Study of the Efficacy and Tolerance of the B-Dyn Medical Device Compared to a Conventional Bolted Fusion With or Without Cage in the Treatment of Degenerative Lumbar Stenosis, With or Without Grade I Spondylolisthesis on the Degree of Postoperative Functional Disability, Preservation of Mobility and Prevention of the Adjacent Syndrome". Interventional, Prospective, Comparative, Randomized, Non-inferiority, Single Blind, International, Multicenter Clinical Study
Phase: NA
Conditions: Degenerative Lumbar Spinal Stenosis
Sponsor: Quanta Medical

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                                                        BDYNCLIN STUDY 
10/04/2020 
V2-0 PROTOCOL 
“Study of the efficacy and tolerance of the B-Dyn medical device compared to a conventional bolted 
fusion with or without cage in the treatment of degenerative lumbar stenosis, with or without grade I 
spondylolisthesis on the degree of postoperative functional disability, preservation of mobility and 
prevention of the adjacent syndrome". 
Interventional, prospective, comparative, randomized, non-inferiority, single blind, international, 
multicenter clinical study. 
Document approved for broadcasting : 
10/04/2020 
By : Docteur O. ZOURABICHVILI 
 
President 
Visa : 
 
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PROTOCOL NUMBER 
3001_BDYNCLIN 
DATE  
10/04/2020 
AUTHORS 
Pr Vincent POINTILLART (CHU Bordeaux),  
Dr Bertrand DEBONO (Clinique des Cèdres)    
Dr Othar ZOURABICHVILI (QUANTA MEDICAL)  
Rym BOULKEDID (QUANTA MEDICAL) 
 
 
 
 
 
This document contains confidential information belonging to QUANTA MEDICAL. Except as otherwise agreed 
to in writing, by accepting or reviewing this document, you agree to hold this information in confidence and not 
copy or disclose it to others (except where required by applicable law) or use it for unauthorized purposes. In 
the event of any actual or suspected breach of this obligation, QUANTA MEDICAL must be promptly notified. 
Confidential 
Release 

 
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PROTOCOL 
“Study of the efficacy and tolerance of the B-Dyn medical device compared to a conventional bolted 
fusion with or without cage in the treatment of degenerative lumbar stenosis, with or without grade I 
spondylolisthesis on the degree of postoperative functional disability, preservation of mobility and 
prevention of the adjacent syndrome". 
Interventional, prospective, comparative, randomized, non-inferiority, single blind, international, 
multicenter clinical study. 
 
Proponent Reference :3001_BDYNCLIN 
 
 
N° ID RCB : 2020-A00553-36 
 
 
 
Indication: degenerative lumbar spinal stenosis 
 
 
  
Phase :  III 
 
 
  
 
 
ICH / GCP Declaration: 
This study will be conducted in accordance with the ICH/GCP and the NF EN ISO-14155 
May 2012 norms, specifically on clinical investigations regarding the medical devices in 
human subjects, and the revision 3 MEDDEV 2.7/3 (May 2015) on SAE reporting. 
The research has received a favorable opinion from the Ethical committee XXXXX on the. 
 
COORDINNATING INVESTIGATOR (Orthopaedics) 
COORDINNATING INVESTIGATOR (Neurosurgery) 
Pr. Vincent POINTILLART 
Department of Orthopaedic and Trauma Surgery 
Spinal Surgery Unit 
CHU [University Hospital Center]of Bordeaux – Le Tripode 
– GH Pellegrin 
Place Amélie Raba-Léon 
33000 BORDEAUX 
Dr Bertrand Debono 
Neurosurgery – Neuroscience cluster. 
Clinique des Cèdres - Bat. 2 
31700 Cornebarrieu 
 
 
 
PROPONENT 
MONITOR 
COUSIN BIOTECH 
Allée des Roses 
59117 Wervicq sud 
QUANTA MEDICAL 
16 avenue des Châteaupieds 
92500 Rueil Malmaison 

