A Multi-center, Randomized Controlled Study of the Vertos MILD Procedure With Conventional Medical Management Versus Conventional Medical Management Alone in the Treatment of Lumbar Spinal Stenosis.
Phase: NA
Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Sponsor: Vertos Medical, Inc.

Vertos Medical, Inc. 
Confidential 
i 
The MOTION Study 
PROTOCOL TITLE: 
The MOTION™ Study 
SPONSOR: 
Vertos Medical, Inc. 
95 Enterprise, Suite 325 
Aliso Viejo, CA 92656 
SPONSOR CONTACTS: 
Karen Davis 
Vice President of Clinical Research 
Vertos Medical, Inc. 
PURPOSE: 
This study is a prospective, multicenter, randomized controlled 
clinical study examining functional improvement (defined by 
increased activity levels e.g. walking time) in lumbar spinal 
stenosis patients with neurogenic claudication who are treated 
with the MILD® procedure. 
NCT #:                                        NCT03610737
Date:                                          November 18, 2020   
 
 
 
 
 
 
 
 

Vertos Medical, Inc. 
 
 
Confidential 
ii 
The MOTION Study 
 
Table of Contents 
1 
PROTOCOL SYNOPSIS ............................................................................................................. 5 
2 
STUDY DESIGN RATIONALE AND COMPLIANCE ..................................................................... 9 
2.1 
Study Design Rationale ............................................................................................... 9 
2.2 
Study Compliance ....................................................................................................... 9 
3 
TREATMENT DESCRIPTION .................................................................................................. 10 
3.1 
Test Device - MILD .................................................................................................... 10 
3.1.1 
MILD Procedure ........................................................................................................... 11 
3.2 
Conventional Medical Management (CMM) ............................................................. 11 
4 
STUDY OBJECTIVE ................................................................................................................ 11 
 
 
 
 
 
 
5 
STUDY DESIGN ..................................................................................................................... 12 
5.1 
Number of Sites and Subjects ................................................................................... 12 
5.2 
Study Duration .......................................................................................................... 12 
5.3 
Study Population ....................................................................................................... 13 
5.4 
Subject Inclusion/Exclusion Criteria .......................................................................... 13 
5.4.1 
Inclusion Criteria ......................................................................................................... 13 
5.4.2 
Exclusion Criteria ......................................................................................................... 13 
6 
STUDY PROCEDURE ............................................................................................................. 14 
6.1 
Patient Selection and Baseline Visit .......................................................................... 14 
6.2 
Randomization .......................................................................................................... 15 
6.3 
Baseline Assessment ................................................................................................. 15 
6.4 
Treatment ................................................................................................................. 16 
6.4.1 
MILD Procedure plus CMM ......................................................................................... 16 
6.4.2 
CMM Alone.................................................................................................................. 16 
 
 
6.5 
Follow-up Phase ........................................................................................................ 16 
 
 
 
 
6.8 
Pain Management ..................................................................................................... 18 
6.9 
Study Schedule .......................................................................................................... 18 
7 
RISKS / BENEFIT ASSESSMENT ............................................................................................. 19 
7.1 
Risks to Confidentiality of Study Subjects ................................................................. 21 
8 
ADVERSE EVENTS ................................................................................................................. 21 

Vertos Medical, Inc. 
 
 
Confidential 
iii 
The MOTION Study 
 
8.1 
Adverse Event ........................................................................................................... 22 
8.2 
Serious Adverse Event ............................................................................................... 22 
8.2.1 
Serious Adverse Device Effect ..................................................................................... 22 
8.2.2 
Unanticipated Adverse Device Effect .......................................................................... 23 
8.3 
Severity of Adverse Events ........................................................................................ 23 
 
 
8.5 
Reporting of Adverse Events ..................................................................................... 23 
9 
GENERAL STATISTICAL METHODOLOGY .............................................................................. 24 
9.1 
Primary Efficacy Endpoint ......................................................................................... 25 
9.2 
Secondary Endpoints ................................................................................................. 26 
 
 
10 STUDY GOVERNANCE .......................................................................................................... 27 
10.1 Study Principal Investigator (SPI) .............................................................................. 27 
10.2 Medical Monitor (MM) ............................................................................................. 27 
10.3 Clinical Events Adjudicator (CEA) .............................................................................. 28 
11 STUDY MANAGEMENT ......................................................................................................... 28 
11.1 Source Documentation ............................................................................................. 28 
11.2 Data Maintenance and Collection ............................................................................. 29 
11.3 Study Discontinuation ............................................................................................... 29 
11.3.1 Study Discontinuation by IRB ...................................................................................... 30 
11.3.2 Study Discontinuation by Sponsor .............................................................................. 30 
11.3.3 Subject Discontinuation by Investigator ..................................................................... 30 
11.3.4 Withdrawal by Subject ................................................................................................ 30 
11.4 Missed Surveys and Visits ......................................................................................... 31 
11.5 Center Discontinuation ............................................................................................. 31 
11.6 Quality Control/Assurance Procedures ..................................................................... 31 
11.7 On-Site Audits ........................................................................................................... 32 
12 CLINICAL MONITORING ....................................................................................................... 32 
12.1 Study Manual Training .............................................................................................. 33 
12.2 Study Regulatory Binder ........................................................................................... 33 
12.3 Confidentiality and Protection of Study Files and Data ............................................. 33 
12.4 Site Initiation, Monitoring and Close-Out of Clinical Sites ......................................... 34 
13 INVESTIGATOR RESPONSIBILITIES ........................................................................................ 34 
13.1 Required Documents from the Investigators ............................................................ 34 
13.2 Training of Study Center Staff ................................................................................... 35 
13.3 Data Recording .......................................................................................................... 35 
13.4 Adverse Event Reporting ........................................................................................... 35 

Vertos Medical, Inc. 
 
 
Confidential 
iv 
The MOTION Study 
 
13.5 Protocol Adherence / Deviations .............................................................................. 35 
13.6 Amendments / Changes to the Protocol or Treatment Procedure ............................ 35 
13.7 Informing Patient’s Primary Care Physician .............................................................. 36 
13.8 Record Retention ...................................................................................................... 36 
14 ETHICAL AND REGULATORY CONSIDERATIONS ................................................................... 36 
14.1 Role of Study Sponsor ............................................................................................... 36 
14.2 Informed Consent & IRBs (21 CFR Parts 50 and 56) .................................................. 37 
15 REFERENCES ........................................................................................................................ 39 
 

Vertos Medical, Inc. 
 
