Retrospective Evaluation of the Clinical and Radiographic Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion.
Conditions: Spinal Stenosis
Sponsor: Paradigm Spine

Page 1 of 14 
Version 5.0, 22NOV2016 
 
 
 
 
 
 
Retrospective Evaluation of the Clinical and Radiographic 
Performance of coflex® Interlaminer Technology Versus 
Decompression With or Without Fusion. 
 
Study ID Number: CRDC2016 
 
Version 5.0 
 
02November2016 
 
Study Phase: Post-Market 
 
 
 
Paradigm Spine 
 
505 Park Avenue, 14th Floor 
 
New York, NY 10022 
 
 
 
 
Change History 
Version 
Version Date 
Summary of Changes 
1.0 
 
14June2016 
Original 
2.0 
 
 
28June2016 
Data collection to include 1 or 2 level decompression with 
or without fusion. 
3.0 
 
11July2016 
Protocol title to reflect evaluation of coflex versus efficacy. 
4.0 
 
19August2016 
Study Start Date and End Date applicable for Baptist IRB 
5.0 
 
 
22Novmeber2016 
Data collection to include 5000 patients from 50 sites.  Primary 
and Secondary Endpoints. 
 
 
 
 
 
 

Page 2 of 14 
Version 5.0, 22NOV2016 
 
 
 
Table of Contents 
Retrospective Evaluation of the Clinical and Radiographic Performance of coflex® 
Interlaminer Technology Versus Decompression With or Without Fusion............... 1 
Table of Contents.......................................................................................................... 2 
Investigator Signature Page ......................................................................................... 3 
Protocol Summary ........................................................................................................ 4 
Retrospective Evaluation of the Clinical and Radiographic Performance of coflex® 
Interlaminer Technology Versus Decompression With or Without Fusion............... 4 
Study Abbreviations ..................................................................................................... 5 
1.0 Introduction .......................................................................................................... 6 
2.0 Study Purpose ...................................................................................................... 6 
2.1 
Primary Objective .......................................................................................... 6 
2.2 
Secondary Objectives .................................................................................... 6 
3.0 Eligibility Criteria.................................................................................................. 7 
3.1 
Inclusion criteria............................................................................................. 7 
3.2 
Exclusion criteria ........................................................................................... 7 
4.0 Study Design ........................................................................................................ 7 
4.1 
Endpoints ...................................................................................................... 7 
4.2 
Data Collection Summary .............................................................................. 8 
4.3 
Informed Consent .......................................................................................... 9 
4.4 
Data Collection Procedures ........................................................................... 9 
 
4.4.1 Baseline Visit ............................................................................................. 9 
 
4.4.2 Surgical Treatment Visit ........................................................................... 10 
 
4.4.3 Post-Operative Hospital Stay ................................................................... 11 
 
4.4.4 Follow-Up Visits ....................................................................................... 11 
5.0 Statistical Analysis............................................................................................. 11 
5.1 
General Information ..................................................................................... 11 
5.2 
Primary Endpoint ......................................................................................... 12 
5.3 
Secondary Endpoints................................................................................... 12 
6.0 Study Management ............................................................................................ 12 
6.1 
Ethics........................................................................................................... 12 
6.2 
Data Entry ................................................................................................... 12 

Page 3 of 14 
Version 5.0, 22NOV2016 
 
 
 
 
 
Investigator Signature Page 
 
My signature below attests that I have read the contents of this protocol and agree to conduct 
the study according to the protocol and that the study will not be initiated without the approval 
of the appropriate Institutional Review Board or Independent Ethics Committee. 
 
 
 
 
Investigator: 
 
 
Print Name: 
Signature: 
Date: 

Page 4 of 14 
Version 5.0, 22NOV2016 
 
 
 
Protocol Summary 
 
Study Title 
Retrospective Evaluation of the Clinical and Radiographic Performance of 
coflex® Interlaminar Technology Versus Decompression With or Without 
Fusion. 
Purpose 
To evaluate clinical, radiologic and patient-reported outcomes who have 
been treated 1 or 2 levels with the coflex® Interlaminar Technology or 
decompression with or without fusion. 
Study Design 
Retrospective, multi-center, post-market clinical study 
Devices 
coflex® Interlaminar Technology 
Data Collection 
Clinical, radiologic and patient reported outcomes data will be collected for 
approximately 5000 patients from 50 sites 
Study Duration 
Up to 6 months for data collection 
Start Date: June 2013 
End Date: April 2017 
Study Objectives 
Primary Objective: 
 