 
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TABLE OF CONTENTS 
1. 
ABBREVIATIONS – DEFINITIONS 
7 
1.1. 
ABBREVIATIONS 
7 
1.2. 
DEFINITIONS 
7 
2. 
addresses and responsibilities 
8 
2.1. 
protocol signatorIES 
8 
2.2. 
protocol signature page 
9 
3. 
SYNOPSIS 
10 
4. 
SCIENTIFIC JUSTIFICATION AND GENERAL DESCRIPTION OF THE RESEARCH 
19 
4.1. 
NAME AND DESCRIPTION OF THE MEDICAL DEVICE TO WHICH THE RESEARCH RELATES 
19 
4.2. 
DESCRIPTION AND JUSTIFICATION OF THE USE OF THE MEDICAL DEVICE AND THE TREATMENT TIME 
21 
4.3. 
DETAILED DESCRIPTION OF THE USE OF THE DEVICE TO WHICH THE RESEARCH RELATES AND OF THE 
SURGICAL PROCEDURES 
21 
4.4. 
SCIENTIFIC JUSTIFICATION OF THE RESEARCH 
22 
5. 
OBJECTIVES OF THE STUDY 
24 
5.1. 
MAIN OBJECTIVE 
24 
5.2. 
SECONDARY OBJECTIVES 
24 
6. 
STUDY DESIN 
25 
6.1. 
EVALUATION CRITERIA 
25 
6.1.1. 
PRIMARY ENDPOINT 
25 
6.1.2. 
SECONDARY ENDPOINTS 
25 
6.2. 
RESEARCH METHODOLOGY 
26 
6.2.2. 
PARTICIPATION SITES 
2 
6.3. 
MEASURES TAKEN TO REDUCE AND AVOID BIAS 
2 
6.3.1. 
RANDOMIZATION 
2 
6.3.2. 
BLINDING 
2 
6.3.3. 
BLIND REVIEW 
3 
6.4. 
MODALITIES FOR USING THE DEVICES ON WHICH THE RESEARCH IS RELATED AND THE SURGICAL 
PROCEDURES INVOLVED IN THE IMPLEMENTATION OF THE DEVICE IN THE RESEARCH 
3 
6.4.1. 
THE B-DYN® DEVICE 
3 
6.4.2. 
THE BOLTED FUSION TECHNIQUE WITH OR WITHOUT CAGE 
3 
6.5. 
PROCESS AND DURATION OF INDIVIDUALS PARTICIPATION 
3 
6.5.1. 
PROCESS FOR A PATIENT 
3 
6.5.1.1. 
VISITS V1 – INCLUSION VISIT 
3 
6.5.1.2. 
VISIT V2 – INTERVENTION AND POST-OPERATIVE FOLLOW-UP 
4 
6.5.1.3. 
VISIT V3 –2ND MONTH POST-SURGERY (± 7 DAYS), 
4 
6.5.1.4. 
VISIT V4 – 12TH MONTH (D365± 30 DAYS), 
5 
6.5.1.5. 
VISIT V5 – 60TH MONTH (D365± 30 DAYS), 
5 
6.5.1.6. 
ADDITIONAL VISIT OR HOSPITALIZATION 
5 
6.5.2. 
EXAMINATIONS THAT ARE NOT COMMON PRACTICES 
6 
6.6. 
DESCRIPTION OF RULES FOR TEMPORARILY OR PERMANENTLY STOPPING THE STUDY 
6 
6.6.1. 
PATIENT DROP OUTS 
6 
6.6.2. 
STUDY TERMINATION BY DECISION OF THE SPONSOR 
6 
6.6.3. 
Center closure 
6 
6.6.4. 
PATIENT FOLLOW-UP PROCEDURES IN THE EVENT OF TERMINATION 
6 
6.7. 
ACCOUNTABILITY PROCEDURES 
7 
6.8. 
MEASURES TO ENSURE IMPARTIALITY OF JUDGEMENT 
7 
7.1. 
INCLUSION CRITERIA 
8 
7.2. 
NON INCLUSION CRITERIA 
8 
7.3. 
Procedure of PREMATURE discontinuation of use of the medical device 
9 

