Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation
Phase: NA
Conditions: Lumbar Degenerative Disc Disease
Sponsor: Spineology, Inc

Assigned NCT Identifier
NCT02347410

Sponsor Summary 
 
Trial Sponsor: 
 
Primary Contact: 
 
 
Address: 
 
 
 
Spineology, Inc. 
 
 
 
 
7800 Third Street North 
Suite 600 
St. Paul, MN 55128-5455 
 
Phone: 
 
Fax: 
 
Email: 
 
 
 
 
 
Trial Product: 
Spineology Interbody Fusion System (SIFS) 
 
IDE Number: 
 
G140140 
 
 
 
 
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Table of Contents 
 
1.0 INTRODUCTION AND BACKGROUND 
………….…..…………….…………………….……… 
6 
 
1.1 
DEVICE DESCRIPTION 
……………………………………………………………………………………… 
7 
 
1.2 
INTENDED USE 
………………………………………………………….…………………….…………… 
8 
 
1.3 
INDICATIONS FOR USE 
……………………………………………...…………………………………….. 
8 
 
1.4 
INSTRUCTIONS FOR USE 
…………………………………………………………………………………… 
9 
 
1.5 
CONTRAINDICATIONS AND CAUTIONS 
…………….………………………………………………………… 
9 
 
 
 
2.0 PURPOSE AND INVESTIGATION OBJECTIVES 
………………….…………………………….. 
10 
 
2.1 
PURPOSE 
………………………………………………………………………………………………….. 
10 
 
2.2 
INVESTIGATION OBJECTIVES 
……………………………………………………….…………………….. 
10 
 
2.3 
STUDY DURATION 
…………………………………………………………………………………………. 
11 
 
 
 
3.0  INVESTIGATION DESIGN 
……………………………………………………………….………… 
12 
 
3.1 
OVERVIEW AND GENERAL DESIGN 
………………………………………………….……………………... 
12 
 
3.2 
SCIENTIFIC SOUNDNESS AND STATISTICAL ANALYSIS 
……………………………………………………. 
12 
 
 
3.2.1 
Primary Endpoint 
………………………………………………………………………………. 
12 
 
 
3.2.2 
Additional Outcomes 
……………………………….…….…………………………………… 
13 
 
 
3.2.3 
Statistical Methods 
…………………………………….………………………………………. 
13 
 
 
3.2.4 
Determination of Sample Size 
…....…………….……………………………………………. 
14 
 
 
3.2.5 
Sample Size Re-Estimation 
…………………………………………………………………. 
14 
 
 
3.2.6 
Analysis of Primary Endpoint 
…….……….……….…………………………………………. 
14 
 
 
3.2.7 
Analysis of Additional Outcomes 
….……..………….……………………………………… 
15 
 
 
3.2.8 
Data Management Plan 
……………………………………………………………………… 
17 
 
 
3.2.9 
Subject Withdrawal 
…………………………………………………………………………… 
17 
 
 
3.2.10 
Control Subject Population 
…...………………….…..……………………………………… 
18 
 
 
3.2.11 
Randomization 
…………………………………….…………………………………………… 
18 
 
 
3.2.12 
Minimization of Bias 
………………………………………………………………………….. 
18 
 
 
 
4.0 SELECTION OF SUBJECTS 
……………………………………………………………………….. 
19 
 
4.1 
INVESTIGATION POPULATION 
……………………………………………………………………………… 
19 
 
4.2 
INCLUSION CRITERIA 
……………………………………………………………………………………… 
19 
 
4.3 
EXCLUSION CRITERIA 
……………………………………………………………………………………. 
20 
 
 
 
5.0 TREATMENT 
………………………………………………………………..………………………… 
22 
 
5.1 
INVESTIGATIONAL PRODUCT  …………….……………………………...………………………………….. 
22 
 
5.2 
DESCRIPTION OF PROCEDURE 
…………..………………………………………………………………… 
22 
 
5.3 
ASSESSMENTS AND PATIENT CARE 
….……………………………….…………………………………… 
23 
 
 
5.3.1 
Screening and Enrollment 
……………………………..…………………………………… 
23 
 
 
5.3.2 
Study Interval Evaluations 
…………………………..……………………………………… 
23 
 
 
5.3.3 
Baseline/Pre-Procedure 
……………………………………………………………………… 
25 
 
 
5.3.4 
Surgery/Hospitalization 
…..………………………………..………………………………… 
25 
 
 
5.3.5 
6-Week Study Interval 
……………………………………………………………………… 
25 
 
 
5.3.6 
3-Month Study Interval 
………………………………………………………………………. 
25 
 
 
5.3.7 
6-Month Study Interval 
………………………………………………………………………. 
26 
 
 
5.3.8 
12-Month Study Interval 
…………………………..………………………………………… 
26 
 
 
5.3.9 
24-Month Study Interval – Final Examination 
…………..………………………………… 
26 
 
 
5.3.10 
36-Month Study Interval – Remote Assessment 
………………………………………….. 
26 
 
 
5.3.11 
48-Month Study Interval – Remote Assessment 
………………………………………….. 
27 
 
 
 
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6.0 RADIOGRAPHIC EVALUATIONS 
………………………………………………….………………. 
27 
 
 
 
7.0 BENEFIT / RISK ANALYSIS 
…………..…………………………………………………………….. 
29 
 
7.1 
BENEFITS 
…………………………..………………………………………………………………………. 
29 
 
7.2 
RISKS 
……………………………..………………………………………………………………………… 
29 
 
 
7.2.1 
SIFS MESH RISKS 
……………………………………………………………………………….. 
29 
 
 
7.2.2 
G2 DRY MIX GRAFT RISKS 
………………………………………………………………………. 
29 
 
 
7.2.3 
SURGERY RISKS 
…………………………………………………………………………………. 
29 
 
7.3 
RISK MINIMIZATION 
……………..…………………………………………………………………………. 
30 
 
 
 
8.0 SAFETY EVALUATION 
……………………………………………………………………………… 
31 
 
8.1 
EVENT ADJUDICATION PROCEDURE 
……………………………………………………………………….. 
31 
 
8.2 
SERIOUS ADVERSE EVENTS 
……………………………………………………………………………….. 
32 
 
8.3 
ADVERSE EVENT SEVERITY 
……………………………………………………………………………….. 
32 
 
 
 
9.0 ETHICS 
………………………………………………………………………………………………… 
34 
 
9.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
………………….…………………………………………………. 
34 
 
9.2 
INFORMED CONSENT 
……………………………………...………………………………………………. 
34 
 
9.3 
PATIENT DATA CONFIDENTIALITY 
………………………………………………………………………….. 
34 
 
9.4 
DATA MONITORING COMMITTEE (DMC) 
……………………..…………………………………………… 
36 
 
9.5 
FINANCIAL DISCLOSURE 
……………………………………………………………………………………. 
36 
 
9.6 
RADIOGRAPHIC CORE LAB 
………………………………………………………………………………… 
36 
 
9.7 
INVESTIGATIONAL DEVICE USE AND ACCOUNTABILITY 
…………………………………………………… 
37 
 
 
 
10.0 DATA COLLECTION FORMS 
………………………………..……………………………………. 
38 
 
11.0 DEFINITIONS 
………………………………………………….…………………………………….. 
41 
 
12.0 PROTOCOL DEVIATION 
…………………….…..………………………………………………… 
44 
 
13.0 COMPLIANCE 
……………………………………..………………………………………………… 
45 
 
14.0 INVESTIGATOR RESPONSIBILITY 
……………………………………………………………….. 
46 
 
15.0 SPONSOR RESPONSIBILITY 
……………………………………………………………………. 
47 
 
16.0 MONITORING PLAN 
……………………………………..…………………………………………. 
48 
 
17.0 REFERENCES 
…………………………………………….………………………………………… 
50 
 
18.0 STUDY SPONSOR 
……………….………………………..………………………………………. 
52 
 
19. REVISION HISTORY 
…….……………………………………..……………………………………. 
53 
 
 
 
 
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APPENDICES 
 
I 
Surgical Technique Manual   
 
II 
Waddell Test Description 
 
III 
Investigational Device Labeling    
 
IV 
Radiographic and Core Lab Assessments 
 
V 
Data Monitoring Committee (DMC) 
 
VI 
Sample Informed Consent Template 
 
VII 
Sample Case Report Forms 
 
 
 
 
 
 
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1.0 
INTRODUCTION AND BACKGROUND 
In the process of degenerative disc disease (DDD), the intervertebral disc is often found to 
be the primary source of pain.1- 7   Spinal fusion procedures that stop motion at the disc are 
currently the preferred treatment for DDD.  Posterior and posterolateral fusion procedures 
have been used, and fusion rates range from 46% to 100%.8 – 18  Fusion with internal spinal 
instrumentation has been shown to yield more reliable (80% to 90%) fusion rates.1, 19, 20 
 
Removal of the disc followed by an interbody fusion procedure is the most reliable 
procedure for treating a painful disc because it can restore tension to the annulus and 
further curtail motion.4, 21-26  A successful interbody fusion is more likely to result in a 
successful clinical outcome (pain reduction, function improvement).6  A bone graft placed in 
the intervertebral disc space has a potential mechanical advantage over posterior or 
posterolateral fusions by allowing restoration of disc space height, sagittal plane alignment, 
and weight bearing through the anterior column.19, 21-23, 27-29  The disc space provides a 
large surface area for fusion, and compressive loads applied to the graft stimulate 
osteogenesis and fusion. 
 
The clinical outcomes of anterior and posterior interbody fusions are similar.19,30  An 
anterior interbody fusion allows a surgeon to avoid dissection of posterior paraspinal 
muscles and manipulation of the spinal cord and nerves.  However, injury to iliac vessels 
and retrograde ejaculation has been reported.19, 31-34  Also, in many cases of degenerative 
disc disease, a decompression of the posterior neuroforamen is warranted, which would 
require a separate posterior procedure. 
 
The posterior interbody fusion approach allows the surgeon to address both anterior and 
posterior pathology through the same incision.  Using the posterior approach, bone grafts 
can be placed in the disc space via a translaminar or transforaminal approach.  The 
transforaminal approach allows the surgeon to avoid excessive nerve root and /or thecal 
sac retraction, which can lead to neural injury and postoperative fibrosis, and avoid 
excessive removal of posterior structures, which would lead to gross instability of the 
motion segment.19 
 
In 2001, over 122,469 lumbar fusions were performed nationwide for degenerative 
conditions.35  By 2005, it was estimated this number had increased to more than 300,000 
lumbar spine fusion being performed in the United States annually36.  Currently, industry 
research estimates that for 2014, approximately 75,000 minimally invasive posterior lumbar 
fusions performed domestically will utilize an interbody device with supplemental fixation. 
 
For interbody fusion with posterior fixation, spine surgeons currently place structural 
intervertebral spacers into the interbody space.  These spacers may be pre-shaped devices 
constructed of allograft (cortical bone dowels or femoral rings) or non-metallic, radiolucent 
materials (such as polyether ether ketone, PEEK), or metallic cage devices.  Autogenous 
bone graft and blood components (marrow, blood) are often added. 
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Use of morselized bone graft in orthopedic procedures is desirable because morselized 
graft is more rapidly incorporated during the course of bone healing.  If the morselized graft 
pack can be effectively contained in the interbody space, the graft material can function as 
a structural spacer to provide anterior column support.  Contained graft material can be 
tightly packed within the mesh to increase the graft’s compressive strength.  Unlike pre-
shaped cortical grafts, the morselized pack conforms intimately to the host bone at the 
surgical site, ensuring good vascularization potential and reducing the osteoblast jumping 
distance for osteogenesis.  In addition, the solidly packed graft retains intra-pack porosity, 
ensuring an osteoconductive scaffold to facilitate vascular and bony ingrowth. 
 
It would be desirable to minimize autograft use because of associated post-operative pain 
and morbidity, to optimize contact between allograft and host bone, and to permit the 
surgeon to place or construct an effective structural intervertebral spacer with only minimal 
neural retraction required. 
 
The SIFS is intended to be used to contain the bone graft placed by spine surgeons into 
the interbody space to achieve spinal intervertebral body fusion.  The SIFS mesh enables 
the use of morselized bone graft materials in spine fusion procedures instead of pre-
shaped materials, such as solid allograft cortical bone dowels or femoral rings, or rigid 
synthetic materials such as PEEK or titanium. 
 