To assess the operative details and safety outcomes associated 
with the use of the coflex device 
 
To assess post-operative adverse events 
 
To assess post-operative follow-up duration 
 
Secondary Objectives: 
 
To measure and compare patient reported outcomes (e.g., VAS, 
Patient Satisfaction and ODI) at baseline and final follow-up 
 
To measure and compare clinical and radiologic outcomes at baseline 
and final follow-up 
 
To measure and compare the clinical, radiologic, and patient reported 
outcomes at interim follow-up visits 
 
To assess the impact of demographics and risk factors on clinical, 
radiologic, and patient reported outcomes 
 
 
Inclusion Criteria 
Patients must meet the criteria specified in the device labeling including 
radiographic confirmation of at least moderate lumbar stenosis, which 
narrows the central spinal canal at one or two contiguous levels from L1-L5 
that require surgical decompression. 
Exclusion Criteria 
There are no exclusion criteria’s for this study. 

Page 5 of 14 
Version 5.0, 22NOV2016 
 
 
Risk/Benefit 
Assessment 
The study is a retrospective analysis of medical records that poses no risk 
to the patients and minimal risk to loss of patient privacy. All results will be 
de-identified in the process of data review. There are no benefits to the 
subject as this data is being collected to obtain additional clinical evidence 
to support publications and marketing. 

Page 6 of 14 
Version 5.0, 22NOV2016 
 
 
 
Study Abbreviations 
 
 
 
Abbreviation Definition 
BMI 
Body Mass Index 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICH 
International Committee on Harmonization 
IRB 
Institutional Review Board 
MRI 
Magnetic Resonance Imaging 
CT 
Computed Tomography 
DEXA 
Dual Energy X-ray Absorptiometry 

Page 7 of 14 
Version 5.0, 22NOV2016 
 
 
 
1.0   Introduction 
 
 
The coflex® Interlaminar Technology - manufactured by Paradigm Spine - is intended for use 
as a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment 
of moderate to severe lumbar spinal stenosis. The device is specifically designed to provide 
stabilization without fusion in cases of stenosis with or without facet joint hypertrophy, 
subarticular recess stenosis or foraminal stenosis. It is restricted for use to one or two levels 
in the region of L1 – L5. 
 
The height of the neuroforamen is maintained and the facet joints will be relieved. By this a 
further destruction is prevented. Unlike conventional stabilization methods as for example 
spinal fusion, the function of the segment will be maintained and adjacent structures will be 
effectively protected. 
 
Possible risks, which could occur after implantation of the coflex® Interlaminar Technology 
are breakage of the implant, displacement of the implant, pain which is caused by the implant, 
infections, bleedings and hematoma. The benefit of the study lies in the fact that first-time 
retrospective data is raised for potential improvement regarding therapy of lumbar back pain 
with the treatment of the lumbar spinal stenosis, which, in the future, can lead to an 
improvement of the therapy. 
 
In this study, Paradigm Spine will retrospectively collect clinical and radiographic data for 
patients treated with the coflex® Interlaminar Technology during normal conditions of use. 
This data will provide evidence to support publications and marketing. 
 
 
 
2.0   Study Purpose 
 
2.1    Primary Objective 
 
 
 
To assess the operative details and safety outcomes associated with the use of the coflex 
device 
 
To assess post-operative adverse events 
 
To assess post-operative follow-up duration 
 
 
2.2    Secondary Objectives 
 
 
The secondary objectives of this study are:
 
To measure and compare patient reported outcomes (e.g., VAS, Patient Satisfaction and ODI) 
at baseline and final follow-up 
 
To measure and compare clinical and radiologic outcomes at baseline and final follow-up 
 
To measure and compare the clinical, radiologic, and patient reported outcomes at interim 
follow-up visits 
 
To assess the impact of demographics and risk factors on clinical, radiologic, and patient 
reported outcomes 
 
3.0   Eligibility Criteria 
 
3.1    Inclusion criteria 
 

Page 8 of 14 
Version 5.0, 22NOV2016 
 
 
 
Patient considered for enrollment in this study must meet all of the following inclusion criteria: 
 
 
 
Patients must meet the criteria specified in the device labeling including radiographic 
confirmation of at least moderate lumbar stenosis, which narrows the central spinal 
canal at one or two contiguous levels from L1-L5 that require surgical decompression. 
 