 
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8. 
TREATMENT USED ON THE INDIVIDUALS WHO WILL PARTICIPATE IN THE RESEARCH OTHER THAN THE MEDICAL 
DEVICE TO WHICH THE RESEARCH IS RELATED 
9 
8.1. 
DESCRIPTION OF THE MEDICAL DEVICE USED FOR RESEARCH PURPOSES INCLUDING THE 
IMPLEMENTATION OF THE MEDICAL DEVICE TO WHICH THE RESEARCH RELATE, AS WELL AS THE MONITORING 
PERIOD 9 
8.1.1. 
DEVICE UNDER STUDY : 
9 
8.1.2. 
COMPARATOR : FUSION 
9 
8.2. 
AUTHORIZED AND PROHIBITED  MEDICINES AND TREATMENTS, UNDER THE PROTOCOL, INCLUDING 
EMERGENCY MEDICINES NON APPLICABLE. 
9 
9. 
PERFORMANCE ASSESSMENT 
10 
9.1. 
DESCRIPTION OF EFFICACY ASSESSMENT PARAMETERS 
10 
9.1.1. 
PRIMARY END POINT 
10 
9.1.2. 
SECONDARY ENDPOINTS 
10 
9.2. 
METHODS AND TIMELINE  FOR MEASURING, COLLECTING AND ANALYSING THE PARAMETERS FOR 
ASSESSING EFFECTIVENESS 
11 
9.2.1. 
ODI ( Oswestry disability index) 
11 
9.2.2. 
VAS SCALE TO ASSESS THE PAIN INTENSITY 
11 
9.2.3. 
QUESTIONNAIRE ON THE QUALITY OF LIFE SF12 
11 
9.2.4. 
THE HOSPITAL ANXIETY AND DEPRESSION SCALE. (HAD) 
12 
9.2.5. 
NEUROLOGICAL AND MOTOR STATUS ASSESSMENT 
12 
9.2.6. 
SIMPLE RADIOGRAPHY (TELE RACHIS OR EOS) 
12 
9.2.7. 
DYNAMIC RADIOGRAPHY 
12 
9.2.8. 
MRI 
12 
10. 
SAFETY ASSESSMENT 
13 
10.1. 
DESCRIPTION OF SAFETY ASSESSMENT PARAMETERS 
13 
10.2. 
INTENDED METHODS AND SCHEDULE TO MEASURE, RECORD AND ANALYSE SAFETY ASSESSMENT 
PARAMETERS 
13 
10.3. 
PROCEDURES IN PLACE FOR R FOR ADVERSE EVENT RECORDING AND REPORTING 
13 
10.3.1. 
DEfinition OF ADVERSE EVENTS (AE)/adverse DEVICE events (ADE) 
13 
10.3.2. 
DEfinition OF SERIOUS ADVERSE EVENTS (SAE) 
14 
10.3.3. 
EXPECTED/UNEXPECTED NATURE OF SERIOUS ADVERSE EVENTS 
14 
10.3.3.1. 
EXPECTED Adverse events DUE TO THE DEVICE OR procEdure 
14 
10.3.3.2. 
UNEXPECTED SERIOUS Adverse DEVICE EFFECTS (USADE) 
15 
10.3.4. 
ASSESSMENT OF THE SEVERITY OF AN ADVERSE EVENT AND RELATIONSHIP WITH THE IMPLANTED 
DEVICE 
15 
10.3.5. 
DURATION OF THE PERIOD OF NOTIFICATION OF SAE TO THE SPONSOR 
16 
10.3.6. 
Notification BY the investigator TO THE sponsor 
16 
10.3.7. 
DEclaration BY THE SPONSOR TO THE HEALTH AUTHORITIES 
17 
10.4. 
EMERGING SAFETY ISSUE 
18 
10.4.1. 
DEFINITION OF EMERGING SAFETY ISSUE 
18 
10.4.2. 
DECLARATION BY THE SPONSOR TO THE HEALTH COMPETENT AUTHORITIES 
18 
10.5. 
FOLLOW-UP PROCEDURE AND DURATION FOR PATIENTS AFTER ONSET OF AN ADVERSE EVENT 
18 
10.6. 
MEASURES TO BE TAKEN TO ENSURE SAFETY IN THE CASE OF DEVICE DEFICIENCY, INCLUDING ISOLATED 
MALFUNCTION OF THE DEVICE WITH NO CLINICAL REPERCUSSIONS AND MISUSE 
18 
10.6.1. 
DEFINITION OF FAILURE OF A MEDICAL DEVICE 
18 
10.6.2. 
DECLARATION BY THE SPONSOR TO THE HEALTH COMPETENT AUTHORITIES 
18 
11. 
STATISTICAL ANALYSES 
19 
11.1. 
NUMBER OF SUBJECTS REQUIRED 
19 
11.2. 
DESCRIPTION OF THE STATISTICAL METHODS 
19 
11.2.1. 
STATISTICAL METHODS / STATISTICAL ANALYSES PLAN 
19 
11.2.2. 
DESCRIPTION OF THE POPULATION 
19 
11.2.3. 
FINAL STATISTICAL ANALYSES 
19 