In addition, the SIFS allows the surgeon to perform an interbody fusion through a small 
portal and to complete the entire fusion procedure from a posterior approach instead of a 
360 degree anterior/posterior procedure, which is often the case with the use of cages.  
The minimal access portal utilized for the SIFS mesh filling allows the device to be placed 
via a unilateral transforaminal or translaminar approach, versus the often-used bilateral 
approach required for many cages and cortical spacers.  This flexibility permits the surgeon 
to adapt the surgical approach to the local anatomy of the patient. 
 
1.1 
DEVICE DESCRIPTION 
 
The Spineology Interbody Fusion System (SIFS) consists of two components; the 
SIFS mesh device and the SIFS instruments. 
 
The Device – The SIFS mesh is a graft containment and reinforcement device.  The 
SIFS mesh is filled in situ with bone graft.  It is provided sterile and is a 
biocompatible, radiolucent, porous polyester mesh sack knitted from polyethylene 
terephthalate (PET) thread.  PET material is widely used to make surgical sutures 
and meshes.  The SIFS mesh device is pliable, conformable, and strong under 
tensile and burst forces as demonstrated through in vitro studies including axial 
compressive mechanical testing of the filled device’s load-bearing capabilities and 
overall segmental strength.  Beyond the mechanical testing, evaluation of the 
device was performed in an animal test model to further assess the biomechanical, 
radiographical and histological properties of the device.  Human clinical outcomes 
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have also been investigated under IDE G030106.  Refer to the SCOUT 
Investigational Plan for mechanical and biomechanical in vitro test protocols and 
results as well as in vivo outcomes. 
 
The Instruments – Following conventional thorough discectomy, the SIFS 
instruments allow the surgeon to finish the preparation of a large area of the disc 
space through a small portal in the annulus, introduce the SIFS mesh in its 
undeployed state into the prepared fusion bed cavity, and fill the mesh with bone 
graft.  The SIFS requires only minimal vascular and neural retraction during delivery 
of SIFS mesh and the graft material.  Utilizing the device specific instruments, the 
SIFS mesh is deployed and filled.  During the initial stages of mesh filling, the 
device expands and conforms to the cavity affording intimate graft apposition 
against the prepared vertebral endplates.  The porosity of the mesh cage permits 
direct contact between the graft and the bleeding host bone at the mesh pores.  As 
the density of contained graft increases within the mesh during the filling process, 
the graft may then distract the spinal segment.  By nature of the flexible fabric 
design, SIFS mesh allows complete filling of the prepared site with graft material 
while minimizing the risk of graft extravasation into the surrounding area. Graft 
containment reinforces the granular bone pack, making it capable of bearing load 
and increasing segmental stability. 
 
The SIFS received market clearance (K014200) on November 26, 2003 for 
containment of bone graft materials within the vertebral body.  In the present 
investigation, the SIFS mesh is considered investigational, for the current cleared 
labeling does not identify use of the SIFS mesh in an interbody fusion application as 
a cleared indication. 
 
1.2 
INTENDED USE 
 
The Spineology Interbody Fusion System is intended for use as an adjunct to fusion 
in instrumented lumbar fusion procedures for the treatment of degenerative disc 
disease.  The SIFS mesh component is intended to maintain the relative position of 
bone graft material.  The device is limited to use by or on the order of a physician. 
 
1.3 
INDICATIONS FOR USE 
 
The Spineology Interbody Fusion System is indicated for use in an intervertebral 
body fusion at one level in the lumbar spine from L2 to S1, in skeletally mature 
patients with degenerative disc disease (DDD) with up to a Grade I 
spondylolisthesis at the involved level.  In this investigation, DDD is defined as 
discogenic back pain with degeneration of the disc confirmed by patient history, 
examination and radiographic studies.  These patients shall have undergone six (6) 
months of conservative (non-operative) treatment.  The Spineology Interbody 
Fusion System with G2 Dry Mix allograft is intended for use with supplemental 
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posterior fixation systems cleared by FDA for use in the lumbar spine.  It is 
designed for use with autograft as an adjunct to fusion.  
 
Note:  G2 Dry Mix is an allograft mixture available from the Musculoskeletal 
Transplant Foundation (MTF), Edison, NJ.  G2 Dry Mix contains corticocancellous 
bone chips and demineralized bone matrix (DBM). 
 
1.4 
INSTRUCTIONS FOR USE 
 
Following a thorough discectomy and adequate preparation of the vertebral body 
endplates, the SIFS mesh is deployed within the prepared disc space, utilizing the 
SIFS instruments. The SIFS mesh is primarily filled with rehydrated G2 Dry Mix 
(granular human tissue allograft mixture), augmented with autograft and bone 
marrow aspirate.  The segmental construct is further stabilized with bilateral 
supplemental posterior fixation.  Only investigators trained in the use of the 
Spineology Interbody Fusion System may utilize the investigational device.  Refer to 
the SIFS Surgical Technique Manual (Appendix I) for complete instructions for use 
and implantation of the device. 
 
1.5 
CONTRAINDICATIONS AND CAUTIONS 
 
Use of the SIFS mesh is contraindicated in individuals with a known sensitivity to 
PET.   
 
G2 Dry Mix graft:  Trace amounts of Gentamicin, Primaxin and Amphotericin B 
antibiotics may be present. Trace amounts of Polysorobate-80, Ethanol, Methanol, 
Isopropanol, Polyoxyethylene (10) Phenol Ether and Hydrogen Peroxide may be 
present.  Caution should be exercised if the patient is allergic to any of these 
substances. 
 
 
 
 
 
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2.0 
PURPOSE AND INVESTIGATION OBJECTIVES 
2.1 
PURPOSE 
 
The purpose of this investigation is to evaluate the safety and effectiveness of the 
Spineology Interbody Fusion System in an instrumented lumbar interbody fusion. 
 
 
 
2.2 
INVESTIGATION OBJECTIVES 
 
The primary objective of this investigation is to demonstrate the effectiveness of the 
SIFS in a lumbar interbody application.  Effectiveness will be determined as a 
composite score that represents patient success.  To be considered a patient 
success, each of the following criteria must be met at the 24-month study interval: 
• 
Pain – Improvement in low back pain score evidenced by a 20 mm reduction 
on a 100 mm Visual Analog Scale (VAS) when compared to baseline (Note:  
a lower VAS pain score indicates less pain), 
• 
Function – Improvement in low back function evidenced by a 15 point 
decrease of the Oswestry Disability Index (ODI) score compared to baseline.  
(Note:  a higher ODI score indicates a greater disability with respect to low 
back function), 
• 
Fusion – Bridging bone demonstrated on CT Scan 
• 
Safety – Freedom from device-related Serious Adverse Events and 
secondary surgical interventions at the index level through the 24-month 
study interval. 
 
In additional to the above stated primary objective, this investigation will yield data 
on the following outcomes, subject parameters and clinical utility: 
• 
Variable scores over time (pain, function, fusion) as individual parameters 
• 
Adverse Event rate(s) reported by relatedness and severity 
• 
Neurological status over time 
• 
Quantitative/qualitative radiographic data over time specific to the index level 
and contiguous levels (translation, angulation, disc height, and device 
position) 
• 
Demographics 
• 
Hospitalization Utility (duration of surgery, estimated blood loss and duration 
of hospitalization) 
• 
Work status over time 
• 
Pain medication use 
 
Data collection is not limited to the above data points.  Additional parameters will be 
reported on as appropriate.  For a more detailed list of supplemental outcomes refer 
to Section 3.2 Scientific Soundness and Statistical Analysis. 
 
 
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2.3 
STUDY DURATION 
 
This study will conclude when the final study subject has achieved their 24-month 
study evaluation.  While the primary endpoints for this trial are defined at 24 months 
post-operative, this investigation will include annual subject self-assessment follow-
ups at 36 months and 48 months post-operative while study enrollment is ongoing.  
This means that subjects enrolled into this investigation are expected to achieve a 
final (physical) study examination that includes imaging and neurological testing 
approximately 24-months after their index procedure.  Following the 24-month 
physical evaluation and testing that supports primary endpoint analysis, subjects 
are expected to complete a self-assessed Patient Survey Form and a Long-Term 
Follow-Up Questionnaire at the 36-month and 48-month timepoint as appropriate 
until the final study subject has completed study participation at the 24-month 
timepoint.  Therefore, while a subject’s active participation (physical 
examination/testing) may conclude at 24-months post-op, their study participation 
may extend to include longer-term remote follow-up to a maximum of 48-months 
post-operative resultant of the potential for the self-administered 
survey/questionnaire completion. 
 
It is anticipated that the enrollment phase of this investigation shall be complete 
within approximately eighteen (18) to twenty-four (24) months (1.5 to 2 years) of 
initiation and that the overall study shall conclude in approximately 42-months (3.5 
years) to 48-months (4 years) based on the following estimations: 
• 
Although the study is approved to be conducted at a maximum of 15 
investigative sites, ideally, the study shall be conducted at approximately 10 
of the 15 investigative sites. 
• 
It is anticipated that a full patient complement (enrollment) will consist of no 
more than 102 subjects. 
• 
Each investigative site is expected to enroll approximately 10 subjects (.85 
subjects per month/10 subjects per year yielding an anticipated total 
enrollment duration of 12 months per site. It is recognized that should 
enrollment be protracted, it may potentially require up to 18 months (1.5 
years) to enroll the complete cohort. 
• 
Allowing for staged site activation (2 - 3 sites per month x 10 sites), it is 
anticipated the cumulative duration of enrollment would be approximately 18 
months to 24 months. 
• 
Accounting for the 24-month follow-up, it is anticipated the total study 
duration will be between 42-months (3.5 years) and 48-months (4 years) 
from initiation to closure.  
 
 
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3.0 
INVESTIGATION DESIGN 
3.1 
OVERVIEW AND GENERAL DESIGN 
 
This is a FDA regulated, prospective, non-randomized, single treatment arm, 
multicenter, IRB approved performance goal investigation designed to evaluate the 
safety and effectiveness of the SIFS mesh device when implanted in the 
intervertebral body disc space with bone graft during an instrumented lumbar fusion 
procedure.  Enrolled subjects will be evaluated for device safety and effectiveness 
outcomes that support primary endpoint analysis through the 24-month time point.  
As previously noted in the protocol, study subjects will be expected to complete a 
self-administered survey annually through a maximum of 48 months post-operative 
as necessary until the last study subject has concluded study participation.  Data 
from this investigation will be used to support a regulatory submission (e.g., De 
novo petition). 
 
This non-randomized investigation will examine the primary endpoint and numerous 
additional outcomes.  A Data Monitoring Committee will be established for this trial 
and shall oversee trial conduct to ensure the safety and protection of study 
participant rights and welfare.  An independent core lab will be utilized to perform 
fusion assessments and radiologic measurements. 
 
3.2 
SCIENTIFIC SOUNDNESS AND STATISTICAL ANALYSIS 
 
The safety and effectiveness of the SIFS will be evaluated utilizing standard 
statistical practices and principles.   
 
3.2.1 Primary Endpoint 
 
The primary endpoint (success) is a composite endpoint of pain, function, 
fusion, and safety, defined as meeting each of the following criteria at the 
24-month study interval: 
• 
Pain – Improvement in low back pain score evidenced by a 20 mm 
reduction on a 100 mm Visual Analog Scale (VAS) when compared 
to baseline (Note:  a lower VAS pain score indicates less pain), 
• 
Function – Improvement in low back function evidenced by a 15 point 
decrease of the Oswestry Disability Index (ODI) score compared to 
baseline.  (Note:  a higher ODI score indicates a greater disability 
with respect to low back function), 
• 
Fusion – Bridging bone demonstrated on CT Scan 
• 
Safety – Freedom from investigational device-related Serious 
Adverse Events at the index level through the 24-month study 
interval. 
 