 
3.2    Exclusion criteria 
 
 
There are no exclusion criteria for this study. 
 
4.0   Study Design 
 
 
This is a retrospective, multi-center, post-market study collecting clinical, radiographic, and 
patient reported outcomes for subjects who have been treated 1 or 2 levels with the coflex® 
Interlaminar Technology or decompression with or without fusion. 
 
4.1    Endpoints 
 
 
Patient reported outcomes will be assessed as part of the primary objective. 
 
 
Clinical and radiologic outcomes, demographics and risk factors will be assessed as part of 
the secondary objectives. These include, but are not limited to: 
 
Age 
 
Gender 
 
Ethnicity 
 
Height and Weight 
 
BMI 
 
Narcotics use 
 
Comorbidities 
 
Bone Density 
 
Presenting Symptoms 
 
Radiologic Data (Anterior/Posterior and Flexion/Extension films, as well as, MRI and/or 
CT Scan used to confirm diagnosis of spinal stenosis) 
 
Operative Data 
 
Intra-Operative Complications 
 
Return to Work 
 
Changes in Activities of Daily Living (ADL) 
 
Patient Satisfaction 
 
Repeat Surgery Details 
 
 
 
 

Page 9 of 14 
Version 5.0, 22NOV2016 
 
 
 
4.2    Data Collection Summary 
 
Subjects will have undergone a decompression surgery with the coflex® Interlaminar 
Technology, 1 or 2 level decompression with or without fusion according to the physician’s 
standard procedures. Table 1 describes the anticipated time points which will be collected as 
part of the retrospective data review. Please see Section 4.4, Data Collection Procedures for 
additional details regarding the data points intended to be captured at the designated time 
points. 
 
Baseline 
Surgical 
Treatment 
Post-Operative 
Hospital Stay 
Follow-Up 
Visit(s) 
Demographics &  Risk 
Factors 
X 
Prior Surgery Detail (If 
available) 
X 
Diagnosis 
X 
Operative Summary 
X 
Procedure Payer Information 
X 
 
Secondary Treatments 
X 
X 
Complications 
X 
X 
X 
Work Status / ADL (If 
available) 
X 
X 
X 
Patient Questionnaires (If 
available) 
X 
X 
X 
X 
Diagnostic Imaging History 
 
X 
X 
X 
X 

Page 10 of 
14 
Version 5.0, 22NOV2016 
 
 
 
 
4.3    Informed Consent 
 
 
A waiver of informed consent will be requested from the IRB for all subjects as this study is 
collecting retrospective data.  As indicated above, the study is a review of medical records 
that poses no risk to the patients and minimal risk to loss of patient privacy. All individual 
information used in the study will be de-identified and, if published or presented publicly, the 
information will be disclosed in aggregate with no links or identifiers to individual subjects. 
 
4.4    Data Collection Procedures 
 
 
Site staff or a Paradigm Spine representative will review and evaluate medical charts for 
enrollment into the study based on the inclusion/exclusion criteria. All people involved with the 
collection or analysis of the data will be familiar with HIPAA requirements for handling Protected 
Health Information (PHI). For purposes of de-identification, eligible patients (subjects) will be 
given a unique subject identification number that will help to protect their privacy in the study 
records. The research team will not capture any patient-specific identifiers such as date of birth 
or initials in the study records. Data will be entered into CRF’s and then sent to the 
biostatisticians for analysis. 
 
The following data points will be captured at the designated time points. 
 
 
4.4.1  Baseline Visit 
 
    Diagnosis 
o Presenting symptoms 
o Documented failed conservative treatment 
o Patient reported outcome questionnaires, if available 
o Prior treatment details 
 
 
Pre-Operative Demographics 
o 
Date of visit 
o 
Age 
o 
Gender 
o 
Race 
o 
Ethnicity 
o 
Work Status / ADL 
o 
Height (in) 
o 
Weight (lbs) 
o 
BMI 
 
 
 
 
 

Page 11 of 
14 
Version 5.0, 22NOV2016 
 
 
 Risk Factors 
o Tobacco Use 
o Alcohol Use 
o Comorbidities 
o Diabetes 
o Bone Density 
o Medications 
 
 
Diagnostic Imaging 
o MRI and CT of affected lumbar levels 
o Radiographs 
 
 
 
4.4.2  Surgical Treatment Visit 
 
 
Operative Summary 
o Date of surgery 
o Surgical procedure 
o Operative time 
o Estimated blood loss 
o Anesthesia details 
o Treated level(s) 
o Device size 
o Intra-operative/early post-operative complications, such as: 
 