 
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11.2.3.1. 
DESCRIPTION OF THE SUBJECTS FOR THE STUDY, AND VERIFICATION OF THE COMPARABILIITY 
AT INCLUSION 
19 
11.2.3.2. 
ANALYSIS OF THE MAIN CRITERION 
20 
11.2.3.3. 
ANALYSIS OF SECONDARY CRITERIA OF EFFICIENCY 
20 
11.2.3.4. 
ANALYSIS OF THE CLINICAL TOLERANCE 
20 
11.3. 
DEGREE OF STATISTICAL SIGNIFICANCE 
20 
11.4. 
METHODS OF ACCOUNTING FOR MISSING, UNUSED OR INVALID DATA 
21 
11.5. 
MANAGING CHANGES ON THE ANALYSES PLAN 
21 
11.6. 
SELECTION OF INDIVIDUALS TO BE INCLUDED IN THE ANALYSES 
21 
11.6.1. 
INTENT TO TREAT POPULATION (ITT) 
21 
11.6.2. 
PER PROTOCOLE (PP) 
21 
12. 
ACCESS RIGHTS TO THE SOURCE DOCUMENTS AND DATA 
22 
12.1. 
Rights of access to data 
22 
12.2. 
DESCRIPTION OF VARIABLES COLLECTED 
22 
12.2.1. 
OSWERSTY QUESTIONNAIRE 
22 
12.2.2. 
SF 12 QUALITY OF LIFE QUESTIONNAIRE 
22 
12.2.3. 
ASSESSMENT OF THE NEUROLOGICAL AND MOTOR STATUS 
22 
12.2.4. 
VISUAL ANALOGICAL SCALE 
23 
12.2.5. 
THE HOSPITAL ANXIETY AND DEPRESSION SCALE 
23 
12.3. 
IDENTIFICATION OF SOURCE DATA 
23 
13. 
QUALITY CONTROL AND INSURANCE 
24 
13.1. 
RISK MINIMISATION PLAN 
24 
13.2. 
QUALITY INSURANCE PLAN 
24 
13.3. 
MONITORING AND INDICATORS 
25 
14. 
FEASIBILITY AND TIMELINE OF THE STUDY 
26 
15. 
STUDY ORGANIZATION 
27 
15.1. 
STEERING COMMITTEE 
27 
16. 
ETHICAL CONSIDERATIONS 
28 
16.1. 
Declaration stating that THE RESEARCH will be conducted in accordance with the protocol, good 
practice and current legislative and regulatory requirements 
28 
16.2. 
Protection of people 
28 
16.3. 
Insurance 
29 
16.4. 
amendment to the protocol 
29 
16.5. 
BENEFIT/RISK BALANCE 
29 
16.5.1. 
POTENTIAL BENEFITS 
29 
16.5.2. 
POTENTIAL RISKS 
29 
17. 
PROCESSING OF DATA AND STORAGE OF RESEARCH DOCUMENTS AND DATA 
30 
17.1. 
Data circuit 
30 
17.2. 
Methods for processing, verification and validation of data (data management) 
31 
17.2.1. 
DATA MANAGEMENT 
32 
17.2.2. 
BLIND REVIEW AND LOCKING OF THE DATABASE 
32 
17.3. 
Archiving of study documents 
32 
18. 
DATA OWNERSHIP - PUBLICATIONS OF RESULTS 
33 
19. 
BIBLIOGRAPHIC REFERENCES 
34 
20. 
APPENDIX 
36 
20.1. 
STUDY FLOW CHART 
1 
20.2. 
B-DYN DESCRIPTION 
2 
20.3. 
INSTRUCTION FOR USE 
6 
20.4. 
SURGICAL PROCEDURE 
11 
20.5. 
CE MARKED CERTIFICATE 
25 
20.6. 
OSWESTRY DISABILITY INDEX 
28 
20.7. 
SF-12 
29 
20.8. 
Neurological and motor status assessment 
30 