 
 
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3.2.2 Additional Outcomes 
 
Beyond supporting the primary endpoint of this investigation, Spineology is 
evaluating additional outcome data.  The investigation design allows for the 
assessment of objective and subjective findings.  Descriptive data will be 
provided to characterize these additional effectiveness and safety measures: 
• 
Mean low back VAS pain score over time through the 24-month 
interval 
• 
Mean lower extremity (right and left leg) VAS scores over time 
through the 24-month interval 
• 
Mean ODI score over time through the 24-month interval 
• 
Fusion at the 12-month and the 24-month interval 
• 
Occurrence of device-related Serious Adverse Events through the 
24-month interval 
• 
Occurrence of study-related Adverse Events through the 24-month 
interval 
• 
Neurological status assessment (strength, sensation, and reflexes) 
over time through the 24-month interval (reporting categorized as 
improved, maintained, or reduced with new or increased neurological 
deficit being further categorized as transient (< 3 months/90 days) or 
longer term ≥ 3 months/90 days);  
• 
Radiographic data observed over time specific to the index level 
(translation, angulation, disc height, and device position) 
• 
Subject satisfaction with procedure/outcome 
• 
Work status over time 
• 
Pain medication use over time 
• 
Operative time 
• 
Estimated blood loss 
• 
Duration of hospitalization 
• 
Graft site pain (as applicable) 
• 
Adjacent segment status at 24-months post-operative assessed by 
quantitative and qualitative radiographic data (translation, angulation, 
and disc height) 
 
3.2.3 Statistical Methods   
 
The statistical analysis of the data obtained from this study will be performed 
using SAS® version 9.1 or higher.  All statistical tests will be performed at the 
0.05 significance level, unless otherwise indicated. 
 
Data collected in this study will be documented using summary tables and 
subject data listings. Continuous variables will be summarized using 
descriptive statistics, specifically the mean, median, standard deviation, 
minimum, and maximum, and a 95% confidence interval for the mean based 
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on the t-distribution. Categorical variables will be summarized using 
frequencies and percentages and 95% exact (Clopper-Pearson) confidence 
intervals for the true proportions. 
 
All analyses of effectiveness and safety will be based upon the Treated 
Population defined to be all treated subjects. 
 
3.2.4 Determination of Sample Size 
 
The required sample size was calculated based on the following 
specifications: 
 
1. Endpoint: success rate 
2. One-sided exact binomial test for a binomial proportion 
3. Alpha = 0.05 
4. True percentage of successes = 68% 
5. Performance Goal (null percentage of successes) = 55% 
6. Power = 80% 
 
The required sample size based upon these specifications is 87 subjects. 
The sample size was increased to 102 subjects to take into account an 
assumed 15% lost to follow-up rate.   
 
3.2.5 Sample Size Re-Estimation 
 
A sample size re-estimation will be performed based on 12-month interim 
data. 
 
3.2.6 Analysis of Primary Endpoint 
 
The primary endpoint for this investigation is a composite endpoint of pain, 
function, fusion, and safety that meets all of the following criteria at the 24-
month study interval: 
• 
Pain – Improvement in low back pain score evidenced by a 20 mm 
reduction on a 100 mm Visual Analog Scale (VAS) when compared 
to baseline (Note:  a lower VAS pain score indicates less pain), 
• 
Function – Improvement in low back function evidenced by a 15 point 
decrease of the Oswestry Disability Index (ODI) score compared to 
baseline.  (Note:  a higher ODI score indicates greater disability with 
respect to low back function), 
• 
Fusion – Bridging bone demonstrated on CT Scan 
• 
Safety – Freedom from investigational device-related Serious 
Adverse Events at the index level through the 24-month study 
interval. 
  
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This endpoint will be summarized using the count and percentage, together 
with a 95% exact (Clopper-Pearson) confidence interval for the true 
proportion of successes. The null and alternative hypotheses for this 
endpoint are as follows:  
 
 
H0: p ≤ 0.55  
  
    versus  
 
H1: p > 0.55 
  
where p denotes the true proportion of subjects achieving success for this 
endpoint. The null hypothesis will be tested using a 1-sided exact binomial 
test for a binomial proportion conducted at the 0.05 level of significance.  
 
Missing values for the primary endpoint at Month 24 will be imputed using 
the last-observation-carried-forward (LOCF) method and multiple imputation 
methods. For subjects who are missing at most one component of the 
primary endpoint at Month 24 and who have a value for the given 
component at Month 12, the LOCF method will be used to impute a value for 
that component at Month 24, so that the value of the primary endpoint at 
Month 24 can then be determined. Once the LOCF procedure has been 
performed, multiple imputation methods will be used to impute values for the 
remaining subjects with missing values for the primary endpoint at Month24. 
The imputation procedure will be based on primary endpoint data at all 
previous post-baseline time points. 
 
3.2.7 Analysis of Additional Outcomes 
 
The additional outcomes for this study are as follows: 
 
• 
Mean low back VAS pain score over time through the 24-month 
interval 
• 
Mean lower extremity (right and left leg) VAS scores over time 
through the 24-month interval 
• 
Mean ODI score over time through the 24-month interval 
• 
Fusion at the 12-month and the 24-month interval 
• 
Occurrence of device-related Serious Adverse Events through the 
24-month interval 
• 
Occurrence of study-related Adverse Events through the 24-month 
interval 
• 
Neurological status assessment (strength, sensation, and reflexes) 
over time through the 24-month interval (reporting categorized as 
improved, maintained, or reduced with new or increased neurological 
deficit being further categorized as transient (< 3 months/90 days) or 
longer term ≥ 3 months/90 days);  
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• 
Radiographic data observed over time specific to the index level 
(translation, angulation, disc height, and device position) 
• 
Subject satisfaction with procedure/outcome 
• 
Work status over time 
• 
Pain medication use over time 
• 
Operative time 
• 
Estimated blood loss 
• 
Duration of hospitalization 
• 
Graft site pain (as applicable) 
• 
Adjacent segment status at 24-months post-operative assessed by 
quantitative and qualitative radiographic data (translation, angulation, 
and disc height) 
 
The mean low back pain score over time through the 24-month interval will 
be summarized using descriptive statistics and a 95% confidence interval 
based upon the t-distribution. The mean lower extremity (right and left leg) 
VAS scores over time and the mean ODI score over time will be analyzed in 
the same manner. 
 
The number and percentage of subjects achieving fusion at the 12-month 
and 24-month intervals and the corresponding 95% exact (Clopper-Pearson) 
confidence intervals for the true proportion of subjects achieving fusion will 
be presented. 
 
The number and percentage of subjects with any device-related serious 
adverse events (SAEs) and with any study-related adverse events will be 
presented, together with 95% exact (Clopper-Pearson) confidence intervals 
for the true proportions. AEs will be summarized at the subject level by type 
of event using frequencies and percentages. AEs will also be tabulated at 
the event level by severity and by relatedness. 
 
Neurological status for strength, sensation, and reflexes will be summarized 
by time point using counts and percentages and 95% exact (Clopper-
Pearson) confidence intervals for the true proportions.  
 
Radiographic data for translation, angulation, and disc height specific to the 
index level will be summarized by time point using descriptive statistics and 
a 95% confidence interval based upon the t-distribution.  Device position will 
be summarized by time point using counts and percentages and 95% exact 
(Clopper-Pearson) confidence intervals for the true proportions. 
 
Subject satisfaction with the procedure/outcome will be summarized using 
counts and percentages and 95% exact (Clopper-Pearson) confidence 
intervals for the true proportions. 
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Operative time, estimated blood loss, and duration of hospitalization will be 
summarized using descriptive statistics and a 95% confidence interval 
based upon the t-distribution. Work status, pain medication use, and graft 
site pain will be summarized by time point using frequencies and 
percentages and 95% exact (Clopper-Pearson) confidence intervals for the 
true proportions.  
 
Radiographic data at 24-months post-operative for translation, angulation, 
and disc height for treated and adjacent segments will be summarized using 
descriptive statistics and a 95% confidence interval based upon the t-
distribution. 
   
For the analyses of these additional outcomes, there will be no imputation of 
missing values. 
 
3.2.8 Data Management Plan 
 
The purpose of a Data Management Plan (DMP) is to provide guidance for 
all aspects of data management as it pertains to this investigation.  A DMP 
shall be in place prior to the initiation of this clinical investigation. 
 
3.2.9 Subject Withdrawal 
 
An enrolled subject is considered “withdrawn” from the investigation if their 
participation in the study is discontinued for any reason after signing the 
consent form.  If a subject chooses to withdraw from the investigation, a 
Subject Discontinuation CRF will be completed and submitted to the sponsor 
as soon as it is practical.  Every effort will be made to complete the trial 
CRFs applicable up to the point of withdrawal.  If a subject voluntarily 
withdraws from the investigation, the data generated from their participation 
in the study will still be used in the overall investigation data set.  Approval to 
use the data will be documented in the consent form.   
 
Subjects who have not voluntarily withdrawn from the investigation, but fail 
to return for follow-up visits, will be considered “Lost-to-Follow-Up” (LTFU).  
Subjects identified as LTFU will be withdrawn from the investigation through 
completion of a Subject Discontinuation Form.  Prior to formally 
discontinuing a subject from the investigation for being LTFU, multiple efforts 
shall be made including supplemental attempts to contact the subject.  As an 
example, supplemental efforts may include 3 attempts to reach this subject 
(2 by telephone and 1 by certified letter).  All supplemental attempts to reach 
a potential LTFU subject shall be documented in writing. 
 
 
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3.2.10  Control Subject Population 
 
The SCOUT IDE Investigation is a single-arm clinical trial.  Accordingly, a 
control study population is not undertaken for this investigation as each 
study subject essentially functions as their own control in terms of outcome 
parameters over time. 
 
3.2.11 Randomization 
 
This is NOT a randomized investigation.  All enrolled study subjects shall be 
treated with the investigation device (SIFS mesh). 
 
3.2.12 Minimization of Bias 
 
To minimize the introduction of bias into this clinical investigation, the 
following measures will be observed: 
• 
All investigation participants shall be enrolled under the same 
inclusion/exclusion criteria, 
• 
All investigation participants shall follow the same study protocol, 
• 
Adverse event adjudication will be performed by an objective Data 
Monitoring Committee panel. 
 
The study entrance criteria for this investigation are designed to 
accommodate enrollment of a study population that would closely match the 
intended patient population for the device.  Following determination that a 
subject is eligible for study participation and the approved Informed Consent 
Form (ICF) for the investigative site is signed, a subject is considered 
enrolled into the SCOUT clinical investigation.  All study subjects will receive 
the investigational treatment device (SIFS mesh).   
 
 
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4.0 
SELECTION OF SUBJECTS 
To participate in this clinical investigation, a subject shall meet the study entrance criteria.  
This means that at the time of screening, a subject shall meet all of the inclusion criteria 
and none of the exclusion criteria.   
 
4.1 
INVESTIGATION POPULATION 
 
Candidates for this investigation shall be skeletally mature, presenting with painful 
lumbar degenerative disc disease at a single level from L2 to S1.  Subjects may 
have up to a Grade I spondylolisthesis at the index (involved) level.  For this 
investigation, DDD is defined as discogenic back pain with degeneration of the disc 
confirmed by patient history, examination and radiographic studies.  Study subjects 
shall present with low back pain.  These subjects are to have been treated with 
conservative (non-surgical) measures for a minimum of six (6) months without 
achieving sufficient relief from their symptoms.  The investigator is responsible for 
determining subject eligibility per the defined investigation inclusion and exclusion 
criteria. 
 
4.2 
INCLUSION CRITERIA 
 
To participate in this investigation, a study subject shall meet all of the following 
inclusion criteria: 
• 
Minimum age of twenty-one (21) years but not greater than eighty (80) years; 
• 
Skeletally mature; 
• 
Have a confirmed diagnosis of lumbar degenerative disc disease requiring 
single-level fusion between L2 and S1.  Lumbar DDD diagnosis confirmation 
shall be determined by subject history, physical examination, and 
radiographic studies with one or more of the following factors: 
- 
Instability as defined by >3mm translation or ≥ 5° angulation; 
- 
Osteophyte formation of facet joints or vertebral endplates; 
- 
Decreased disc height, on average by > 2mm, but dependent upon 
the spinal level; 
- 
Scarring/thickening of the ligamentum flavum, annulus fibrosis, or 
facet joint capsule; 
- 
Herniated nucleus pulposus; 
- 
Facet joint degeneration/changes; and/or 
- 
Vacuum phenomenon; 
• 
Report pre-operative low back pain score of ≥ 40mm on a 100mm Visual 
Analog Scale (VAS) correlating with involved level; 
• 
Report pre-operative Oswestry Disability Index (ODI) score of ≥ 40; 
• 
Received at least 6 months of conservative (non-surgical) treatment without 
sufficient relief from symptoms; 
• 
Willing and able to comply with follow-up evaluations per protocol, including 
completion of self-assessment survey questionnaire(s), and has read, 
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understood and signed the sponsor and IRB approved site-specific informed 
consent form. 
 
