the study requires no additional procedures or tests, it is important that you 
comply with standard of care by attending the scheduled follow-up visits as recommended by 
your physician. Your physician will provide the following information from your visits and your 
medical records: 
• Demographic information (age, race, gender) 
• Date and type of procedure performed 
• Information on any hardware used in the procedure 
• Information on ViBone implanted 
• ViBone-related serious adverse reactions 
• Imaging related to your procedure and details on your fusion 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
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Are there any additional risks or discomforts associated with participation?  
There are no identified medical risks involved in participating in this study. The only additional 
risk from taking part in this study is that the confidentiality of your information may be lost or 
compromised. 
Please discuss the standard risks associated with your procedure and the use of allograft tissue 
products with your physician. 
Will I benefit from participation in this study? 
You will not directly benefit from being in this study. However, the results of this study may 
help people undergoing spine fusion in the future. 
Who will pay for the surgery, associated products and follow-up care required for the 
fusion procedure? 
You or your insurance company will be billed for your surgery, medications, visits and any 
other standard treatment/care. 
You may want to talk with your insurance company about its payment policy for standard 
medical care given during a research study. If your insurance company does not pay, you may 
be billed for those charges. 
Will I be compensated for participation in this study? 
There is no payment provided to patients for participation in this study. 
Are there alternatives to participating in this study? 
You do not need to take part in this research study to receive treatment for your condition. You 
can undergo the same surgery with the same product without taking part in this study. Your 
study doctor can discuss treatment alternatives and the risks and benefits of these alternatives 
with you. If you decide to not participate in this study, it will not affect your medical treatment in 
any way. 
AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH PURPOSES 
What information may be used and given to others? 
The study doctor will get your personal and medical information. For example: 
• Past and present medical records 
• Research records 
• Records about phone calls made as part of this research 
• Records about your study visits 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
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Who will see my medical information? 
Your privacy is very important to us and the researchers will make every effort to protect it. Your 
information may be given out if required by law. Some of your health information from this study 
will be kept in a central database for research. Your name or contact information will not be put in 
the database. 
There are organizations that may inspect your records. These organizations are required to make 
sure your information is kept private, unless required by law to provide information. Some of 
these organizations are: 
• The study sponsor Aziyo Biologics, Inc. 
• The Institutional Review Board (IRB) is a group of people who review the research with 
the goal of protecting the people who take part in the study. 
• The Food and Drug Administration  
Absolute confidentiality cannot be guaranteed because of the need to give information to these 
parties. The results of this research study may be presented at meetings or in publications. Your 
identity will not be disclosed in those presentations. 
Who may use and give out information? 
The study doctor and the study staff. 
Why will this information be used and/or given to others? 
• to do the research, 
• to study the results, and 
• to see if the research was done right. 
If the results of this study are made public, information that identifies you will not be used. 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
How will information about me be kept private?  
Your privacy is very important to the researchers. Here are a few of the steps they will take: 
1) When your sample(s) is sent to the researchers, no information identifying you (such 
as your name) will be sent. Samples will be identified by a unique code only. 
2) The list that links the unique code to your name will be kept separate from your 
sample and health information. 
3) Information that identifies you will not be given to anyone, unless required by law. 
4) If research results are published, your name and other personal information will not 
be used. 
May I review or copy my information? 

 
DOCUMENT TITLE:   
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Yes, but only after the research is over. 
May I withdraw or cancel my participation in this study? 
Yes. You can decide to discontinue at any time. If you decide to stop for any reason, it is 
important to let the study doctor know as soon as possible. If you stop, you can decide whether 
or not to let the study doctor continue to provide your medical information to the organization 
running the study. Information that has already been given to or used by researchers will not 
be returned. 
The study doctor may take you out of the study: 
• If your health changes and the study is no longer in your best interest 
• If new information becomes available 
• If the study is stopped by the sponsor, IRB or FDA. 
Is my health information protected after it has been given to others? 
There is a risk that your information will be given to others without your permission. 
Who pays for the study-related activities? 
The sponsor, Aziyo Biologics, Inc., will pay for the data collection efforts associated with this 
research study. 
Who can answer my questions about this study? 
Contact [name] at [number(s)] (24 hours) if you have any questions or concerns about this study. 
If you have questions about your rights as a research subject or if you have questions, concerns or 
complaints about the research, you may contact: 
 
Western Institutional Review Board® (WIRB®) 
 
1019 39th Avenue SE, Suite 120 
 
Puyallup, Washington  98374-2115 
 
Telephone:  1-800-562-4789 or 360-252-2500 
 
E-mail: Help@wirb.com 
 
An Institutional Review Board is a group of people who independently review research. 
The Institutional Review Board will not be able to answer some study-specific questions.  
However, you may contact the IRB if the research staff cannot be reached or if you wish to talk 
to someone other than the research staff. 
Do not sign this consent form unless you have had a chance to ask questions and have gotten 
satisfactory answers. 
If you agree to be in this study, you will receive a signed and dated copy of this consent form for 
your records. 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
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A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time. 
 
 
 
 
 
CONSENT 
I have read this consent form (or it has been read to me). All my questions about the study and 
my part in it have been answered. I freely consent to be in this research study. 
 
By signing this consent form, I have not given up any of my legal rights. 
 
 
 
__________________________________________ 
Subject Name (printed) 
 
 
________________________________________ 
__________________ 
Signature of Subject 
Date 
 
 
________________________________________ 
__________________ 
Printed Name of Person Conducting the 
Position 
Informed Consent Discussion 
 
 
________________________________________ 
__________________ 
Signature of Person Conducting the  
Date 
Informed Consent Discussion 
 
 
 

 
DOCUMENT TITLE:   
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DOCUMENT TITLE:   
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in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
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19.3 Appendix 4: ViBone Package Insert 
 

 
DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
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19.4 Appendix 5: Oswestry Disability Index 
 

 
DOCUMENT TITLE:   
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in Cervical and Lumbar Spine Fusion 
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CLP-0001 
 
 
 
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DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
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DOCUMENT TITLE:   
A Prospective, Post-Market, Multi-Center Study Evaluating ViBone 
in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
CLP-0001 
 
 
 
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19.5 Appendix 6: Neck Disability Index 
 
 
 
 

 
DOCUMENT TITLE:   
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in Cervical and Lumbar Spine Fusion 
DOCUMENT NUMBER:  
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DOCUMENT TITLE:   
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in Cervical and Lumbar Spine Fusion 
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19.6 Appendix 7: Visual Analog Scale