 
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20.9. 
HAD SCALE 
31 
20.10. 
serious adverse event (SAE) recording form 
32 
 

 
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1. 
ABBREVIATIONS – DEFINITIONS 
 
1.1. 
ABBREVIATIONS 
 
CA  
 
Competent Authority 
CRA 
  
Clinical Research Associate 
ASD 
Adjacent Segment Disease 
GCP 
 
Good clinical practice 
PPC 
  
Protection to Persons Committee   
CRF  
 
Case Report Form  
CRO 
  
Contract Research Organisation 
UE 
 
Undesirable Effect/ Side Effect 
SAR 
 
Serious Adverse Reaction 
RRQ  
 
Recording Reguarding the Quality 
Aes 
  
Adverse Event 
SAE 
  
Serious Adverse Event  
ICH E3  
  
International Conference on Harmonization E3 
ICH E6 
  
International Conference on Harmonization E6 
ITT 
 
Intent to Treat 
OR 
 
Odds Ratio 
PP 
 
Per Protocol 
PV 
  
Pharmacovigilance 
LSS 
 
Lumbar Spinal Stenosis  
 
 
1.2. 
DEFINITIONS 
NA. 
 
 
 
 
 

 
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2. 
ADDRESSES AND RESPONSIBILITIES 
2.1. 
PROTOCOL SIGNATORIES 
The signatories attest that the protocol, the CRF and the annexes contain the information and recommendations 
necessary to perform this study. The study will be performed and recorded in accordance with this protocol. All legal 
obligations will be met, as described below. 
The signatories agree to conduct the study in accordance with the requirements of the protocol and of GCP/ICH. All 
changes to the protocol must be approved by the signatories and recorded in writing.  
By signing this protocol, the coordinating investigator agrees to allow all persons delegated by Cousin Biotech 
(auditor, monitors, etc.), or by the Competent Authority (from France or other countries), access to all study data. 
 
 
 
 
 
 
 
 
 
 
 
 
SPONSOR  
COUSIN BIOTECH 
François HENIN, Directeur Général 
Allée des Roses 
59117 Wervicq sud 
 
10/04/2020 
 
 
Date 
Signature 
COORDINATING INVESTIGATOR (France) 
Pr. Vincent POINTILLART 
Service de Chirurgie orthopédique et traumatologique 
Unité de Chirurgie du Rachis 
CHU de Bordeaux – Le Tripode – GH Pellegrin 
Place Amélie Raba-Léon 
33000 BORDEAUX 
10/04/2020 
 
 
Date 
Signature 
COORDINATING INVESTIGATOR (France) 
Dr. Bertrand  DEBONO 
Neurochirurgie - Pôle de Neurosciences 
Clinique des Cèdres - Bat. 2 
31700 Cornebarrieu 
10/04/2020 
 
 
Date 
Signature 
PROJECT DIRECTOR (QUANTA MEDICAL) 
Docteur O. ZOURABICHVILI 
16 Avenue des Châteaupieds 
92500 RUEIL-MALMAISON 
France 
 
10/04/2020 
 
 
 
Date 
Signature 

 
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2.2. 
PROTOCOL SIGNATURE PAGE 
I have read this protocol and certify that I comply with and will observe the confidentiality of all aspects of the study 
requirements defined in this document, in the case report form (CRF) and in the other study documents. 
I have noted the fact that any failure to meet the study requirements by the investigator (myself) or any member of 
the investigating team without discussing this in advance with the sponsor or his/her representative (CRO) will be 
deemed to be a breach of protocol.  
I agree to conduct this study in accordance with current regulations, legislation and other requirements, and more 
specifically:  
 
Law no. 2012-300 of 5 March 2012 on research involving human beings (the so-called Jardé law) modified 
by Order no. 2016-800 of 16 June 2016 and Decree no. 2016-1537 through which this law is applied; 
 
MEDDEV 2.7/3 revision 3 (May 2015) – Guidelines on the reporting of serious adverse events in clinical 
studies on medical devices: 
 