4.3 
EXCLUSION CRITERIA 
 
In the event a subject meets one or more of the following exclusion criteria, they 
shall be excluded from study participation: 
• 
Previous implant surgery (i.e., fusion procedure or total disc replacement) at 
the index level (Note: Previous less invasive procedures such as 
laminectomy, discectomy, etc., at the index level are not considered 
exclusionary); 
• 
Greater than Grade I spondylolisthesis; 
• 
Presents with a diagnosis of symptomatic non-index level lumbar 
degenerative disc disease between L2 and S1.  Non-index level lumbar DDD 
diagnosis confirmation shall be determined by subject history, physical 
examination, and radiographic studies with one or more of the following 
factors: 
- 
Instability as defined by >3mm translation or ≥ 5° angulation; 
- 
Osteophyte formation of facet joints or vertebral endplates; 
- 
Decreased disc height, on average by > 2mm, but dependent upon 
the spinal level; 
- 
Scarring/thickening of the ligamentum flavum, annulus fibrosis, or 
facet joint capsule; 
- 
Herniated nucleus pulposus; 
- 
Facet joint degeneration/changes; and/or 
- 
Vacuum phenomenon; 
• 
Active systemic infection or infection local to the surgical site; 
• 
Active or suspected malignancy; 
• 
Body Mass Index (BMI) of ≥ 40; 
• 
Significant metabolic bone disease (e.g., osteoporosis or osteomalacia) to a 
degree that would contraindicate spinal instrumentation.  Osteoporosis is 
defined as a T-score of < -2.5 on a DEXA scan.  A screening questionnaire 
for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimate), 
will be administered to identify those patients that require a DEXA scan (a 
score greater than or equal to 6 requires DEXA scan); 
• 
Taking medications that are known to potentially interfere with bone or soft 
tissues healing (e.g., chronic systemic steroids); 
• 
Has a current diagnosis of substance related disorder, as defined per the 
Diagnostic and Statistical Manual of Mental Disorders 5th Edition, May 2013 
(DSM – V); 
• 
Has a diagnosis of somatoform, dissociative, eating or psychotic disorder per 
DSM – V; 
• 
Waddell Signs of inorganic behavior (3 or more signs); 
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• 
Is a current tobacco user (current use defined as tobacco use ≤ 30 days prior 
to surgery); 
• 
Is a prisoner at the time of enrollment; 
• 
If female: pregnant/contemplating pregnancy during the follow-up period; 
• 
Enrolled in a concurrent clinical investigation that may confound the findings 
of the present investigation.  
 
Waddell Signs constitute a test methodology that evaluates for inorganic problems.  
Waddell Signs are findings that deviate from the usual presentation of a disease.  
Waddell identified five (5) types of signs: Tenderness, Simulation, Distraction, 
Regional Disturbance and Overreaction.  During the subject evaluation, the 
Investigator should note any observed signs of inorganic behaviors displayed by the 
subject.   If a subject has three (3) or more inorganic behaviors, they do not meet 
the study entrance criteria and should be excluded from clinical trial participation.  A 
description of Waddell Signs is provided as Appendix II. 
 
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Doc #62-180, Rev A_25Aug2014                                                                                                                                        Page 21 of 53 

5.0 
TREATMENT 
5.1 
INVESTIGATIONAL PRODUCT  
 
Each SIFS mesh device package is labeled in accordance with federal regulation 
(21 CFR §812.5(a)) “Caution – Investigational device.  Limited by United States law 
to investigational use”.  Beyond the cautionary labeling, each device package is 
labeled with a lot number.  The lot number, along with the date of use, disposition, 
etc., will be captured on the appropriate study-related case report form.  The SIFS 
investigational device package labeling is provided as Appendix III.  Investigational 
product will be provided only to investigation sites determined qualified and 
approved by Spineology Clinical Affairs to receive the device.  To qualify for 
investigational product receipt, a site must have obtained IRB approval, have a fully 
executed clinical trial agreement, meet all administrative requirements, and be 
trained in the investigation protocol and study conduct. 
 
5.2 
DESCRIPTION OF PROCEDURE 
Standard posterior techniques for exposure of spinal elements will be employed.  
The surgical approach to the intervertebral disc space may be open or minimally 
invasive, translaminar (midline to mid-pedicular line; PLIF), or transforaminal (lateral 
to mid-pedicular line; TLIF).  Following completion of a thorough discectomy and 
sufficient decortication/denuding of the vertebral endplates to expose bleeding 
bone, the SIFS mesh is deployed using a minimally invasive surgical access.  A 
working cannula is guided into the intervertebral disc space.  The cannula provides 
an access pathway for use of the remaining surgical instruments.  To ensure proper 
disc space preparation, four Spineology discectomy tools must also be utilized prior 
to implantation of the SIFS mesh device.  The compulsory tools are: 
• 
Shaper – shaves through the central endplate cartilage, to expose bleeding 
bone; 
• 
BackHoe – loosens disc material, curettes off endplate cartilage; 
• 
Disc Brush – removes any remnants of disc left behind by curettes and other 
tools; and 
• 
Verify – confirms depth and breadth of discectomy. 
 
The prepared disc space cavity is cleared with suction and the SIFS mesh device is 
introduced through the cannula.  The implant is filled within the disc space with the 
G2 Dry Mix graft mixture freshly inserted into the placement tube.  Utilizing a 
rotational deployment technique for the introduction of the graft, the SIFS mesh 
device is evenly packed until sufficient height and disc space conformance is 
achieved. No additional bone graft (i.e., “sentinel graft”) is placed within the disc 
space. 
 
Supplemental fixation is placed to stabilize the intervertebral construct utilizing the 
recommended manufacturer’s technique.  No posterolateral (dorsal) grafting may be 
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applied.  This protocol allows for utilization of the following commercially available 
supplemental rigid posterior fixation instrumentation systems: 
• 
Expedium® and Viper® Systems, DePuy Synthes, (multiple clearances, 
including K110216), or 
• 
Fortress™ Pedicle Screw System, Spineology, Inc. (K140010). 
 
A complete description of the surgical procedure for device implantation is provided 
in the SIFS Surgical Technique Manual as Appendix I. 
 
5.3 
ASSESSMENTS AND PATIENT CARE 
 
5.3.1 Screening and Enrollment 
 
Prior to enrollment into this investigation, subjects shall be screened for 
potential inclusion.  Subjects who undergo screening but do not meet the 
study entrance criteria are considered screen failures.  Screen failures are 
documented on the Screening Log.  Subjects meeting all study entrance 
criteria may be enrolled and treated.  Enrolled subjects are to be followed in 
accordance with the study protocol through a maximum of 48-months 
postoperative (active visits through the 24 months postoperative; remote 
longer-term follow-up self-administered questionnaires at 36 months and 48 
months post-op as necessary and appropriate until the last subject enrolled 
has achieved their final exam at 24-months postoperative).  Once a subject 
has achieved their final assessment based on the above parameters, the 
subject’s participation in this trial is complete.   
 
5.3.2 Study Interval Evaluations 
 
Intervals – Following enrollment into this investigation, subjects are followed 
periodically over time with pre-specified data being obtained at designated 
intervals.  Subjects are actively assessed (i.e., includes physical 
examination and testing) prior to receiving the study treatment (baseline), 
through the surgical procedure and discharge from the hospital, at 6-weeks 
post-operative and at 3-, 6-, 12-, and 24-months post-operative.  Beyond the 
above active assessment intervals performed in the health practitioner’s 
setting, subjects shall undergo longer-term remote assessment in the form 
of completion of self-administered surveys/questionnaires.  The longer-term 
patient survey/questionnaire forms shall be completed at the 36- and 48-
month interval until the final study subject has achieved their 24-month study 
evaluation.  Table 1 indicates the subject evaluation time points and the 
correlating assessments to be performed at each study interval.   
 
X-rays – Study radiographs shall be performed weightbearing (WB) and 
utilizing a magnification marker, allowing core lab assessments to adjust for 
magnification discrepancies and ensuring measurement accuracy over time.  
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The study specific magnification marker shall be provided by the sponsor to 
investigation sites.  X-rays are performed at each active study visit through 
the 24-month interval. 
 
Adverse Event Assessment – Beginning with the surgery/hospital interval 
and for each subsequent post-operative interval through study conclusion, 
subjects shall be assessed for adverse event (AE) occurrence, resolution, or 
status update.   
 
Post-Operative Instruction – It is acknowledged that individual post-operative 
care plans are tailored to the specific subject by the treating investigator, 
however the following post-operative care plan is provided to assist in the 
standardization of care provided across investigative sites: 
• 
Avoid driving for a minimum of 1 week following discharge.   
• 
Avoid driving while on pain medication. 
• 
Ambulate as soon as it is comfortable. 
• 
Observe the following lifting restrictions: 
- Less than 10 pounds for 2 to 4 weeks post-op. 
- Less than 20 pounds through 12 weeks post-op. 
• 
Limit bending and twisting for a minimum of 4 weeks post-op. 
• 
Use of a lumbar support brace is optional. 
     
Table 1: Study Intervals and Data Collection Requirements 
Assessment 
Baseline  
Surgery 
& Hosp. 
6-Week 
42 days  
(± 7 days)  
3-Month 
90 days  
(± 14 days) 
6-Month 
180 days  
(± 30 days) 
12-Month 
365 days  
(± 45 days) 
24-Month 
730 days  
(± 60 days) 
36-Month & 
48-Month 
as applicable  
(1095 & 1460 
days ± 60 
days each) 
Inclusion/Exclusion 
X 
- 
- 
- 
- 
- 
- 
- 
Informed Consent 
X 
- 
- 
- 
- 
- 
- 
- 
Pain Medication Use 
X 
- 
X 
X 
X 
X 
X 
- 
Neurological 
Examination 
X 
X 
X 
X 
X 
X 
X 
- 
Surgery/Hospitalization 
- 
X 
- 
- 
- 
- 
- 
- 
Patient Surveyᵻ 
X 
- 
X 
X 
X 
X 
X 
X 
Work Status 
X 
- 
X 
X 
X 
X 
X 
- 
MRI or other imaging 
study‡ 
X 
- 
- 
- 
- 
- 
- 
- 
Weightbearing AP X-ray 
X 
X 
X 
X 
X 
X 
X 
- 
Weightbearing NL X-ray 
X 
X 
X 
X 
X 
X 
X 
- 
Weightbearing Flex/Ext 
X-rays 
X 
- 
- 
- 
X 
X 
X 
- 
CT scan 
- 
- 
- 
- 
- 
X 
X 
- 
Adverse Event 
Assessment 
- 
X 
X 
X 
X 
X 
X 
- 
Patient Questionnaire 
- 
- 
- 
- 
- 
- 
- 
X 
ᵻPatient Survey consists of VAS (low back, lower extremities, and iliac crest as applicable), ODI, SF-36 Health Survey and subject 
satisfaction. 
‡As defined per protocol. 
Performed only if determined to be not fused per CT scan at the 12-month interval 
 
 
 
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5.3.3 Baseline / Pre-Procedure Study Interval – Active Assessment 
(≤ 3 months of investigational treatment date) 
 
The following forms/assessments are required to be completed at this 
interval: 
• 
Screening Log (enrolled subjects and screen failures) 
• 
Informed Consent  
• 
Patient Survey  
• 
Pre-Operative Evaluation 
• 
Neurological Assessment 
• 
Pain Medication Log 
• 
Radiographs:  Weightbearing AP, neutral lateral, flexion and 
extension views 
• 
MRI or other appropriate imaging per protocol 
 
 
5.3.4 Surgery / Hospitalization Study Interval – Active Assessment 
 
The following forms/assessments are required to be completed at this 
interval: 
• 
Surgery/Hospitalization  
• 
Neurological Assessment 
• 
Radiographs:  Weightbearing AP and neutral lateral, at discharge 
 
5.3.5 Six (6) Week Study Interval – Active Assessment 
(42 days ± 7 days) 
 
The following forms/assessments are required to be completed at this 
interval: 
• 
Patient Survey  
• 
Follow-Up Evaluation 
• 
Neurological Assessment 
• 
Pain Medication Log 
• 
Radiographs:  Weightbearing AP and neutral lateral 
 