Dural tears 
 
Hematomas 
 
Fractures 
 
Nerve injury 
o Diagnostic imaging History 
o Dictated operative notes 
 
 
Repeat Surgery Summary 
o Date of surgery 
o Reason for surgery (reoperation, revision, removal, etc.) 
o Surgical procedure 
o Operative time 
o Estimated blood loss 
o Anesthesia details 
o Treated level(s) 
o Surgical intervention performed 
o Device size 
o Intra-operative/early post-operative complications 

Page 12 of 
14 
Version 5.0, 22NOV2016 
 
 
 
 
 
Dural tears 
 
Hematomas 
 
Fractures 
 
Nerve injury 
o Diagnostic imaging 
History  
 
 
4.4.3  Post-Operative Hospital Stay 
 
Duration of hospital stay 
 
Post-operative complications and other observations from hospital stay 
 
Patient reported outcome questionnaires, if available 
 
Diagnostic Imaging 
 
Narcotics use 
 
 
4.4.4  Follow-Up Visits 
 
The following longitudinal data will be collected for all follow-up clinic visits through final follow- 
up: 
 
Work status / ADL 
 
Compliance with postoperative protocol/restrictions (if applicable) 
 
VAS (as available) 
 
ODI (as available) 
 
Patient satisfaction (as available) 
 
Complications 
 
Secondary treatments 
 
Narcotics use 
 
Diagnostic Imaging 
 
Incidence of Epidural Steroid Injections (ESI) 
 
 
 
5.0   Statistical Analysis 
 
5.1    General Information 
 
 
All continuous outcome measurements at follow-up time points will be compared to baseline 
values using a t-test for superiority. Categorical outcome measurements will be compared 
using a Fisher’s exact test for superiority. Statistical significance for these analyses will be 
demonstrated with a p-value less than 0.05. 

Page 13 of 
14 
Version 5.0, 22NOV2016 
 
 
 
 
5.2    Primary Endpoint 
 
 
Overall duration of follow-up care and incidence of secondary surgical interventions will be 
analyzed to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology 
 
5.3    Secondary Endpoints 
 
 
The clinical outcomes will be summarized; however, since the collection of these measures is 
not standard of care, this data will only be collected as available. In addition, data will be used 
to analyze the association between coflex® Interlaminar Technology use and outcomes with 
age, ethnicity, race, workers’ compensation, smoking status, and gender.  New and/or 
worsening complications will be summarized. 
 
 
 
6.0   Study Management 
 
6.1    Ethics 
 
 
This study will conform to ethical principles found in the International Committee on 
Harmonization (ICH). The protocol and an Informed Consent waiver will be submitted to the 
IRB for approval.  Sites may use their institutional IRB or if they do not have one, a central 
IRB will be provided by the sponsor.  This Protocol, Informed Consent waiver, and any 
amendments to these documents will be reviewed and approved by the local or central IRB 
and Paradigm Spine prior to beginning data collection.  The Investigator and staff agree to 
conduct the study in compliance with the HIPPA Privacy Rule, applicable 21 CFR regulations 
and the ethical principles found in ICH. 
 
6.2    Data Entry 
 
 
Data for this study will be collected and analyzed by Paradigm Spine representatives who are 
familiar with HIPAA requirements for handling of Protected Health Information (PHI). The 
following measures will be taken to eliminate risk to the privacy of patients whose data is being 
studied for this research: 
 
 
All subject identifying information will be replaced with a unique research identifier to help 
shield the identity of these records within the study database and during data analysis. 
 
Data will be entered into CRF’s by Paradigm Spine representatives. Access to the data 
will be restricted to persons involved with data collection and data review/processing. 

Page 14 of 
14 
Version 5.0, 22NOV2016 
 
 
 
 
 
The key that links the unique research identifier and subject’s identifiable information will 
be securely maintained in a password-protected database with access restricted to key 
personnel responsible for the conduct of this study. It will only be shared if there is a health 
or research justification, or if required by law. 
 
All identifiers will be destroyed at the earliest opportunity consistent with conduct of the 
research, unless there is a health or research justification for retaining the identifiers or 
such retention is otherwise required by law. 
 
Protected Health Information will not be reused or disclosed by the Sponsor to any other 
person or entity, except as required by law, or for authorized oversight of the research 
study.