The Decision of 3 March 2017 setting out the form, content and methods for declaring adverse events and 
new findings in research, as described in section 1 of article L. 1121-1 of the French Code of Public Health 
(CSP) on an MD/IVDMD; 
 
The French Code of Public Health; 
 
The Declaration of Helsinki (latest version: October 2013); 
 
Good Clinical Practice (GCP);  
 
ICH (International Conference on Harmonization) recommendations and in particular ICH E6 (Good Clinical 
Practice); 
 
The law relating to data processing, files and freedoms (law n ° 78-17 amended in 2004) 
 
Deliberation no. 2018-153 of 3 May 2018 approving a reference methodology for the processing of 
personal data used in health research with recording of consent from the person concerned (MR-002) and 
rescinding deliberation no. 2016-262 of 21 July 2016; 
 
Law 2018-493 of 20 June 2018 on the protection of personal data;  
 
Standard NF EN ISO 14155 (May 2012) on clinical investigations on medical devices in human subjects. 
 
  
I have duly noted that the study has been granted: 
 
A favourable opinion by the Ethics Committee;   
 
Recording by the Competent Authority.  
By the present signature, I authorise access to the study data concerning the patients involved to Cousin Biotech (or 
to any person duly designated by Cousin Biotech) or to the Competent Authority, etc.). 
 
INVESTIGATOR: 
 
 
  
 
 
NAME:  
 
 
 
Date 
Signature 

 
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3. 
SYNOPSIS 
 
SYNOPSIS 
BDYNCLIN STUDY 
05/03/2020 
 
 
 
 
TITLE 
“Study of the efficacy and tolerance of the B-Dyn medical device 
compared to a conventional bolted fusion with or without cage in the 
treatment of degenerative lumbar stenosis, with or without grade I 
spondylolisthesis on the degree of postoperative functional disability, 
preservation of mobility and prevention of the adjacent syndrome". 
Interventional, prospective, comparative, randomized, non-inferiority, single 
blind, international, multicenter clinical study. 
PROTOCOL NUMBER 
3001_BDYNCLIN 
ID RCB 
 2020-A00553-36 
AUTHORS 
Pr Vincent POINTILLART (CHU Bordeaux), Dr Bertrand DEBONO (Clinique des 
Cèdres),  Dr Othar ZOURABICHVILI (QUANTA MEDICAL), Rym BOULKEDID 
 
 
 
Document approuvé pour diffusion le :  
05/03/2020 
Par : Docteur O. ZOURABICHVILI 
 
Président 
Visa : 
 
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This document contains confidential information belonging to QUANTA MEDICAL. Except as otherwise 
agreed to in writing, by accepting or reviewing this document, you agree to hold this information in 
confidence and not copy or disclose it to others (except where required by applicable law) or use it for 
unauthorized purposes.  In the event of any actual or suspected breach of this obligation, QUANTA MEDICAL 
must be promptly notified. 

 
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SPONSOR 
COUSIN BIOTECH 
MEDICAL DEVICE 
B-Dyn ™ 
DATE AND VERSION  
05/03/2020 – V3-0 
TITLE 
 
 
“Study of the efficacy and tolerance of the B-Dyn medical device compared to a 
conventional bolted fusion with or without cage in the treatment of 
degenerative lumbar stenosis, with or without grade I spondylolisthesis on the 
degree of postoperative functional disability, preservation of mobility and 
prevention of the adjacent syndrome". 
Interventional, prospective, comparative, randomized, non-inferiority, single blind, 
international, multicenter clinical study. 
COORDINATORS  
Pr. Vincent POINTILLART 
Service de Chirurgie orthopédique et traumatologique 
Unité de Chirurgie du Rachis 
CHU de Bordeaux – Le Tripode – GH Pellegrin 
Place Amélie Raba-Léon 
33000 BORDEAUX  
 