 
5.3.6 Three (3) Month Study Interval – Active Assessment 
(90 days ± 14 days) 
 
The following forms/assessments are required to be completed at this 
interval: 
• 
Patient Survey  
• 
Follow-Up Evaluation 
• 
Neurological Assessment 
• 
Pain Medication Log 
• 
Radiographs:  Weightbearing AP and neutral lateral 
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5.3.7 Six (6) Month Study Interval – Active Assessment 
(180 days ± 30 days) 
 
The following forms/assessments are required to be completed at this 
interval: 
• 
Patient Survey  
• 
Follow-Up Evaluation 
• 
Neurological Assessment 
• 
Pain Medication Log 
• 
Radiographs:  Weightbearing AP and neutral lateral 
 
 
5.3.8 Twelve (12) Month Study Interval – Active Assessment  
(365 days ± 60 days) 
The following forms/assessments are required to be completed at this 
interval: 
• 
Patient Survey  
• 
Follow-Up Evaluation 
• 
Neurological Assessment 
• 
Pain Medication Log 
• 
Radiographs:  Weightbearing AP, neutral lateral, flexion and 
extension views 
• 
CT scan 
 
5.3.9 Twenty-four (24) Month Study Interval – Final Active Assessment  
(730 days ± 60 days) 
The following forms/assessments are required to be completed at this 
interval: 
• 
Patient Survey  
• 
Follow-Up Evaluation 
• 
Neurological Assessment 
• 
Pain Medication Log 
• 
Radiographs:  Weightbearing AP, neutral lateral, flexion and 
extension views 
• 
CT scan (performed only if determined not fused per CT scan at the 
12-month interval) 
 
5.3.10 Thirty-Six (36) Month Study Interval – Remote Assessment  
(1095 days ± 60 days) 
The following forms/assessment are required to be completed at this interval 
until the last subject enrolled in the trial has completed their 24-month exam: 
• 
Patient Survey  
• 
Long-Term Follow-Up Questionnaire 
 
 
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5.3.11 Forty-Eight (48) Month Study Interval – Remote Assessment  
(1460 days ± 60 days) 
The following forms/assessment are required to be completed at this interval 
until the last subject enrolled in the trial has completed their 24-month exam: 
• 
Patient Survey  
• 
Long-Term Follow-Up Questionnaire 
 
6.0 
RADIOGRAPHIC EVALUATIONS 
Radiographic evaluations (x-rays) are to be performed in accordance with the study 
protocol.  All x-rays are to be performed weightbearing (standing).  Anterior/Posterior (AP) 
and Neutral Lateral (NL) X-rays are taken preoperatively and are repeated prior-to-
discharge from the hospital and at the 6-week, 3-, 6-, 12-, and 24-month post-operative 
visits. The prior-to-discharge weight-bearing AP and neutral lateral X-ray will serve as the 
baseline postoperative assessment of disc space height.  Lateral Flexion/Extension X-rays 
are taken preoperatively and repeated at the 6-, 12- and 24-month post-operative visits to 
document the preoperative condition of the involved disc space and to evaluate stability 
and fusion of the operative level during follow-up.  X-rays shall be obtained with a study-
specific magnification marker in place.  The marker allows the core lab to adjust for 
magnification discrepancies and ensure measurement accuracy.  Further, to help assure 
accurate reporting of quantitative sagittal alignment by lumbar segment in this 
investigation, neutral lateral radiographs shall adequately display the vertebral 
bodies from T-12 through S1.   
A CT scan will be performed at the 12-month study interval.  In the event a subject is 
determined “not fused” at the 12-month timepoint per the CT scan assessment, a second 
CT scan would be performed at the 24-month post-op interval. Table 2 below indicates the 
per protocol radiographic schedule. 
 
   Table 2:  Radiographic Assessment Schedule 
 
Pre 
operative  
Post 
operative  
6 
week 
3 
month 
6 
month 
12 
month 
24 
month 
MRI (T2 weighted image) ᵻ 
X 
 
 
 
 
 
 
Standing AP  
X-rays 
X 
X 
X 
X 
X 
X 
X 
Standing NL  
X-rays 
X 
X 
X 
X 
X 
X 
X 
Lateral flexion-extension 
films 
X 
 
 
 
X 
X 
X 
CT Scan 
 
 
 
 
 
X 
X 
   ᵻOr other appropriate radiologic study as defined per protocol. 
    Performed only if determined to be not fused per CT scan at the 12-month interval 
 
 
 
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The following radiographic analyses are planned: 
Radiographic assessment for bridging bone will be completed by two board-certified 
radiologists. A third radiologist will provide a “tie-breaker” reading if needed.  Radiologist 
evaluations will be centralized for films from all investigational sites. 
 
Fine-cut CT images with sagittal and coronal reconstructions will be used as the primary 
determinant of fusion status.  X-ray images will also be subjected to a qualitative 
assessment to evaluate for the presence of bridging bone. 
 
Follow-up x-rays will be evaluated by an independent radiographic core laboratory. For this 
trial, the core lab will measure relative angulation and translation of the vertebral bodies at 
the involved motion segment during flexion/extension motion, and will also measure both 
anterior and posterior disc space height.  The core lab will further evaluate for device 
condition/configuration and position changes over time. 
 
Imaging will be reviewed by the radiologist/core lab for the presence of any of the following 
negative conditions: 
• 
Expulsion:  Implant moved outside of disc space  
• 
Migration: 
> 5 mm migration of implant from original position  
• 
Subsidence: > 5 mm loss of disc height  
• 
Significant Radiolucency:  > 50% of implant/endplate interface shows true lucency 
(true lucency is black, not gray)  
• 
Adjacent level disc degeneration, defined as: 
- 
> 5mm loss of disc height  
- 
> 3mm translation on flexion/extension  
• 
Loosening and/or breakage of pedicle screws 
 
The radiographic assessment protocol, film labeling instructions, and other radiographic 
reference material are included in Appendix IV.   
 
 
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7.0 
BENEFIT / RISK ANALYSIS 
 
7.1 
BENEFITS 
 
In this investigation there may or may not be a direct benefit to the subject for study 
participation.  Potential direct benefits may include but are not limited to: 
• 
Stabilization of the spine as an adjunct to bony fusion 
• 
Restoration of the disc space which may lead to immediate symptom relief 
• 
Reduction of low back and/or leg pain and other associated symptoms 
• 
Improved function of the low back 
 
An indirect benefit to subject participation in this investigation is that it may lead to 
future improvements in the treatment of lumbar degenerative disc disease and help 
to relieve lumbar DDD associated symptoms in other patients suffering from this 
condition. 
 
7.2 
RISKS 
 
7.2.1 SIFS Mesh Risks 
The potential risks associated with the study device include but are not 
limited to: 
• 
Mesh disruption (tear) 
• 
Device migration 
• 
Allergic reaction to PET 
 
7.2.2 MTF G2 Dry Mix Graft Risks 
The potential risks associated with the Graft Mix include but are not limited 
to: 
• 
Disease or infection from use of human tissue, and allergic reaction 
to trace substances including Gentamicin, Primaxin and 
Amphotericin B antibiotics and Polysorobate-80, Ethanol, Methanol, 
Isopropanol, Polyoxyethylene (10) Phenol Ether and Hydrogen 
Peroxide. 
 
7.2.3 Surgery Risks 
Recognized risks associated with lumbar fusion surgery and surgery in 
general, are well documented in literature and include but are not limited to: 
• 
Hardware related conditions such as malposition of the pedicle 
screws, pedicle wall perforation, hardware breakage/fracture or 
loosening, hardware disassembly, soft tissue irritation, and 
penetration of the endplate/disc, and other potential events related to 
the commercial hardware 
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• 
Incisional related including infection (local or deep tissue), 
Seroma/hematoma, hemorrhage, bone graft harvest site pain, and 
other potential incisional related events 
• 
Spine-related neurological conditions such as spinal cord 
compression, paraplegia, paraparesis, transient radiculopathy, reflex 
sympathetic dystrophy, dural teal, nerve injury, foot drop, and other 
potential neurological conditions 
• 
Spine-related musculoskeletal conditions such as sacroiliac joint 
instability or pain, symptomatic disc degeneration at other lumbar 
levels, muscle spasm or strain, vertebral body or facet fracture, bone 
infection, or other musculoskeletal conditions 
• 
General surgery related conditions including but not limited to events 
related to the respiratory (e.g., pneumonia, pulmonary embolism, 
pulmonary edema, atelectasis, anesthesia complications, etc.), 
cardiovascular (e.g., cardiac arrhythmia, myocardial infarction, 
stroke, coagulopathy, deep vein thrombosis, thrombophlebitis, 
transient drop in blood pressure, vascular injury, false aneurysm, 
etc.), endocrine/immune (e.g., adrenal insufficiency, adrenal 
hormone excess, diabetes mellitus, hypoglycemia, thyroid disorders, 
osteoporosis, pituitary disorder, amenorrhea, Graves’ disease, 
multiple sclerosis, myasthenia gravis, rheumatoid arthritis, lupus, 
etc.), gastrointestinal, urinary and reproductive symptoms (e.g., ileus, 
bowel incontinence, urinary tract infection, sexual dysfunction, etc.) 
• 
New, or increase in, pain experienced such as in the low back, 
leg(s), graft harvest site or other type of pain. 
• 
Exposure to radiation from medical imaging including x-rays to 
diagnose the condition and monitor recovery, and fluoroscopic 
imaging used during any treatment procedure; because ionizing 
radiation can cause damage to DNA, exposure can increase a 
person’s lifetime risk of developing cancer 
• 
Death 
 
 
7.3 
RISK MINIMIZATION 
 
In this investigation, risks will be minimized through the following measures: 
• 
Formal surgeon training in the proper use of the Spineology Interbody Fusion 
System, 
• 
Investigation site training on the study protocol and trial conduct,  
• 
Close subject assessment during the treatment and clinical follow-up period, 
and 
• 
Risk assessment based monitoring practices and trial oversight. 
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8.0 
SAFETY EVALUATION 
 
Safety of the Spineology Interbody Fusion System will be determined through the reporting 
process for Adverse Events.  All adverse events, whether felt to be device-related or not, 
are to be reported and followed at each study interval to resolution, or for events that 
remain unresolved, until the subject concludes study participation.  Information captured 
will include the type and description of the event, date of onset, treatment required and 
resolution status.  The investigator shall additionally provide any supplemental information 
pertinent to the overall evaluation of the event.  All reported events will be reviewed and 
adjudicated by an independent Data Monitoring Committee (DMC)/Clinical Events 
Committee (CEC). 
 
For this investigation, an adverse event is defined as a secondary disease or condition that 
develops in addition to, or at an increased rate or severity from, the expected response to 
treatment, necessitating further evaluation and treatment by a physician.  An adverse event 
may be an undesirable clinical occurrence, subject complaint, change in health status, or 
product issue.  A clinical event will not be reported if it existed at the time of enrollment and 
continued unchanged thereafter, unless the event worsened considerably requiring 
additional medical or pharmacological treatment.  Adverse Event reporting begins during 
the study treatment surgical procedure. 
 
8.1 
Adjudication Procedure 
 
Each AE will be reviewed individually by a DMC/CEC.  The DMC Charter is 
provided as Appendix V.  Each event is initially classified as an adverse event or a 
non-event.  A non-event is an event that does not require treatment.   An event 
captured and determined to be a non-event will be reported as an observation.  
Following this determination, an adverse event is assessed for relatedness to the 
trial and may be classified as a study-related adverse event or a not-study-related 
adverse event.  A not-study-related adverse event is an adverse event determined 
to not have a causal relationship with either the device or the procedure.  All study-
related adverse events are further adjudicated for severity and relatedness to the 
procedure/device as defined below. 
 
Event severity refers to the degree of seriousness of the AE.  The categories of 
event severity are: Serious Adverse Event (SAE) and a rating of mild, moderate or 
severe.  Event relatedness refers to the association to the investigational device, 
fixation hardware or the surgical procedure.  Event relatedness is categorized by 
the following associations:  device related, hardware related, procedure related, 
other related, or unknown (undeterminable) relatedness.  
 