 
Confidential 
9 
The MOTION Study 
 
2 STUDY DESIGN RATIONALE AND COMPLIANCE 
2.1 STUDY DESIGN RATIONALE 
This is a prospective, multi-center, randomized controlled clinical study examining functional 
improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are 
treated with the MILD procedure plus conventional medical management (CMM) compared to 
those treated with CMM alone, as the control.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The MILD procedure provides minimally invasive lumbar decompression performed 
fluoroscopically through a small 6-gauge port.  MILD is performed with only local anesthetic 
and moderate sedation, and leaves no implants behind.  MILD offers an option for LSS patients 
experiencing symptoms refractory to more conservative therapies.    
2.2 STUDY COMPLIANCE 
In this study, under an IRB-approved patient informed consent, patient-reported outcomes 
over a 24-month study period following treatment will enable an assessment of each patient’s 
functional status.  
 
 
 
 
      
In compliance with the US Federal Regulations, comments regarding product use and 
preference that meet the definition for product complaints should be reported to and 
evaluated by the sponsor. Any occurrence of at least possibly device-related adverse events 

Vertos Medical, Inc. 
 
 
Confidential 
10 
The MOTION Study 
 
will be managed by the investigators, hospital, study principal investigator (SPI), and sponsor 
in accordance with the applicable reporting Regulations. Events arising from the MILD 
procedure meeting the definition of the MDR requirement will be reported to the FDA and the 
IRB where required. Documentation of significant adverse events, including unexpected and 
severe adverse events related to the procedures, will be in compliance with ICH guidelines for 
Good Clinical Practices. 
3 TREATMENT DESCRIPTION 
3.1 TEST DEVICE - MILD 
The MILD devices, manufactured by Vertos Medical, Inc., and procedure will be used in this 
study.  Vertos Medical has received U.S. Food and Drug Administration 510k clearance to 
market the MILD devices for use in lumbar decompression procedures to treat various spinal 
conditions. 
The MILD system is designed to access the interlaminar space from the posterior lumbar spine, 
enabling the user to remove small portions of the lamina and preferentially resect and debulk 
the thickened ligamentum flavum, accomplishing a lumbar decompression. The MILD device 
kit is a sterile, single-use system of surgical tools consisting of the components described in 
Figure 1 below.  
 
 
1. MILD Portal 
5. MILD Bone Sculpter Rongeur 
2. MILD Trocar and Handle 
6. MILD Tissue Sculpter 
3. MILD Portal Stabilizer 
7. MILD Surgical Clamp 
4. MILD Depth Guide 
 
Figure 1: MILD Device Kit 

Vertos Medical, Inc. 
 
 
Confidential 
12 
The MOTION Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5 STUDY DESIGN 
This study is a prospective, multicenter, randomized controlled clinical study examining 
functional improvement (defined by improvement in ODI) in LSS patients with neurogenic 
claudication who are treated with MILD plus CMM compared to those treated with CMM 
alone, as the control.  
 
 
5.1 NUMBER OF SITES AND SUBJECTS 
To ensure that the study is adequately powered, up to 150 subjects will be enrolled at 
approximately 20 sites.  All sites will be located in the United States.  Each participating 
investigational site will be allowed to enroll up to 20 subjects who meet all study eligibility 
criteria.  Additional subjects may be enrolled with sponsor approval. 
5.2 STUDY DURATION 
Subjects who meet the inclusion / exclusion criteria may be enrolled 
 
  
 
 
 
    The screening/baseline visit and CMM 
procedures may take place at the investigator’s medical office.  MILD procedures will be 
performed at the treating ambulatory surgery centers or hospital. Subjects will be requested 
to return for follow-up at a location designated by research staff. 

Vertos Medical, Inc. 
 
 
Confidential 
13 
The MOTION Study 
 
5.3 STUDY POPULATION 
The study population will consist of subjects who are suffering from LSS with neurogenic 
claudication, and who meet the study selection and symptomatic diagnosis criteria. 
5.4 SUBJECT INCLUSION/EXCLUSION CRITERIA 
5.4.1 Inclusion Criteria 
 
1. Age 50-80 
2. Patients experiencing neurogenic claudication symptoms for at least 3 months duration. 
 
 
 
 
 
 
 
. 
 
 
  
3. Patients with comorbid conditions commonly associated with spinal stenosis, such as 
osteophytes, facet hypertrophy, minor spondylolisthesis (Grade I without instability), 
foraminal stenosis, and/or disk protrusion may be included unless the medical monitor and 
the treating physician has determined that the condition is too advanced. 
4. Stable opioid intake with no change during 30 days prior to enrollment. 
5. Available to complete all follow-up visits. 
5.4.2 Exclusion Criteria 
1. ODI Score < 31 (0-100 ODI Scale). 
2. NPRS Score < 5 (0-10 NPRS Scale). 
3. Lumbar epidural steroid injections during eight weeks prior to study enrollment. 
4. Baseline analgesic medication greater than 90 milligram morphine equivalent (MME) per 
day. 
5. Prior surgery at the same treatment level. 
6. Previously received interspinous spacer at the same treatment level. 
7. Previously received intradiscal procedure at the same treatment level. 
8. Previously received vertebral augmentation procedure at the same treatment level. 

Vertos Medical, Inc. 
 
 
Confidential 
14 
The MOTION Study 
 
9. Previously received the MILD procedure at the same treatment level. 
10. Received radiofrequency ablation at the same or the adjacent levels within 6 months prior 
to study enrollment. 
11. History of spinal fractures with current related pain symptoms. 
12. Grade II or higher spondylolisthesis. 
13. Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic 
claudication (e.g. acute compression fracture, metabolic neuropathy, or vascular 
claudication symptoms, etc.). 
14. Unable to walk ≥ 10 feet unaided before being limited by pain.  In this context, ‘unaided’ 
means without the use of a cane, walker, railing, wall, another person or any other means 
of walking assistance. 
15. Previously randomized and/or treated in a similar clinical study. 
16. Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by 
the medical monitor and the physician).  
17. On (or pending) Workman’s Compensation or in active litigation or known to be 
considering litigation associated with back pain. 
6 STUDY PROCEDURE 
6.1 PATIENT SELECTION AND BASELINE VISIT 
Selection begins with a screening process when the patient is examined by their physician. 
Once the investigator has determined that the patient is potentially eligible for treatment in 
the study, the consent should be reviewed with the patient, questions answered, and the 
patient should be asked to sign the Informed Consent document. The eligibility of a patient for 
treatment in this study will be determined after all enrollment criteria have been satisfied.  
 
 
 
 
 
 
 
 Only after these steps are 

Vertos Medical, Inc. 
 
 
Confidential 
15 
The MOTION Study 
 
completed, all enrollment criteria are met and an informed consent signed, will the patient be 
officially enrolled into the study.   
6.2 RANDOMIZATION 
 
  Subjects will be randomly assigned in equal number (1:1) to one of two 
treatment arms: 1) MILD procedure plus CMM or 2) CMM only.  
 