Dr Bertrand Debono 
Neurochirurgie - Pôle de Neurosciences 
Clinique des Cèdres - Bat. 2 
31700 Cornebarrieu 
RATIONAL 
The Lumbar Spinal Stenosis: LSS is an extremely common pathology that affects 
more than 102 million people worldwide every year [1]. 
It is most often linked to the combination of a disk space narrowing (loss of height 
and bulging within the canal), a hypertrophy of the yellow ligament and of the joint 
capsules and also a bone overgrowth by the posterior vertebral joints. This may be 
associated with Grade I spondylolisthesis. 
This pathology often extends over several levels, frequently two (L5S1, L4L5 or L4L5, 
L3L4) sometimes more. A relatively homogeneous group of patients falls within the 
group of stenosis, from S1 to L2, without significant deviation (scoliosis or cyphosis 
type). 
A wide variety of different surgical techniques are used to treat patients with LSS 
and patients who have symptoms despite well-conducted medical 
treatment. Decompressive laminectomy may prove to be insufficient when several 
levels are affected and also due to the fears of instability induced by the gesture 
itself (the joint hypertrophy responsible for nerve root compression is also a 
stabilizing element). Therefore, the scientific community usually associates a 
gesture of stabilization with the gesture of decompression. 
The choice of stabilizing means is discussed without any conclusive answer provided 
by any controlled study. This question accounts for the subject of this study. 
Two alternatives are discussed: 
 The current gold standard is to practice rigid stabilization through bolted 
fusion, with or without inter somatic cage, despite the fact that it causes an 
excessive rigidification of the mobile segment, therefore responsible for the 
acceleration of the degeneration of the upper level. 
 Soft stabilization system with pedicular screwing B-Dyn type. It stabilizes the 

 
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arthrodesis while maintaining some mobility. This partial preservation of 
mobility could slow down or prevent the upper level’s degradation. 
Based on the judgment from the dynamic profile images, the devices, some of 
which are approved in the USA claim to favor fusion while providing no information 
on the mobility of the upper level in their studies. 
The aim of this randomized and prospective comparative study would not only be to 
establish the non-inferiority of the procedure under study, versus conventional 
fusion (with or without cage) on the degree of functional disability after surgery, but 
also to demonstrate the significantly higher preservation of the upper level’s 
mobility when assembling. 
 
STUDY PERIOD 
 
First inclusion : May 2020 
 
Inclusion period : 24 months 
 
Last patient’s follow up : May 2027 
 
Analysis and results : November  2027 
 
Phase III 
STUDY OBJECTIVES 
Primary objective: The main objective is to evaluate at 12 months post-operatively 
the effect of the B-Dyn device in the treatment of degenerative lumbar stenosis 
(DLSS), with or without grade I spondylolisthesis compared to classical fusion on the 
degree of post-operative functional disability. 
 
Secondary objective 
1. To evaluate the effect of B-Dyn in the treatment of DLSS compared to a 
Classical screw fusion (with or without cage) between inclusion, 2 months, 
12 months and 60 months post-intervention on the following: 
 
 The mobility of the instrumented level and adjacent levels;  
 The degree of functional disability related to low back pain;         
 The lumbar and radicular pain; 
 The quality of life; 
 The anxiety; 
 The radiological parameters; 
 The neurological and motion status;  
 The walking distance  
2. To evaluate during the study period, the rate of re-operation on the same 
instrumented level or on the adjacent level.   
3. To assess rate of adjacent syndrome (ASD) up to 60 months post 
intervention 
 
4. To assess  side effects reported in both groups. 
 
ENDPOINTS 
PRIMARY ENDPOINT 
The main criterion is the degree of functional disability related to low back pain. It 
will be measured using the Oswestry Disability Index (ODI) at the 12th month 
compared to the baseline data. 
SECONDARY ENDPOINT 