For clarification, the following “relatedness” definitions will be applied in this 
investigation: 
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• 
Device Related:  An adverse event that results from the presence or 
performance of the SIFS mesh device. 
• 
Hardware Related:  An adverse event that results from the presence or 
performance of any of the supplemental fixation device components. 
• 
Procedure Related:  A procedure related adverse event shall be evaluated 
and adjudicated in accordance with the below sub-classifications.  A 
procedure related AE may occur as a result of one or more of the following 
and shall  be specified as such for analysis and reporting purposes:  
- 
Procedure – Device:  Occurs due to the implantation procedure for 
the investigational mesh device 
- 
Procedure – Hardware:  Occurs due to the implantation procedure 
for the supplemental fixation 
- 
Procedure – General Surgery:  Occurs as a result of the general 
surgical procedure and is not related to any of the above defined 
definitions or any of the below definitions. 
• 
Other Related:  An adverse event that occurs and is determined to have a 
relatedness that is not device, hardware, procedure, general surgery, or 
unknown relatedness. 
• 
Unknown:  An adverse event that cannot be determined to have a causal 
relationship with either the device or procedure will be classified as 
unknown. 
 
It is anticipated that resultant of the defined criteria for each relatedness 
determination, few adverse events will be categorized as “Other”.  The severity of 
events will be classified by the DMC as described in the following two sections. 
 
8.2 
Serious Adverse Event 
The DMC will first determine whether an AE is serious. A Serious Adverse Event, 
corresponding to FDA’s definition, is an adverse event that results in one of the 
following outcomes:  
• 
requires hospitalization, 
• 
prolongs hospitalization, 
• 
is life-threatening, 
• 
results in a congenital anomaly/birth defect, or 
• 
results in death. 
 
8.3 
Event Severity 
The DMC will adjudicate the severity of each AE. Severity is categorized as follows: 
• 
Severe Adverse Event: Significant impairment of functioning; subject is 
unable to carry out usual activities.  A severe AE requires treatment or 
intervention. 
• 
Moderate Adverse Event: Subject experiences sufficient discomfort to 
interfere with or reduce their usual level of activity.  A moderate AE 
requires treatment. 
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• 
Mild Adverse Event: Subject is aware of event or symptom, but 
event/symptom is easily tolerated.  A mild AE may not require treatment. 
 
The Clinical Event Committee shall be convened on a quarterly basis through the 
duration of the investigation to formally review and adjudicate study events.  The 
DMC Chairperson shall perform an interim (continuous) review of adverse events 
prior to conducting the quarterly committee review(s).  The Chairperson may 
convene a Committee meeting at his/her discretion at any time to ensure subject 
safety is adequately protected. 
 
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9.0 
ETHICS 
This investigation will be conducted in accordance with ethical principles having their 
origins in the Declaration of Helsinki.  This investigation will further be conducted in 
accordance with applicable federal regulations, specifically, the Title 21 Code of Federal 
Regulations, Part 812 – IDE Regulations, Part 50 – Informed Consent, Part 54 – Financial 
Disclosure, Part 56 – IRBs, ISO 14155 (2012), and ICH E6 – Good Clinical Practices 
(GCPs) Consolidated Guidance. 
 
9.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
 
Prior to participating in this investigation, the clinical site will be responsible for 
obtaining approval from their governing IRB.  The Principal Investigator (PI) at the 
site is responsible for obtaining and maintaining IRB approval to participate in this 
investigation.  A copy of the initial and all periodic review and approvals shall be 
maintained in the investigative site’s administrative binder.  A copy of each approval 
shall be provided to Spineology as the study sponsor and shall be maintained in the 
respective site administrative files. 
 
9.2 
INFORMED CONSENT 
 
Prior to enrolling subjects into this investigation, a site-specific IRB approved 
Informed Consent Form (ICF) is required.  The PI at each site is responsible for 
obtaining and maintaining the site-specific approved ICF.  A copy of the site-specific 
initial ICF, and any subsequent approved revisions of the ICF, will be provided to 
Spineology in a timely manner for maintenance in the respective site-specific 
administrative file. 
 
Subject participation in this investigation is voluntary.  In accordance with FDA 
regulation 21 CFR, Part 50, written informed consent is required of all subjects (or 
their legal representative) prior to study participation.  Spineology is required to 
report any failure to obtain subject consent to FDA within 5 working days of 
learning of such an event (21 CFR, §812.150(b)(8)). 
 
A sample Informed Consent Form Template for this investigation is provided as 
Appendix VI. 
 
9.3 
PATIENT DATA CONFIDENTIALITY 
 
All information and data provided to Spineology concerning subjects and their 
participation in this clinical investigation will be considered confidential by 
Spineology.  Only authorized sponsor personnel or an appropriately identified FDA 
representative will have access to these confidential files.  All data used in the 
analysis and reporting of this investigation will be without identifiable reference to 
specific subject names.  Subjects will be identified by a three (3) digit (sequential) 
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number and a three (3) letter name code.  The name code will be determined using 
the subject’s first-middle-last initials.  As an example, a subject named John Quincy 
Smith would have a name code of JQS.  In the event a subject does not have a 
middle name, a dash (-) shall be used in its place.  Further, each investigative site is 
assigned a three (3) digit number as the site identifier code by the sponsor.  The 
site ID together with the subject ID and name code shall constitute the complete 
subject ID.  As an example, if John Quincy Smith was the first subject enrolled at a 
site assigned a site ID code of 123, he would be identified as subject 123-001 JQS.  
All subject IDs are unique to the site/subject.   
 
Data collected in this investigation will be obtained in compliance with applicable 
federal regulations relating to confidentiality and security of protected health 
information (PHI) including by not limited to the Health Insurance Portability and 
Accountability Act (HIPAA).  HIPAA regulations require a signed subject 
authorization, which informs the subject of the following:  
• 
What PHI will be collected from trial subjects, 
• 
Who will have access to that information and why, and  
• 
Who will use or disclose that information. 
In the event that a subject revokes authorization to collect or use PHI, the 
Investigator, by regulation, retains the ability to use all information collected prior to 
the revocation of subject authorization.  For subjects who have revoked 
authorization to collect or use PHI, attempts should be made to obtain permission to 
collect at least vital status (i.e., that the subject is alive) at the end of their scheduled 
trial period. 
 
In accordance with HIPAA regulations, subject records leaving the facility for 
purposes of the investigation should be identified by the Subject ID assigned for the 
trial and should not include the subject’s name, whenever practical.  Every effort 
should be made to “black out” (redact) the subject’s name from medical records, 
including x-rays, prior to sending to Spineology. 
 
This trial is being conducted in compliance with FDA 21 CFR and all personal 
information pertaining to subjects will be kept confidential.  Whenever practical, 
subjects will be identified only by their subject ID number and initials.  Clinical trial 
documents and hospital and clinic medical records pertaining to trial subjects may 
be reviewed by Spineology trial personnel or their representatives, FDA, or other 
health inspectors as needed to assure compliance with trial requirements. 
 
Information obtained in the course of executing this trial, including still and motion 
photography, may be presented for regulatory, clinical or educational purposes 
provided no subject is identified.  The information collected is the property of 
Spineology. 
 
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9.4 
DATA MONITORING COMMITTEE (DMC) 
 
An independent Data Monitoring Committee will be established for this investigation 
and will function as an advisory group to provide independent oversight of the 
investigation and to ensure patient safety.  The DMC shall be comprised of no less 
than three (3) physician consultants of appropriate training, expertise and 
experience in the spinal discipline and a biostatistician.   A DMC Chairperson shall 
be designated to preside over DMC meetings.  The DMC may function in the role of 
a Data Safety Monitoring Board (DSMB) and as a Clinical Events Committee (CEC). 
The complete DMC Charter is provided as Appendix V. 
 
DMC DSMB primary responsibility is to ensure subject safety.  Additional DMC 
DSMB responsibilities may include, but are not limited to, review of interim analyses 
of outcomes, safety data summaries and study performance information.  In 
addition, the DMC DSMB may provide recommendations relative to the study 
design, stopping rules for trial conduct, and determinations for continuance, 
modification, or termination of investigation conduct.  DMC DSMB meetings will be 
conducted no less than annually. 
 
DMC CEC responsibilities include review and adjudication of all adverse events 
reported for this investigation.  The DMC CEC shall adjudicate events for 
seriousness, relatedness and severity.  The DMC CEC shall review all events for 
potential UADE occurrence.  DMC CEC meetings shall be conducted on a quarterly 
basis throughout the duration of this investigation.  
 
9.5 
FINANCIAL DISCLOSURE 
 
All clinical investigators shall disclose to the sponsor sufficient and accurate 
financial information enabling Spineology to submit complete and accurate 
certification or disclosure statements as appropriate.  The investigator shall 
promptly update this information should any relevant changes occur during the 
course of the investigation and for one (1) year following completion of this 
investigation.  
 
9.6 
RADIOGRAPHIC CORE LAB 
 
An independent core lab will be established to perform the required qualitative and 
quantitative x-ray measurements/assessments.  In addition, two (2) core lab 
radiologists will perform fusion assessments at the 12-month and 24-month time 
points.  A third core lab radiologist will function in the role of adjudicator in the event 
of discrepant readings between Reviewer 1 and Reviewer 2.  For greater detail on 
core lab responsibilities and assessment, refer to the Radiographic and Core Lab 
Assessment Protocol provided as Appendix IV.    
 
 
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9.7 
INVESTIGATIONAL DEVICE USE AND DISPOSITION 
 
As previously stated within this investigation protocol, only sites approved by 
Spineology Clinical Affairs shall receive investigational product.   
 
For this investigation, SIFS product shall be provided to sites on a ship-in/ship-out 
basis in support of study cases.  Accordingly investigational product shall not be 
stored or maintained at the investigation site.  Following case conclusion, the study 
product shall be returned to sponsor.  Inventory accountability will be managed and 
tracked by sponsor and reported to FDA as a component of the annual reporting 
requirements.  Records pertaining to device shipment shall be maintained by 
sponsor with copies of device receipt invoices shipped to the site maintained in the 
respective site’s administrative files.  Device shipping invoices shall include the 
name of the consignee, type and quantity of device, date of shipment, and the lot 
number. 
 
The site primary investigator is responsible for ensuring that investigational devices 
are made available only to site personnel who are authorized to access them and 
only to subjects under the Investigator’s or sub-Investigator’s supervision. 
 
At the completion of the clinical investigation, any investigational product present at 
the site must be returned to Spineology.  Further, a complete, and final, device 
accountability and reconciliation will be performed by Spineology at investigation 
conclusion and reported to FDA in accordance with Federal regulation. 
 
 
 
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10.0 DATA COLLECTION FORMS 
The following patient-centric forms shall be used to record data in this investigation.  Case 
report forms (CRFs) shall be completed accurately and in a timely manner.  The Principal 
Investigator at each study site is responsible for oversight of the completion and 
submission of all clinical data collect at the respective site.  For this investigation, data will 
be collected electronically and in compliance with the Code of Federal Regulations Title 21 
Part 11.   
 
The electronic version of the CRF is referred to as the eCRF.  The eCRFs displayed in the 
electronic data capture (EDC) system implemented for this investigation yields additional 
functionality and form prompting beyond the basic information identified for capture in the 
paper version of the CRF.  The eCRF is completed by the site in the EDC system.  The 
paper version of the forms is provided to investigative sites in the form of worksheets for 
ease of use.  The Inclusion/Exclusion worksheet and the Patient Survey worksheet may 
function as source documentation and shall be treated accordingly.  The site shall provide 
the sponsor with redacted copies of all supporting source documentation as required to 
support centralized monitoring capabilities.  Sample CRFs are provided as Appendix VII. 
 
Screening Log – This log will record each subject enrolled into the investigation.  It will 
additionally include patients screened for potential inclusion that fail to meet study entrance 
criteria.  For screen failures, minimal information is collected to ensure compliance with 
HIPAA guidelines and to protect patient confidentiality.  The eScreening Log should be 
updated on a regular basis by the site. 
 
Inclusion/Exclusion Entrance Checklist – This form will be used to screen subjects for 
study entrance criteria to confirm the individual is an appropriate candidate for study 
participation. The eCRF should be entered in the EDC system as soon as reasonable but 
no later than 10 working days of subject enrollment.   
 
Baseline/Pre-op History Form – This form captures relevant baseline information such as 
demographics, diagnosis for procedure, spinal treatment (conservative measures and 
surgical intervention) history, work status, etc.  The eCRF should be entered in the EDC 
system within 10 working days of subject enrollment. 
 
Patient Survey – This survey form collects subjective data consisting of pain rating on a 
Visual Analog Scale (VAS) for the low back, right leg, left leg and iliac crest as applicable 
(iliac crest completed at post-op intervals only for subject who underwent iliac crest graft 
harvest).  The survey additionally contains a 10-question Oswestry Disability Index (ODI) to 
assess low back function and an SF-36 health questionnaire to assess mental and physical 
components.  Lastly, this form allows the subject to rate their level of satisfaction with their 
surgical outcome and is to be completed only at the post-op follow-up intervals.  The eCRF 
should be entered in the EDC system within 10 working days of the study visit date. 
 