 
  
 
  Based on the information provided, the system will automatically generate the 
assigned treatment.   
6.3 BASELINE ASSESSMENT 
The following baseline assessments for all patients should be confirmed, completed and 
recorded in the medical records and on the appropriate Case Report Forms (CRFs) where 
applicable.  
 
 
 
 
 
  
 
 
  
 
 
  
 
  
 
  
 
   
 
  
 
  
 
 
 
 

Vertos Medical, Inc. 
 
 
Confidential 
16 
The MOTION Study 
 
6.4 TREATMENT 
 
  Subjects will be treated with either MILD 
plus CMM or CMM alone based on randomization results.   
6.4.1 MILD Procedure plus CMM 
Physicians performing the MILD procedures are trained by Vertos on the proper labeling use of 
the MILD devices.  
 
 
 
 
 
6.4.2 CMM Alone   
Study investigator will determine the appropriate CMM therapy or therapies during the course 
of the study for subjects assigned to CMM Alone. 
 
 
 
   
 
 
 
  
 
 
 
 
   
6.5 FOLLOW-UP PHASE 
Subjects will complete all follow-up assessments listed below for each follow-up visit.  
  
 
 
 
 
 
  

Vertos Medical, Inc. 
 
 
Confidential 
17 
The MOTION Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
   
 
 
 
 
  
 
 
 
 
  
 
   
  
 
  
 
  
 
 
 
 
 
 
 

Vertos Medical, Inc. 
 
 
Confidential 
18 
The MOTION Study 
 
 
  
 
 
 
 
  
 
 
 
 
6.8 PAIN MANAGEMENT 
In addition to CMM therapies, investigators may use narcotic and non-narcotic analgesics as 
needed by subjects according to the standard of care and if used for leg/back pain, shall be 
recorded at baseline and follow-up visits on the appropriate CRFs/eCRFs.  
 
 
   
6.9 STUDY SCHEDULE 
   
At baseline, prior therapies will be documented, including frequency, duration, type of therapy 
Documentation of analgesic use for the treatment of neurogenic claudication symptoms will 
include frequency and dosage.  
 
 
 
 
 
Device/Procedure-related unexpected complications and significant adverse events will be 
documented throughout the study period. 
 
 

Vertos Medical, Inc. 
 
 
Confidential 
20 
The MOTION Study 
 
Physical Therapy (PT):  
Passive PT includes heat and 
cold therapy, Iontophoresis, 
tens, and ultrasound.  Active 
PT includes exercise and 
stretching.13 
• Non-surgical therapy that may 
provide relief of lower back and 
limb symptoms in patients with 
neurogenic claudication 
• Muscle strengthening 
• Correction of posture 
• Reduction of inflammation 
• Reduction of muscle spams 
 
• Fatigue 
• Muscle ache 
• Increase lower back 
• Soreness 
• Swelling 
• Increase in localized pain 
• Decrease in immunity due of the 
suppressive effect of the steroid 
Nerve Blocks: 
• Epidural steroid injection: 
Minimally invasive 
procedure that delivers 
steroids into the epidural 
space around spinal nerve 
roots to relieve pain.20  
• Facet joint injection:  
Minimally invasive 
procedure using 
fluoroscopy for guidance 
and delivery of medication 
to relieve pain.14  
• Trigger point injection:  
Minimally invasive 
procedure used to treat 
painful areas of muscle that 
contain trigger points, or 
knots of muscle that form 
when muscles do not 
relax.15 
• Medial branch injection: 
Minimally invasive 
procedure in which an 
anesthetic is injected near 
small medial nerves 
connected to a specific facet 
joint.16 
• Sacroiliac joint injection:  
Minimally invasive 
procedure used either to 
diagnose or treat low back 
pain and/or sciatica 
symptoms associated with 
sacroiliac joint dysfunction.17 
 
• Potential relief of lower limb 
symptoms in patients with 
neurogenic claudication 
• Shorter procedure time versus 
more invasive open or endoscopic 
surgical decompression 
• Quick recovery following treatment, 
which may allow patients to return 
home same day as procedure 
• No requirement for general 
anesthesia 
• Less likelihood of significant 
complications versus open surgical 
procedures. 
• No requirement for sutures 
 
• Increase in localized pain 
• Headaches or fever 
• High blood sugar 
• Decrease in immunity due to the 
suppressive effect of the steroid 
• Increased intraocular pressure or 
cataracts 
• Anxiety/sleeplessness 
• Increased risks of osteoporosis 
• Increased risk of avascular necrosis  
• Exacerbation of diabetes  
• Exacerbation of hypertension 
• Numbness or slight weakness  
• Allergic reaction, rash, itching 
• Weight gain 
• Increase in energy 
• Soreness at injection site  
• Bleeding 
• Infection 
• Worsening of pain symptoms 
• Nerve or spinal cord damage or 
paralysis 
• Shrinkage of fat under skin 
• Death (in rare cases) 
 
Radiofrequency ablation: 
Minimally invasive procedure 
that uses electrical current to 
heat a small area of nerve 
tissue for the purpose of 
• Potential relief of lower limb 
symptoms in patients with low back 
pain 
• Transient sunburn type pain 
• Pain or discomfort around the area 
treated 
• Numbness of skin covering the area 
treated 

Vertos Medical, Inc. 
 
 
Confidential 
21 
The MOTION Study 
 
decreasing pain signals from 
that specific area.18,19 
• Shorter procedure time versus 
more invasive open or endoscopic 
surgical decompression 
• Quick recovery following treatment, 
which may allow patients to return 
home same day as procedure   
• No requirement for general 
anesthesia 
• Less likelihood of significant 
complications versus open surgical 
procedures 
• No requirement for sutures 
 
• Worsened pain due to muscle spasm 
in the area treated 
• Permanent nerve pain 
• Allergies or reactions to medications 
used 
• Infection 
 
MILD Procedure: 
Minimally invasive procedure 
that provides partial 
decompression through the 
removal of tissue and bone 
at the symptomatic level20 
• Potential relief of lower limb 
symptoms in patients with 
neurogenic claudication 
• Shorter procedure time versus 
more invasive open or endoscopic 
surgical decompression 
• Quick recovery following treatment, 
which may allow patients to return 
home same day as procedure 
• No requirement for general 
anesthesia 
• Less likelihood of significant 
complications versus open surgical 
procedures 
• No requirement for sutures 
• Soreness at surgical site 
• Nerve injury (e.g., partial or 
complete paralysis, paresthesia, 
radiculopathy) 
• Injury to adjacent bony or soft 
tissue structures 
• Infection requiring surgical 
intervention 
• Inadequate pain relief 
• Allergic reaction and/or side effects 
from medications (e.g., 
constipation, gastrointestinal 
distress) 
• Dural tear or puncture 
• Bleeding (e.g. epidural hematoma) 
 
7.1 RISKS TO CONFIDENTIALITY OF STUDY SUBJECTS 
Patient confidentiality will be maintained under HIPAA Privacy Rules by de-identifying personal 
subject information and following the applicable Good Clinical Practice guidelines for clinical 
research. 
8 ADVERSE EVENTS 
Subject safety is of the utmost importance. Each investigator has the responsibility for the 
safety of the subjects under his/her care. Throughout the course of the study, all significant 
study related adverse events will be documented and monitored on an adverse event 
CRF/eCRF, including seriousness, severity, treatment, and relationship to the study 
device/procedure. 

Vertos Medical, Inc. 
 
 
Confidential 
22 
The MOTION Study 
 
8.1 ADVERSE EVENT 
An adverse event (AE) is any undesirable experience (sign, symptom, illness, abnormal 
laboratory value, or other medical event) occurring to a patient, whether or not considered 
related to the study product(s) prescribed as part of the protocol, that is identified or worsens 
during a clinical study. Any current condition that is recorded as a pre-existing condition, 
unless there is a change in nature, severity, or degree of incidence, is not an AE.   
 
 
 
 
8.2 SERIOUS ADVERSE EVENT 
A serious adverse event (SAE) is an AE that: 
• Led to death, 
• Led to serious deterioration in the health of the subject, that resulted in  
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent permanent life-threatening 
illness or injury or permanent impairment to a body structure or a body 
function. 
• Led to fetal distress, fetal death or a congenital anomaly or birth defect 
The investigator must determine whether each event meets the definition of a “serious” 
adverse event.  All SAEs must be reported on the CRFs/eCRFs, regardless of relationship, or 
lack thereof, to the device/procedure.  
All other events that are considered medically serious by the investigator should be reported 
immediately to the study sponsor. 
Planned hospitalization for a pre-existing condition, or a procedure required by the protocol, 
without serious deterioration in health, is not considered an SAE. 
8.2.1 Serious Adverse Device Effect 
A serious adverse device effect (SADE) is an adverse device effect that has resulted in any of 
the consequences characteristic of a serious adverse event. An anticipated serious adverse 

Vertos Medical, Inc. 
 
 
Confidential 
23 
The MOTION Study 
 
device effect (ASADE) is an effect which by its nature, incidence, severity or outcome has been 
identified in the risk analysis report. 
8.2.2 Unanticipated Adverse Device Effect 
An unanticipated adverse device effect (UADE) means any serious adverse effect on health or 
safety or 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 study protocol or application (including a supplementary plan or application), 
or any other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects. (21 CFR 812.3 (s)). 
8.3 SEVERITY OF ADVERSE EVENTS 
The severity of an AE is a qualitative judgment of the degree of intensity, as determined by the 
Investigator or as reported by the subject. The severity of the AE should be evaluated 
according to the following scale: 
• 
Mild:  No limitation of usual activities, no therapy or only symptomatic therapy required to 
treat the injury or illness. 
• 
Moderate:  Some limitation of usual activities or specific therapy is required. 
• 
Severe:  Inability to carry out usual activities, hospitalization, emergency treatment, life 
threatening events, or death. 
The assessment of severity should be made independent of the relationship to the 
investigational device and therapy or the seriousness of the event. 
 
 
 
 
 
  
Only those possibly related or definitely related will be reported in EDC for this study unless 
the AE is determined to be an SAE. All SAEs will be reported in EDC regardless of relationship, 
or lack thereof, to the study devices/procedures. 
8.5 REPORTING OF ADVERSE EVENTS 
Subjects will be carefully monitored during the study for possible AEs.  Any AE observed 
should be fully evaluated by the investigator.  Collection of related AEs and all SAEs will 

Vertos Medical, Inc. 
 
 
Confidential 
24 
The MOTION Study 
 
commence from the time the patient has the study procedure.  Routine collection of AEs will 
continue until Study Completion or Termination visit.   
At each study visit, the investigator will assess whether any device/procedure related AEs or 
SAEs have occurred.  Subjects may report AEs occurring at any other time during the study.  
 
All subjects experiencing AEs, whether considered associated with the device and/or 
procedure or not, must be monitored until the symptoms subside and have returned to 
baseline or until there is a satisfactory explanation for the changes observed. All AEs will be 
documented on the Adverse Event CRF, when the investigator concludes the event to be 
either possibly or definitely related to the study device/procedure, and/or the AE is serious.  
The event term, start and stop date and severity will be documented, along with the 
investigator’s opinion of the nature of the causal relationship between the event and the 
device/procedure. 
UADEs have special reporting requirements.  investigator and sponsor will follow adverse 
device effects reporting requirements per CFR Title 21 Part 803: 
Investigator Report:  If a subject experiences an UADE, the investigator must notify sponsor 
within 24-hours of receiving knowledge of the event, and the IRB/EC as soon as possible, but 
no later than the deadline specified by IRB/Ethics Committee (EC) reporting policy. 
Sponsor Report:  UADEs will be reported to FDA, all reviewing IRB/ECs, and participating 
investigators as soon as possible, but no later than 10 working days, after receiving notice of 
the UADE(s). 
As with any AE outside of the study, all AEs should be followed up until resolution or until the 
investigator judges that further follow-up is not necessary.  
The investigator must follow their local IRB policy for AE reporting. Such events may be 
reportable to the FDA under the Medical Device Reporting Regulation. Product complaints 
related to the MILD devices will be documented and investigated per Vertos quality policy. 
9 GENERAL STATISTICAL METHODOLOGY 
All subjects who are treated will be evaluated for safety regardless of whether or not the 
procedure is aborted or the patient withdraws prior to the completion of all post-treatment 
evaluations. 

Vertos Medical, Inc. 
 
 
Confidential 
25 
The MOTION Study 
 
Continuous data will be summarized using descriptive statistics:  mean, standard deviation, 
median, minimum and maximum.  Categorical variables will be summarized using frequency 
counts and percentages.  For events which can occur more than once in a single subject (e.g., 
adverse events), the percentage will be based on subjects experiencing the event, and both 
patient and event counts will be reported.  All hypothesis testing will be performed using a 
two-sided test at a 0.05 level of significance or a one-sided test at a 0.025 level of significance. 
 