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Pain Medication Log – The pain medication log shall be completed at baseline and 
reviewed at each subsequent study interval follow-up examination.  The log shall be 
updated for changes in pain medication use (start, stop, changes in dosing) as compared to 
the previous study interval visit.  Beyond identifying the prescription information (i.e. 
medication name, strength and frequency of use), the site shall specify if the pain 
medication is prescribed for treatment of low back pain or for other reasons. The eLog 
should be reviewed/updated in the EDC system within 10 working days of the study visit 
date. 
 
Neurological Evaluation – This form captures relevant neurological testing for the lumbar 
spine (L2 – S1).  Neurological testing includes assessment of bilateral lower extremity deep 
tendon reflexes (knee and ankle), muscle strength tested against resistance (hips, knees, 
ankles, and feet), and lumbosacral dermatome sensation (low back, thighs, calves, and 
feet).  The eCRF should be entered in the EDC system within 10 working days of the study 
visit. 
 
Surgery/Hospitalization – This form records relevant information regarding the study 
procedure including hospitalization duration, device detail, supplemental fixation detail and 
operative/intraoperative/postoperative findings. The eCRF should be entered in the EDC 
system within 10 working days of the subject discharge date. 
 
Follow-Up Evaluation – This form captures relevant information regarding postoperative 
subject medical care, tobacco use, alcohol consumption, work status and occurrence of 
adverse events.  The eCRF should be entered in the EDC system within 10 working days 
of the study visit. 
 
Long-Term Follow-Up Questionnaire – This self-administered patient questionnaire 
captures relevant information regarding postoperative subject tobacco use, alcohol 
consumption, work status and safety information (occurrence of additional surgical 
intervention).  In the event a subject identifies supplemental surgical intervention has 
occurred, the study site shall complete a corresponding adverse event form after obtaining 
the necessary and appropriate information.  The questionnaire eCRF should be entered in 
the EDC system within 10 working days of completed form receipt. 
 
Adverse Event (AE) – This form shall be entered into the EDC system as soon as 
reasonable for any subject presenting with an adverse event.  Beyond eCRF completion, 
the site shall forward copies of redacted source documentation that support the AE to the 
sponsor.  As noted above, the eCRF shall be entered in the EDC system as soon as 
reasonable but not greater than 15 working days of discovery of the event.  The source 
documentation copies shall ideally be forwarded to Spineology within 15 working days of 
the discovery of the event. 
 
Protocol Deviation (PD) – This form documents deviations from the study protocol.  
Protocol deviations shall be entered into the EDC system within 5 working days of the 
discovery of the deviation.  
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Subject Discontinuation (SD) – This form documents a subject’s decision to withdraw 
from the investigation or an investigator’s determination to discontinue a subject from study 
participation.  The SD form shall be entered into the EDC system within 15 working days of 
the discontinuation notification. 
 
Unanticipated Adverse Device Effect (UADE) – The UADE form records any unexpected 
adverse device effects experienced by a study subject.  The investigator is required to 
notify the sponsor as soon as possible but not later than 10 working days after discovery of 
the UADE.  The UADE form is entered into the EDC system by the site. 
 
 
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11.0 DEFINITIONS 
Adverse Event – A secondary disease or condition that develops in addition to, or at an increased 
rate or severity from, the expected response to treatment, necessitating further evaluation and 
treatment by a physician.  All adverse events, whether related or unrelated to the device or 
procedure, shall be captured and reported. Further, all adverse events will be adjudicated by the 
Data Monitoring Committee and reported to FDA per protocol. 
Case Report Form (CRF)/Electronic Case Report Form (eCRF)/CRF Worksheet –  
• 
CRF – A document designated to record protocol required information for each subject 
participating in an investigation.  A CRF may be provided to sites in paper copy or 
electronic copy.  A paper CRF may be used as a worksheet providing the captured 
information is recorded in the electronic database. 
• 
eCRF – A database equivalent electronic version of the CRF. 
• 
CRF Worksheet – A paper version of a CRF used to collect data that will be entered into 
the eCRF.  Worksheets shall be maintained in the relevant study subject’s binder at the 
investigation site. 
Centralized Monitoring – A remote evaluation carried out by sponsor personnel or 
representatives (e.g., clinical monitors, data management personnel, or statistician) at a location 
other than the site(s) at which the clinical investigation is being conducted. 
Device Related – An adverse event that results from the presence, performance or implantation 
procedure of the investigational device (SIFS mesh). 
Enrolled – For this investigation, a subject is considered enrolled after meeting all study entrance 
criteria, has confirmed agreement to participate in the investigation as documented through 
completion of the informed consent process, and has been assigned a surgical procedure date.  
Further, it is expected that prior to enrollment, the investigational site will have successfully 
negotiated the precertification process as required for pertinent insurance carriers, and obtained 
documentation of the carrier’s precertification approval.   
Extended Hospitalization – Increased duration of hospitalization based on determination of the 
treating investigator. 
Functional Disability – In this investigation, functional disability is defined as the subject’s self-
rated score on the Oswestry Disability Index.  The ODI is a commonly used 10 question instrument 
for assessing patients with back pain.  The greater the score achieved, the greater the functional 
disability.  A lower ODI score indicates less back disability (greater back function).  A 15 point 
difference compared to baseline is considered clinically significant. 
Hardware Related AE – An adverse event that results from the presence, performance or 
implantation of the supplemental fixation device hardware or its components. 
Informed Consent – A process by which a subject voluntarily confirms his or her willingness to 
participate in a particular investigation, after having been informed of all aspects of the 
investigation that are relevant to the subject’s decision to participate.  Informed consent is 
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documented by means of a written, signed, and dated informed consent form approved by the 
site’s reviewing IRB. 
Institutional Review Board (IRB) – An independent body (a review board or a committee, 
institutional, regional, or national (centralized) constituted of medical/scientific professionals and 
non-medical/non-scientific members, whose responsibility it is to ensure the protection of the 
rights, safety, and well-being of human subjects involved in an investigation and to provide public 
assurance of that protection, by among other things, reviewing and approving/providing favorable 
opinion on the investigation protocol, the suitability of the investigator(s), facilities, and the methods 
and materials s to be used in obtaining and documenting informed consent of the investigation 
subjects. 
Low Back Pain (LBP) – For this investigation, LBP is defined as the self-rated score a subject 
indicates on a Visual Analog Scale during normal daily activities.  When interpreting the VAS, a 
higher score indicates a greater level of pain severity and a lower score indicates a lesser severity 
of pain.  LBP is captured on a 100mm VAS.  A 20mm difference when compared to baseline is 
considered clinically significant.  The same measurement system/guideline is employed for leg 
pain. 
Not Study-Related AE – An event adjudicated by the DMC CEC and determined to not have a 
causal relationship with either the device or the procedure. 
Observation – An observation is an event adjudicated by the DMC CEC and determined to be a 
non-event and did not require treatment. 
On-Site Monitoring – An in-person evaluation of the clinical investigation site that is conducted by 
sponsor personnel or representatives. 
Other Related AE – An adverse event that occurs and is determined to have a relatedness that is 
not device, hardware general surgery or unknown relatedness. 
Procedure Related AE – An adverse event that occurs as a result of the surgical procedure.  A 
procedure related AE may occur as a result of one or more of the following and shall be specified 
as such for analysis and reporting purposes: 
• 
Procedure – Device:  Occurs due to the implantation procedure for the investigational 
device (SIFS mesh) 
• 
Procedure – Hardware:  Occurs due to the implantation procedure for the supplemental 
fixation 
• 
Procedure – General Surgery:  Occurs as a result of the general surgical procedure 
Removal – A surgical procedure in which all of the original system (intervertebral device plus 
supplemental fixation) confirmation is removed, with or without replacement. 
Re-Operation – Any surgical procedure at the treated level that does not include removal, 
modification, or addition of any implanted components. 
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Revision: Device – A surgical procedure that adjusts or in any way modifies or removes part of 
the original intervertebral implant configuration, with or without replacement of a component.  A 
revision may also include adjusting the position of the original configuration. 
Revision: Hardware – A surgical procedure that adjusts or in any way modifies or removes part of 
the original supplemental fixation implant configuration, with or without replacement of a 
component.  A revision may also include adjusting the position of the original configuration. 
Risk-Based Monitoring – A dynamic assessment procedure that systematically approaches 
clinical trial monitoring of the individual and global investigation sites, evaluating for data integrity, 
observable trending and compliance risks that may be associated with the clinical investigation 
during the trial lifecycle. 
Serious Adverse Event (SAE) – An adverse event that requires hospitalization, prolongs or 
extends the hospitalization, is life-threatening, results in a congenital anomaly/birth defect, or 
results in death.  The device-relatedness or procedure-relatedness of such an event will be 
adjudicated by the DMC. 
Study-Related Event – An event that meets the definition of an Adverse Event and in addition is 
determined to have a causal relationship to the study and/or attributable to study participation.  The 
application of a Study-Related Adverse Event status is determined by the Data Monitoring 
Committee (DMC) as a component of the adjudication process. While all events regardless of 
status, categorization or relatedness are adjudication by the DMC and reported to FDA, only those 
events determined to be Study-Related Adverse Events will be included in the final statistical 
analysis for this trial. 
Unknown Related AE – An adverse event that cannot be determined to have a causal 
relationship with either the investigational device, supplemental fixation hardware or its 
components, general surgery, or other relatedness. 
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or safety, 
any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem or death was not previously identified in nature, severity or degree of incidence in the 
application; or any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects. 
 
 
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12.0 PROTOCOL DEVIATION 
Deviations from protocol shall be document on a Protocol Deviation (PD) Form.  PDs are 
reportable to the investigator’s reviewing IRB and to FDA as a component of the periodic 
(annual) reporting requirements, unless otherwise directed by the reviewing IRB 
requirements or as the specific circumstance dictates. 
 
Every attempt shall be made to adhere to the investigation protocol.  Should an investigator 
deviate from the protocol to protect the life or physical wellbeing of a study subject in an 
emergent circumstance, such notice shall be given to the sponsor as soon as possible, but 
not more than five (5) working days from the date the emergency occurred.  With the 
exception of the emergent circumstance, prior approval from the study sponsor is required 
for any change in, or deviation from, the investigation protocol considered to be major as 
such changes may affect the scientific soundness of the clinical investigation or the rights, 
safety, and welfare of study subjects. 
 
For reporting purposes, deviations from protocol shall be grouped into the below 
categories.  Examples are provided to ensure consistent reporting. 
• 
Major Protocol Deviation – a deviation from the study protocol that impacts the 
risks and benefits of the study; impacts participant safety, affects the integrity of 
study data, or affects a participants willingness to participate in the study.  For 
example: 
o Failure to obtain informed consent 
o Informed consent obtained after the study procedure is performed 
o Use of an invalid Informed Consent Form, i.e., consent form without IRB 
approval stamp, or outdated/expired consent form 
o Enrolling subjects outside the study entrance criteria  
o Failure to perform the final (24-month) study examination/required 
testing as this impacts the study integrity  
• 
Minor Protocol Deviation – a deviation from the study protocol that does not 
impact participant’s safety, compromise the integrity of the study data, or affect 
participants’ willingness to participate in the study.  For example: 
o Study visit conducted outside the required timeframe 
o Failure to perform a required interval evaluation – excluding the final (24-
month) exam 
o Failure to perform a required research activity 
 
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13.0 COMPLIANCE 
It is expected that investigational sites (investigators, study coordinators, ancillary site 
personnel, and subjects) will be compliant with the investigation protocol.  Should it be 
determined that the site is noncompliant, reasonable efforts will be made to secure 
compliance.  These efforts/actions will be documented in writing and maintained within the 
sponsor study administration file.  Should it be determined significant site compliance or 
site management issues present, these will be documented in a clinical corrective and 
preventative action (cCAPA) plan.  The cCAPA shall define the infraction, outline an action 
plan to achieve resolution, and be signed by the sponsor representative and the principal 
investigator at the site.  A copy of the signed cCAPA shall be maintained at the 
investigational site with the original being maintained by the sponsor in the site-specific 
administrative files.   
 
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14.0 INVESTIGATOR RESPONSIBILITY 
Investigators are responsible for ensuring the investigation is conducted in accordance with 
the study protocol and applicable federal regulations (21 CFR, Subpart E).  Investigators 
are additionally responsible for: 
• 
Obtaining IRB approval for study conduct and re-approval as applicable.  If more 
than one (1) investigator at a site is participating in the investigation, the Principal 
Investigator (PI) shall be responsible for obtaining initial IRB approval and 
subsequent IRB approvals for the duration of time the site is participating in the trial. 
• 
Obtaining informed consent of study subjects prior to enrollment into the 
investigation 
• 
Protecting the subject’s rights, safety and welfare 
• 
Maintenance of subject records and confidentiality 
• 
Record retention as defined per federal regulations 21 CFR, §812.140 (a), (d), and 
(e) 
• 
Management of investigation and study related activities in accordance with the 
Clinical Trial Agreement (CTA) 
• 
Submission of site-specific study closure report to the reviewing IRB within three (3) 
months of notification from the sponsor.  If more than one (1) investigator is 
participating in the trial at a given site, the PI is responsible for submission of the 
closure report to the reviewing IRB. 
• 
Return of any unused investigational product to the study sponsor upon request by 
Spineology or at the conclusion of the investigation. 
 
Note:  In the event that an Investigator withdraws from the responsibility to maintain records 
for the required period of retention required for this investigation, a transfer of custody of 
records shall be permitted.  The transfer of custody must be to an individual willing to 
accept responsibility for the records in accordance with Federal regulation.  Further, a 
notice of transfer of records shall be provided to FDA no later than 10 working days after 
the transfer occurs. 
 
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15.0 SPONSOR RESPONSIBILITY 
The study sponsor, Spineology, is responsible for ensuring the investigation is conducted in 
accordance with the study protocol and applicable federal regulations, specifically, Title 21 
Code of Federal Regulations, Part 812, Part 50, Part 54, Part 56 and Good Clinical 
Practices (GCPs). 
 
Although included in the above citation, Spineology is additionally responsible for the 
following: 
• 
Selecting qualified investigators and providing study investigators with 
appropriate information for study conduct (21 CFR 812.40) 
• 
Ensuing review and approval process for reviewing IRB(s) is obtained (21 CFR 
812.40) 
• 
Appropriate monitoring of the clinical investigation (21 CFR 812.46) 
• 
Appropriating reporting in accordance with federal regulation (21 CFR, 
812.150(b)(1-10) 
• 
Record maintenance and retention per federal regulation (21 CFR, 812.140 
(b)(d) and (e)) 
• 
Prompt notification of FDA, IRBs, and al investigators of unanticipated adverse 
device effects (21 CFR 812.150(b)(1)) 
• 
Submission of progress reports in accordance with federal regulation (21 CFR 
812.150(b)(5) 
• 
Submission of final study closure report that details the cumulative study 
experience to FDA, governing IRBs, and Investigators within six (6) months of 
completing the clinical investigation, in addition to fulfilling semi-annual and 
annual reporting requirements (21 CFR 812.150(b)(7))  
 
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16.0 MONITORING PLAN 
This clinical investigation will be monitored by Spineology personnel, or a designated 
Spineology representative, for appropriate study conduct, compliance and date integrity.  In 
accordance with the Food and Drug Administration’s Guidance for Industry, Oversight of 
Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013) publication, 
risk-based monitoring practices shall be implemented for the present investigation.  
Monitoring efforts shall employ periodic on-site monitoring visits and centralized (remote) 
monitoring that align with Spineology Standard Operating Procedures for clinical site and 
investigation monitoring. 
 
On-site monitoring shall be conducted to identify data entry errors and discrepancies, 
missing data, missing data in source records/documents, provide assurance of appropriate 
source documentation existence, educate sponsor personnel on site-specific procedures, 
assess site compliance with protocol, and evaluate sites for maintenance or changes in 
staff, facility, and resources. 
 
Centralized monitoring shall be conducted for remote source data verification, site 
characteristics and performance metrics to assess for trends, detect high risk type errors 
and evaluate for other potential risk factors.  High risk indicators include, but are not limited 
to, elements of: 
• 
Protocol Integrity – randomization/blinding, study entrance criteria, protocol 
procedure deviation, and lost-to-follow-up. 
• 
Patient Safety – adverse events, serious adverse events, unanticipated adverse 
device effects, inclusion deviations, and informed consent deviation. 
• 
Regulatory Compliance – Institutional Review Board approval and 
investigational device handling/management. 
• 
Data Quality – Query resolution, missing data, and missed visit deviations. 
 
For data evaluation, should discrepancies be identified between the comparison of source 
data and submitted data, data queries will be assigned by the monitor and resolved by the 
investigational site.  Following conclusion of the investigation, Spineology monitors will 
conduct a site specific study closure visit.  The study closure visit will consist of 
reconciliation of data inconsistencies, outstanding data queries, review of previously 
unresolved adverse event to either obtain resolution or a current status determination if 
unable to resolve, and review of administrative materials.  In addition, Spineology will 
perform a device reconciliation of all investigational product ensuring that any and all 
investigational product that may be at an investigational site is returned to the sponsor.  
Study closure visits will occur within three (3) months following study conclusion. 
 
 
 
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Monitoring of this clinical investigation will be accomplished by Spineology, Inc., and 
performed under the supervision of: 
 
 
 
Spineology, Inc. 
7800 3rd Street North, Suite 600 
Saint Paul, MN 55128-5455 
 
 
 
 
 
 
 
 
Record retention for this investigation shall be in accordance with Federal regulation (21 
CFR §812.140 (a) (b).  Accordingly, Investigator and sponsor investigation records shall be 
maintained for a period of two (2) years or after the latter of the following two (2) dates: 
• 
The date on which the investigation is terminated or completed, or 
• 
The date that the records are no longer required for purposes of supporting the 
sponsor’s premarket approval application or a notice of completion of a product 
development protocol. 
 
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17.0 REFERENCES 
1. Fritzell P, Hagg O, Wessberg P, et al. Chronic low back pain and fusion: A comparison of three 
surgical techniques. A prospective multicenter randomized study from the Swedish lumbar 
spine group. Spine 2002;27:1131-1141. 
2. Crock HV. Internal disc disruptions: A challenge to the disc prolapse 50 years on. Spine 
1996;11:650-653. 
3. 3.Friberg S, Hirsch C. Anatomical and clinical studies on lumbar disc degeneration. 1950 
[classical article] Clin Orthop 1992;279:3-7. 
4. Hacker RJ. Comparison of interbody fusion approaches for disabling low back pain. Spine 
1997;22:660-666. 
5. Cavanaugh JM. Neural mechanisms of lumbar pain. Spine 1995;20:1804-1809. 
6. Crock HV. A reappraisal of intervertebral disc lesions. Med J Aust 1970;1:983-989. 
7. Schwarzer AC, Aprill CN, Derby R, et al. The prevalence and clinical features of internal disc 
disruption in patients with chronic low back pain. Spine 1995;20:1878-1883. 
8. Lowe TG, Tahernia AD, O’Brien MF, et al. Unilateral transforaminal posterior lumbar interbody 
fusion (TLIF): indications, technique, and 2-year results. J Spinal Disord 2002;15:31-38. 
9. Boucher HH. A method of spinal fusion. JBJS [Br] 1959;41:248-259. 
10. Stauffer RN, Coventry MB. Posterolateral lumbar spine fusion. JBJS 1972;54:1195-1204. 
11. Thompsom WAL, Ralston EL. Pseudoarthrosis following spine fusion. JBJS 1949;31:400-405. 
12. Watkins MB. Posterior lateral fusion in pseudoarthrosis and posterior elements defects of the 
lumbar spine. Clin Orthop 1964;35:80-85. 
13. Herkowitz HN, Didhu KS. Lumbar spine fusion in the treatment of degenerative conditions. 
Current indications and recommendations. J Am Acad Orthop Surg 1995;3:123-135. 
14. Yashiro K, Homma T, Hokari Y, et al. The Steffe variable screw placement system using 
different methods of bone grafting. Spine 1991;16:1329-1934. 
15. Mura PP, Costaglioli M, Piredda M, Caboni S and Casula S: TLIF for symptomatic disc 
degeneration: a retrospective study of 100 patients. European Spine Journal 20 (Suppl 1): 57 – 
60, May 2011. 
16. Dhall SS, Wang MY and Mummaneni PV: Clinical and radiographic comparison of mini-open 
transforaminal lumbar interbody fusion with open transforaminal lumbar interbody fusion in 42 
patients with long-term follow-up. Journal of Neurosurgery Spine 9:560-565, 2008. 
17. Schwender JD, Holly LT, Rouben DP and Foley KT: Minimally Invasive Transforaminal Lumbar 
Interbody Fusion (TLIF): Technical Feasibility and Initial Results. Journal of Spinal Disorders 
and Techniques 18 (Suppl 1): S1 – S6, February 2005. 
18. Villavicencio AT, Burneikiene S, Roeca CM, Nelson EL and Mason A: Minimally invasive 
versus open transforaminal lumbar interbody fusion. Surgical Neurology International 1 (12), 
2010. 
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19. Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery of lumbar disc prolapse and 
degeneration lumbar spondylosis. Spine 1999;24:1820-1832. 
20. Mardjetko SM, Connolly PJ, Shott S. Degenerative lumbar spondylosis: A meta-analysis of 
literature. 1970-1993. Spine 1994;20(Suppl):S2256-2265. 
21. Tsantrizos A, Baramki HG, Zeidman S, et al. Segmental stability and compressive strength of 
posterior lumbar interbody fusion implants. Spine 2000;25:1899-1907. 
22. Enker P, Steffe AD. Interbody fusion and instrumentation. Clin Orthop 1994;300:90-101. 
23. Evans JH. Biomechanics of lumbar fusion. Clin Orthop 1985;193:38-46. 
24. Linson MA, Williams H. Anterior and combined anterior-posterior fusion for lumbar disc pain: A 
preliminary study. Spine 1991;16:143-145. 
25. Newman MH, Grinstead GL. Anterior lumbar interbody fusion for internal disc disruption. Spine 
1992;17:831-833. 
26. Shekelle PG, Markovich M, Louie R. An epidemiologic study of episodes of back pain care. 
Spine 1995;20:1668-1673. 
27. Hashimoto T, Shigenobu K, Kanayama M, et al. Clinical results of single-level posterior lumbar 
interbody fusion using the Brantigan I/F carbon cage filled with a mixture of local morselized 
boine an dbioactive ceramic granules. Spine 2002;27:259-262. 
28. Cloward RB. The treatment of ruptured intervertebral discs by vertebral body fusion: Report of 
750 cases. J Neurosurg 1953;10:154-167. 
29. Lin P, Cautilli R, Joyce M. Posterior lumbar interbody fusion. Clin Orthop 1983;180:154-167. 
30. Zdeblick TA, Ulschmid S, Dick JC. The surgical treatment of L5-S1 degenerative disc disease: 
A prospective randomized study of laproscopic fusion. Orthop Trans 1996;7:20:75. 
31. Flynn JC, Price CT. Sexual complications of anterior fusion of the lumbar spine. Spine 
1984;9:489-492. 
32. Watkins R. Anterior lumbar interbody fusion surgical complications. Clin Orthop 1992;284:41-
53. 
33. Baker JK, Reardon PR, Reardon MJ, et al. Vascular injury in anterior lumbar surgery. Spine 
1993;18:2227-2230. 
34. Johnson RM, McGuire EJ. Urogenital complications of anterior approaches to the lumbar 
spine. Clin Orthop 1981;154:114-118. 
35. Deyo R, Gray D, Kreuter W, Mirza S, Martin B. United States Trends in Lumbar Fusion Surgery 
for Degenerative Conditions. Spine 2005;30:1441-1445. 
36. Williams A, Gornet M, Kurkus J. CT Evaluation of Lumbar Interbody Fusion: Current Concepts. 
Am J Neuroradiol 2005;26:2057-2066. 
 
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18.0 STUDY SPONSOR 
Comments or correspondence pertinent to this study should be directed to: 
 
 
Spineology, Inc. 
7800 3rd Street North 
Suite 600 
Saint Paul, MN 55128-5455 
 
 
 
 
 
 
Or 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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19.0 REVISION HISTORY 
Revision 
Effective  
Date 
DCO Ref. # 
Reason/Description of Change 
A 
03Sep2014 
4618 
Origination 
 
 
 
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