Data will be analyzed on an intent-to-treat (ITT) basis, under which analyses will be performed 
according to randomized assignment irrespective of the treatment actually received. 
Consented patients who withdraw consent prior to randomization, or who are found not to 
meet the inclusion/exclusion criteria prior to randomization will not be included in the ITT 
population.  The primary analysis will consist of all available data evaluated under ITT 
principles, referred to in ICH E9 (“Statistical Principles for Clinical Trials”) as the full analysis 
set.  An as-treated analysis will also be performed for the primary efficacy endpoint which will 
report results based on treatment actually received irrespective of randomization. 
9.1 PRIMARY EFFICACY ENDPOINT 
The study will test the hypothesis that the primary endpoint among subjects randomized to 
the MILD arm will have superior (that is, more favorable changes on the ODI) outcomes 
compared to those randomized to CMM. Rejection of the below null hypothesis is consistent 
with the superiority of the MILD treatment: 
 
 
 
 
 
H0: µMILD - µCMM ≤ 0 
 
 
 
 
 
HA: µMILD - µCMM > 0 
where µMILD and µCMM are the mean values of the primary endpoint as defined above, for 
subjects in the MILD and CMM groups, respectively.  Since lower scores represent favorable 
outcomes in the ODI scoring system, the endpoint is defined using baseline score minus 
follow-up score, so that positive values indicate improvement from baseline. 
 

Vertos Medical, Inc. 
 
 
Confidential 
27 
The MOTION Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10 STUDY GOVERNANCE 
10.1 STUDY PRINCIPAL INVESTIGATOR (SPI) 
During the course of the study, the SPI will: 
• Oversee clinical trial activities including protocol development, and any changes that may 
be desired or required during conduct of the study. 
• Assist in obtaining evaluation and feedback from peers throughout the course of the study.  
• Review and approve protocol and site selection. 
• Register the study protocol on ClinicalTrials.gov prior to enrollment of first patient. 
• Direct and support site investigators. 
• Perform comprehensive periodic review and assessment of patient enrollment, study data 
and protocol compliance. 
• Oversee safety of adverse event reporting.  
• Report study results on ClinicalTrials.gov within 1 year of study completion. 
• Support publication of study results in peer-reviewed journal within 1 year of study 
completion. 
10.2 MEDICAL MONITOR (MM) 
The MM will be an Individual who is knowledgeable in the appropriate disciplines and medical 
specialties pertinent to the disease state being evaluated in this clinical Study. The MM will be 
a qualified medical practitioner who has experience and training in the MILD device and 
procedure. During the course of the study, the MM will:  
• Review all subject medical records, baseline imaging to confirm the diagnosis and the 
appropriate level(s), Measure the thickness of ligamentum flavum at the treatment 
level(s). Also, ensure that eligibility criteria are met prior to randomization. 
• Monitor overall study safety. 
• Approve patient enrollment including review of MRIs. 
• Respond to patient safety related inquiries from members of the Clinical Team including, 
but not limited to: patient eligibility, prohibited medications or procedures, exclusionary 
medical history, adverse events, and protocol deviations that impact patient safety. 
• Participate in protocol development and amendment review. 

Vertos Medical, Inc. 
 
 
Confidential 
28 
The MOTION Study 
 
• Perform comprehensive periodic review and assessment of patient enrollment, study data 
and protocol compliance. 
• Prepare and/or review SAE narratives if applicable. 
• Ensure adequate documentation of safety decisions. 
• Escalate safety events as necessary. 
• Consult with other study advisors as needed for safety issues requiring additional input. 
• Support publication of study results in peer-reviewed journal within 1 year of study 
completion. 
10.3 CLINICAL EVENTS ADJUDICATOR (CEA) 
The CEA will be an individual who is independent of the Investigational Sites.  The CEA will be 
responsible for the review and validation of all complications that occur over the course of the 
Study and the subsequent classification of these complications as related to the device or 
procedure.  The CEA will review all complications and adjudicate them as defined in Section 8: 
Adverse Events.  The CEA can request additional source documentation and any available 
imaging to assist with adjudication. 
11 STUDY MANAGEMENT 
11.1 SOURCE DOCUMENTATION 
All required data for this study is to be recorded in the subject’s medical chart for source 
documentation and data verification.  Clinical research coordinators (CRC) at each site will 
perform primary data collection from source documents (reviews prior to transcribing onto 
Case Report Forms (CRFs), or eCRFs. Source data includes original records of clinical findings, 
observations, or other activities in a clinical trial.  Examples of these original documents and 
data records include: hospital records, clinical and office charts, laboratory notes, memoranda, 
subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from 
automated instruments, copies or transcriptions certified after verification as being accurate 
and complete, microfiches, photographic negatives, x-rays, and subject files. 
The investigator is ultimately responsible for the integrity of the data recorded and submitted 
on the CRFs/eCRFs; therefore, each CRF/eCRF must be reviewed and signed by the 
investigator.  To protect subject confidentiality, the subject’s name must not appear anywhere 
on the CRF/eCRF, and must be removed or redacted from any supporting documentation.  
Each page should be identified with the subject’s study ID number and initials only.  All other 
subject identifiers (e.g. medical record number, social security number) are to be obscured. 
CRFs/eCRFs will be completed in a timely fashion.   

Vertos Medical, Inc. 
 
 
Confidential 
29 
The MOTION Study 
 
Regulations require that investigators maintain information for every subject participating in 
the clinical study, in the study subject’s medical records that corroborate data collected on the 
CRFs/eCRFs.  In order to comply with these regulatory requirements, the following information 
will be maintained and made available as required to monitors and/or regulatory inspectors: 
• Medical history and physical condition of the study subject before involvement in the 
study sufficient to verify protocol entry criteria (if not already present). 
• Dated and signed notes in the subject’s medical record on the day of entry into the 
study that identify: signed study Informed Consent, the participant’s date of entry into 
the study, the study sponsor, the clinical site, the subject number assigned and a 
statement that informed consent was obtained. It must be possible for the investigator 
and the hospital personnel to identify each patient by using this participant’s file. If the 
participant’s data is recorded electronically, the investigator should assure hard-copies 
are filed on a regular basis. 
• Dated and signed notes from each study participant visit with reference to the 
CRFs/eCRFs for further information, if appropriate (for specific results of procedures 
and exams). 
• Completed study questionnaire surveys. 
• Notes regarding narcotic and non-narcotic analgesics taken during the study. 
• Documentation of co-interventions used during the study. 
• Study participant’s condition upon completion of or withdrawal from the study. 
• Documentation is required to show reasons patients failed screening, along with their 
signed informed consent form. 
11.2 DATA MAINTENANCE AND COLLECTION 
The applicable data recorded in this study shall be documented on CRFs/eCRFs that have been 
specifically designed for this study. The CRFs/eCRFs will then be recorded, evaluated, and 
stored in accordance with data protection regulations. The CRFs/eCRFs are documents that 
must be suitable for submission to regulatory authorities should this become necessary to 
support changes to the product labeling in future regulatory agency submissions.  
11.3 STUDY DISCONTINUATION 
The clinical study can be discontinued prematurely at the discretion of the IRB or sponsor.  
Subjects may withdraw from the study at any time upon request, or they may be withdrawn at 
any time at the discretion of the PI or sponsor for safety, or administrative reasons. 

Vertos Medical, Inc. 
 
 
Confidential 
30 
The MOTION Study 
 
11.3.1 Study Discontinuation by IRB 
The IRB may choose to discontinue the study at any center(s) for which they granted approval 
if: 
• The research study is not conducted in accordance with the IRB’s requirements 
• The research study indicates unexpected serious harm to subjects 
11.3.2 Study Discontinuation by Sponsor 
The sponsor may choose to discontinue the study if the sponsor discovers additional 
information during the study that may cause harm to subject safety.  If the study is terminated 
prematurely or suspended, the sponsor will promptly inform all clinical investigators of the 
termination or suspension and the reason(s) for this action. The IRB/EC will also be informed, 
either by the sponsor or investigator if a local IRB/EC is utilized, promptly and provided with 
the reason(s) for the termination. If applicable, regulatory authorities will be informed. 
11.3.3 Subject Discontinuation by Investigator 
An investigator may discontinue a subject from the study, with or without the subject’s 
consent, for any reason that may, in the investigator’s opinion, negatively affect the wellbeing 
of the subject.  Reasons to discontinue may include, but are not limited to the following:  
• Poor compliance 
• Occurrence of an adverse experience that is unacceptable to the subject 
• Investigator determination that it is in the subject's best interest due to health 
issues unrelated to LSS 
If a subject is withdrawn from the study, the investigator will promptly inform the subject and 
sponsor. 
11.3.4 Withdrawal by Subject 
If a subject chooses to withdraw from the study, and also withdraws consent for disclosure of 
future information, no further evaluation(s) should be performed, and no additional data will 
be collected. The sponsor may retain and continue to use any data collected prior to the 
withdrawal of consent, unless specified by the subject. 
If early termination is due to death or injury from a device or procedural-related AE, the 
investigator will evaluate it as a potential medical device event. If it is determined to be a 
device-related failure, the investigator and sponsor will report it per the regulations (21 CFR 
803).  

Vertos Medical, Inc. 
 
 
Confidential 
31 
The MOTION Study 
 
11.4 MISSED SURVEYS AND VISITS 
For compliance, each subject is instructed on the importance of complying with the directions 
for treatment and medication, pain and function questionnaires, and the follow-up office visit 
schedule. Any subject who does not complete their surveys and/or return for a scheduled 
follow-up visit should be contacted by the site study personnel to determine the reason. An 
assessment of whether the missed visit was associated with a device/procedure related 
problem, an unrelated medical problem, or a non-medical problem will be made. Written 
documentation of the study site’s efforts to locate and/or gain compliance from a “lost to 
follow-up” subject must be maintained.  
11.5 CENTER DISCONTINUATION 
Study center participation can be discontinued and the study closed in case of insufficient 
recruitment of patients, recall of any MILD device, continuous non-compliance with the 
protocol, or continuous non-compliance with IRB requirements.   
11.6 QUALITY CONTROL/ASSURANCE PROCEDURES 
The investigator and identified personnel are expected to ensure that all aspects of the 
protocol are followed, results are accurately recorded, all device/procedure related AEs are 
reported, and appropriate record keeping is performed.  They will also verify that the 
CRFs/eCRFs are in agreement with the applicable patient medical records. 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 

Vertos Medical, Inc. 
 
 
Confidential 
32 
The MOTION Study 
 
When subjects are enrolled who fail to meet the inclusion/exclusion criteria or who have not 
signed an informed consent, the site will notify the IRB, as well as the sponsor, and the SPI. 
Continued enrollment of subjects who do not meet the inclusion/exclusion criteria or who are 
not properly consented, may result in the investigator being suspended from further 
participation in the trial; however, compliance with clinical follow-up on subjects previously 
enrolled will still be required. 
11.7 ON-SITE AUDITS 
Representatives of the IRB or the sponsor (or designee) may visit the study site to carry out an 
audit of the study in compliance with regulatory guidelines and company policy.  Such audits 
will require access to all study records including source documents, CRFs/eCRFs, and other 
study documents.  Direct access to these study records must be guaranteed by the 
investigator, who must provide support for these activities at all times. 
Similar auditing procedures may also be conducted by agents of any Regulatory Authority 
reviewing the results of this study.  The investigator/institution should immediately notify the 
sponsor if they have been contacted by a Regulatory Authority concerning an upcoming 
inspection. 
12 CLINICAL MONITORING 
A designated CRC will be assigned by the investigator. Good Clinical Practices will be 
implemented for this study. The sponsor or designee will review the CRFs/eCRFs for 
completeness and assess them for any product complaints, potential adverse events, and/or 
medical device reports per the FDA regulations. Any missing entries in the CRFs/eCRFs, or 
protocol compliance issues will be brought to the investigator’s or CRC’s attention for 
correction.  
The sponsor or its designee will conduct ongoing monitoring of each site to assess enrollment 
commitments and the accurate and timely submission of data forms.  As the study proceeds, 
the investigators will closely monitor compliance with the protocol. 
The investigator will 
accommodate adequate time for such monitoring activities.  The investigator will also ensure 
that the monitor or other compliance or quality assurance reviewer is given access to all of the 
above-noted study-related documents and study related facilities, and has adequate space to 
conduct the monitoring visit. 

Vertos Medical, Inc. 
 
 
Confidential 
33 
The MOTION Study 
 
12.1 STUDY MANUAL TRAINING 
The training of appropriate clinical site personnel in CRFs/eCRFs completion will be the 
responsibility of the sponsor.  To insure uniform data collection, the sponsor or its designee 
will review the Study Binder with the CRC.  All CRCs will undergo adequate training to become 
thoroughly familiar with the following items: 
 
 
 
 
 
 
 
 
 
 
 
 
 
12.2 STUDY REGULATORY BINDER 
The CRC at each site will be trained on the proper maintenance of the Study Regulatory 
Binder.  All correspondence, agreements, and logs are to be kept up to date and should be 
forwarded to the sponsor in a timely fashion.  The contents of the Study Regulatory Binder 
may include: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12.3 CONFIDENTIALITY AND PROTECTION OF STUDY FILES AND DATA 
The sponsor is dedicated to maintaining the confidentiality and privacy of subjects who 
volunteer to participate in the study; therefore, HIPAA Privacy Rules will be adopted and 
adhered to throughout the study.  Passwords are issued to appropriate personnel to insure 

Vertos Medical, Inc. 
 
 
Confidential 
34 
The MOTION Study 
 
confidentiality and protection of the database by allowing variable levels of access to the 
computer system.  The hard copies of the CRFs/eCRFs and source documentation are to be 
maintained in a secure area with limited access.  All patient identifiers will be redacted from all 
photocopies of source documents removed from the site.  Patient identifiers include, but are 
not limited to:  subject’s name, social security number, and medical number.  All study 
documents will identify the subject by a subject ID# assigned by the sponsor and by the 
subject’s initials (first, middle, last). 
12.4 SITE INITIATION, MONITORING AND CLOSE-OUT OF CLINICAL SITES 
The monitor for this study is the sponsor or its designee.  The study will be monitored to 
ensure that applicable FDA regulations are followed.  This includes, but is not limited to, the 
following sections of the Code of Federal Regulations: 21 CFR Part 812, Investigational Device 
Exemption; 21 CFR Part 50, Protection of Human Subjects, 21 CFR Part 54, Financial Disclosure 
by Clinical Investigators and 21 CFR Part 56, Institutional Review Boards. 
Prior to subject enrollment, a study initiation visit, web-conferencing training, and/or 
telephone call (if appropriate), will be completed at each clinical site to ensure the following:  
IRB approval has been obtained and documented; the investigators and study personnel are 
appropriately trained and clearly understand the study, the investigators and study personnel 
accept the obligations incurred in undertaking this clinical investigation. 
Periodic monitoring visits will be made at all active study sites throughout the study to assure 
that the investigator obligations are fulfilled and all applicable regulations and guidelines are 
being followed.  These visits will assure that the facilities remain acceptable; the protocol is 
being followed, the IRB has been notified of approved protocol changes as required, complete 
records are being maintained, appropriate and timely reports have been made to the sponsor 
and the IRB, and the investigator is carrying out all agreed activities.  
13 INVESTIGATOR RESPONSIBILITIES 
The investigator shall be responsible for ensuring that the study is performed in accordance 
with the protocol, the practice of medicine, the medical device laws, patient data and/or 
privacy protection regulations and applicable country and local regulatory requirements. 
13.1 REQUIRED DOCUMENTS FROM THE INVESTIGATORS 
All investigators must be approved in advance by the SPI and trained by the sponsor. Each site 
investigator must provide the following documents prior to the start of the study: 

Vertos Medical, Inc. 
 
 
Confidential 
35 
The MOTION Study 
 
 
 
 
 
 
 
 
 
13.2 TRAINING OF STUDY CENTER STAFF 
It is the investigator’s responsibility to ensure that all Sub-investigators and other staff 
assisting with the study have appropriate qualifications and are fully instructed on the study 
procedures. investigator shall ensure that there is an experienced CRC for the study, and that 
the investigator and staff have adequate time to conduct the study. 
13.3 DATA RECORDING 
The CRFs/eCRFs should be a complete and accurate record of the patient’s data collected 
during the study according to Good Clinical Practice recommendations.  The investigator is 
responsible for the quality of the data collected, corrected, and recorded. 
13.4 ADVERSE EVENT REPORTING 
It is the investigator’s responsibility to promptly report all device/procedure related AEs 
and/or SAEs occurring during the study to the SPI and to inform their IRB as required. 
13.5 PROTOCOL ADHERENCE / DEVIATIONS 
The protocol, as written, must be followed.  If the medical condition of a patient necessitates 
a major deviation from the protocol, the protocol deviation must be approved by the SPI and 
clearly documented. 
13.6 AMENDMENTS / CHANGES TO THE PROTOCOL OR TREATMENT PROCEDURE 
During the course of the study, an amendment to the protocol may be necessary. Only the 
sponsor is allowed to amend this protocol. Any amendments or modifications must be 
approved by the research site’s IRB/EC prior to research-study staff implementation, unless 
the modifications increase subject safety. The research sites will receive the following for their 
regulatory file, and if applicable, IRB/EC submission: 
 
 
 
 
 
 

Vertos Medical, Inc. 
 
 
Confidential 
36 
The MOTION Study 
 
 
 
Any amendment(s) that affect the informed consent require a revised, sponsor and IRB/EC-
approved informed consent, before changes in study procedures are implemented. These 
requirements should in no way prevent any immediate action from being taken by the 
investigator or by the sponsor to preserve the safety of any subjects included in the study, as 
necessary. If an immediate change to the protocol is felt to be necessary by the investigator 
and is implemented by him/her for safety reasons, the sponsor should be immediately 
notified. 
13.7 INFORMING PATIENT’S PRIMARY CARE PHYSICIAN 
It is the investigator’s responsibility to notify the primary care or referring physician of the 
patient’s participation in the study. 
13.8 RECORD RETENTION 
It is the investigator’s responsibility to ensure that the data sources, CRFs/eCRFs, and study 
patient files are stored securely during and after the study termination for a minimum 2-year 
period, or longer, if designated by the IRB.  Such materials must be accessible for auditing by 
regulatory authorities.  They may be discarded only upon notification from sponsor.  To avoid 
error, the investigator should contact sponsor before the destruction of any records and 
reports pertaining to the trial to ensure they no longer need to be retained.  In addition, 
sponsor should be contacted if the investigator plans to leave the clinical site so that 
arrangements can be made for transfer of records. 
14 ETHICAL AND REGULATORY CONSIDERATIONS 
14.1 ROLE OF STUDY SPONSOR 
As the study sponsor of this clinical study, sponsor has the overall responsibility for the 
conduct of the study, including assurance that the study meets the regulatory requirements of 
the Food and Drug Administration.  In this study, sponsor and/or its designee will have certain 
direct responsibilities and will delegate other responsibilities as applicable. Sponsor and/or its 
designee will ensure adherence to the sponsor general duties (21 CFR Part 812.40), selection 
of investigators (21 CFR Part 812.43), monitoring (21 CFR Part 812.46), and maintaining 
records [21 CFR Part 812.140 (b)]. 

Vertos Medical, Inc. 
 
 
Confidential 
37 
The MOTION Study 
 
14.2 INFORMED CONSENT & IRBS (21 CFR PARTS 50 AND 56) 
All subjects must provide written informed consent in accordance with the local clinical site’s 
IRB.  A copy of the consent form from each center must be forwarded to sponsor for review 
and approval prior to submitting it to the IRB.  Each site must provide the sponsor with a copy 
of the clinical site’s IRB approval letter (stating the study name, protocol revision being 
approved and an approval date) and the informed consent.  Yearly approvals for the 
continuation of the trial at each clinical site must also be forwarded to the sponsor. 
An unconditional prerequisite for participation of a patient in the clinical study is his/her 
consent after having been informed about the following basic elements of Informed Consent 
in accordance with the Declaration of Helsinki, with reference to the USA Code of Federal 
Regulations 21CFR50.25.a.:  
1. A statement that the study involves research, an explanation of the purposes of the 
research, and the expected duration of the subject’s participation, a description of the 
procedures to be followed, and identification of any procedures which are 
experimental. 
2. A description of any reasonably foreseeable risks or discomforts to subjects. 
3. A description of any benefits to the subject or to others which may reasonably be 
expected from the research. 
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that 
might be advantageous to the subject. 
5. A statement describing the extent, if any, to which confidentiality of records identifying 
the subject will be maintained and that notes the possibility that the regulatory 
authorities and study sponsor may inspect the records. 
6. For research involving more than minimal risk, an explanation as to whether any 
compensation is available and an explanation as to whether any medical treatments 
are available if injury occurs and, if so, what they consist of or where further 
information may be obtained. 
7. An explanation of who to contact for answers to pertinent questions about the 
research and research subjects' rights, and who to contact in the event of a research-
related injury to the subject. 
8. A statement that participation is voluntary, that refusal to participate will involve no 
penalty or loss of benefits to which the subject is otherwise entitled, and that the 

Vertos Medical, Inc. 
 
 
Confidential 
38 
The MOTION Study 
 
subject may discontinue participation at any time without penalty or loss of benefits to 
which the subject is otherwise entitled. 
The following statement shall be provided to each clinical trial subject in informed consent 
documents and processes. This will notify the clinical trial subject that clinical trial information 
has been or will be submitted for inclusion in the clinical trial registry databank under 
paragraph (j) of section 402 of the Public Health Service Act. The statement is: "A description 
of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time." 
The investigators must inform the patient both verbally and in writing.  The wording must be 
chosen so that lay persons may fully and readily understand the content. 
It is the responsibility of the investigators to give to each patient, prior to inclusion in the 
study, full and adequate information regarding the objectives and the procedures of the study 
and the possible risks and benefits involved.  Furthermore, it is the responsibility of the 
investigators to obtain a signed informed consent from all patients prior to inclusion in the 
study.  Sponsor and the IRB must approve any modification to the sample Patient Informed 
Consent made by the study site.  The study center must provide sponsor with a copy of the 
IRB approved informed consent and renewed approvals and consents as appropriate for the 
duration of the study. 
The original informed consent should be retained in the patient’s study records, and a 
signed/dated copy provided to the patient. 
 
 

Vertos Medical, Inc. 
 
 
Confidential 
39 
The MOTION Study 
 
15 REFERENCES 
 
1  Sandella DE, DE, Haig AJ, Tomkins-Lane C, Yamakawa K. Defining the clinical syndrome of 
lumbar spinal stenosis: A recursive specialist survey process. PMR 2013;5,491-495. 
2  Park JB, Chang H, Lee JK. Quantitative analysis of transforming growth factor-beta 1 in 
ligamentum flavum of lumbar spinal stenosis and disc herniation. Spine 2001;26:E492–
E495. 
3   Staal JB, de Bie R, de Vet DCW, Hildebrandt J, Nelemans P. Injection therapy for subacute 
and chronic low-back pain: an updated Cochrane review. Spine 2009;34:49–59. 
4  Manchikanti L, Cash KA, McManus CD, Pampati V, Abdi S. Preliminary results of a 
randomized, equivalence trial of fluoroscopic caudal epidural injections in managing 
chronic low back pain: part 4—spinal stenosis. Pain Physician 2008;11:833–848. 
5  Friedly J, Chan L, Deyo R. Geographic variation in epidural steroid injection use in medicare 
patients. J Bone Joint Surg Am 2008;90:1730–1737. 
6   Friedly J, Chan L, Deyo R. Increases in lumbosacral injections in the medicare population. 
Spine 2007;32:1754–1760. 
7  Abdi S, Datta S, Trescot AM, et al. Epidural steroids in the management of chronic spinal 
pain: a systematic review. Pain Physician 2007;10:185–212. 
8   Fairbank NCT, Pynsent PB. The Oswestry Disability Index. Spine 2000;25(22):2940-2953. 
 
9  Chopko B, Caraway DL. MiDAS I (mild® decompression alternative to open surgery): a 
preliminary report of a perspective, multi-center clinical study. Pain Physician 2010; 
13:369-378. 
 
10 Mekhail N, Vallejo R, Coleman MH, et al. Long-term results of percutaneous lumbar 
decompression mild for spinal stenosis. Pain Practice 2012; 12: 184-193. 
 
11 Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin 
Nur 2005;14(7):798-804. 
 
12 Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. 
Measurement of exercise tolerance on the treadmill in patients with symptomatic lumbar 
spinal stenosis: a useful indicator of functional status and surgical outcome. J Neurosurg 
83:27–30, 1995. 
13 Dirckman, RD (2005, December 20) Physical Therapy for Low Back Pain Relief. 
https://www.spine-health.com/treatment/physical-therapy/physical-therapy-low-back-
pain-relief. 
 

Vertos Medical, Inc. 
 
 
Confidential 
40 
The MOTION Study 
 
 
14 Baker, RM (2013, March 22) Facet joint injection procedure. https://www.spine-
health.com/treatment/injections/facet-joint-injection-procedure. 
 
15 Driver, CB (2018, May 22) Trigger Point Injection. 
https://www.medicinenet.com/trigger_point_injection/article.htm#trigger_point_injectio
n_tpi_facts. 
 
16 Baker, RM (2013, October  04) Medical branch block results. https://www.spine-
health.com/treatment/injections/medial-branch-block-results. 
 
17 Patel, AR (2012, January 24) Sacroiliac Joint Injection.  https://www.spine-
health.com/treatment/injections/sacroiliac-joint-injection. 
 
18 Baker, RM (2013, May 24) Radiofrequency ablation procedure. https://www.spine-
health.com/treatment/injections/radiofrequency-ablation-procedure. 
 
19 Shealy, C. Norman. "Facet Denervation in the Management of Back and Sciatic 
Pain." Clinical Orthopaedics and Related Research, no. 115 (March/April 1976): 157-64. 
 
20 Benyamin RM, Staats PS. MiDAS ENCORE: Randomized controlled study design and 
protocol. Pain Physician 2015; 18:307-316. 
 
21 Staats PS, Benyamin RM. MiDAS ENCORE: Randomized controlled clinical trial report of 6-
month results. Pain Physician 2016; 19:25-37. 
 
22 Benyamin RM, Staats PS. MILD is an effective treatment for lumbar spinal stenosis with 
neurogenic claudication: MiDAS ENCORE randomized controlled trial. Pain Physician 2016; 
19:229-242. 
 
23 Sturesson B, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Dengler J. Six-month 
outcomes from a randomized controlled trial of minimally invasive SI joint fusion with 
triangular titanium implants vs conservative management. Eur Spine J 2017 26:708-719. 
 
24 Whang P, Cher D, Polly D, Frank C, Lockstadt, H., Glaser J.,Limoni R, and Sembrano, MD, 
Sacroiliac Joint Fusion Using Traiangular Titanium Implants vs Non-Surgical Management: 
Six-month Outcome from a Prospective Randomized Controlled Trail. International J of 
Spine Surgery 2006 9:6. 
 
25 Weinstein JN, Tosteson RD, Lurie JD, Tosteson ANA, Blood E, Hanscom B, Herkowitz H, 
Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H, for the SPORT 
Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med 
2008; 358:794-810.