 
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1. the mobility of the instrumented level and adjacent levels will be measured 
at inclusion, 2 months, 12 months and 60 months post intervention using 
dynamic X-rays of the lumbar spine: the degree of mobility is calculated by 
subtracting the angle that is formed in flexure by the tangent of the upper 
layer of the upper vertebra, and the tangent of the lower layer to the angle 
formed by these extending tangents. For double instrumentations, an 
average of the mobility of the two mobile levels is pulled off. 
2. the degree of functional disability related to lumbar and radicular pain will 
be measured by the Oswestry Disability Index (ODI) at inclusion, 2 months, 
12 months and 60 months post-intervention; 
3. the intensity of radicular and lumbar pain will be assessed by the VAS scale 
(0-100) at inclusion, 2 months, 12 months and 60 months post-intervention  
4. the quality of life will be assessed by the SF-12 score at inclusion, 2 months, 
12 months and 60 months post-intervention; 
5. anxiety will be measured using the Hospital Anxiety and Depression Scale 
(HAD) at inclusion, 2 months, 12 months and 60 months post intervention; 
6. radiological parameters such as lumbar lordosis (LL), instrumented level 
segmental lordosis, disk height of the disk above the instrumentation, and 
pelvic parameters (pelvic incidence PI, Sacral slope (Ps) and pelvic tilt (PT) 
will be measured at inclusion, 2 months, 12 months and 60 months post 
intervention using whole body imaging (tele-rachis/ Tele-spine or EOS) 
7. Neurological and motion status will be assessed at the instrumented level 
and adjacent levels (right and left), by measuring motor skills, feeling of 
touch and stinging sensation at inclusion, 2 months, 12 months and 60 
months post-intervention. Various tools will be used: MRC scale (which 
evaluates motor function from 0: no movement/contractions to 5: normal 
muscle strength) ; another scale will be used : from 0 (Absent) to 2 (Normal)  
to evaluate the feeling of touch and sting. 
8. The walking distance will be evaluated by self paced test at inclusion, 2 
months, 12 months and 60 months post-intervention (patient will walk 
maximum possible distance) 
9. The rate of re-intervention on the instrumented level or adjacent level 
during the study (up to 60 months). A re-operation during the study is 
defined as a secondary intervention at the instrumented level or adjacent 
level for any reason (infectious or mechanical): revision, implant removal 
(explantation), fusion, need for additional fixation. etc  
10. If a patient has one (or more) of the following conditions, he/she is 
considered to have an adjacent syndrome during the follow-up until the 
60th month, 
 Adjacent radiological syndrome: observed from simple and 
dynamic radiology and from MRI. It is defined by a narrowing 
of > 3 mm of the disk height, a posterior opening > 5° and 
sliding progression > 3 mm compared to the pre-operative 
data of the lateral bending radiology. On the MRI, it is defined 
by the postoperative progression of disc degeneration 
according to the Pfirrmann classification, as well as the 
progression of spinal canal stenosis evaluated according to 
the classification of Imagama et al [21]. The 1 grade 
progression of disk degeneration or spinal canal stenosis on 

 
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MRI is considered an adjacent radiological syndrome. 
 Adjacent symptomatic syndrome: is diagnosed when clinical 
symptoms such as radicular pain or intermittent claudications 
deteriorate after surgery, and that the lesion responsible for 
the symptoms is the one adjacent to the fused level (on MRI). 
 Surgical Adjacent Syndrome: is defined as an adjacent 
symptomatic syndrome, for which surgery is required to treat 
neurological deterioration at the adjacent degenerative 
segment. 
11. the criteria for assessing safety and tolerance shall be:  
 The number of patients who experienced at least one adverse 
event during the follow-up period. 
 The number of patients who experienced a serious adverse 
event during the follow-up period, 
 The short term and long-term, pre-operative and post-
operative complications rate 
 
METHODOLOGY 
This is a prospective, randomized, multicentric, comparative study of non-inferiority 
in parallel groups with an allocation ratio of 1:1, single-blind (the patient will be 
blinded from the arm of randomization), single blind (The patient will be blinded 
regarding randomization arm). 
The secondary objective of this study will be to assess the performance of the B-Dyn 
device compared to a simple fusion on dynamic parameters and the prevention of 
adjacent syndrome. 
Randomization, with a ratio of 1:1 will be stratified on the center and on the presence 
of spondylolisthesis (spondylolisthesis grade 1 on the highest level VS 
spondylolisthesis grade 1 on the other levels, or no spondylolisthesis at all) 
EXPERIMENTAL  GROUP 
B-Dyn, Medicla device CE Marked    
CONTROL GROUP 
The bolted fusion technique with or without cage 
NUMBER OF PATIENTS 
REQUIRED 
The objective of the project is to look for a non-inferiority of the «B-DYN» group 
compared to the «bolted fusion with or without cage» group, on the degree of 
functional disability after surgery evaluated by the Oswestry disability index (ODI) 
at the 12th month post-surgery. 
According to the literature, patients with a fusion shows 37.1% ODI decrease by 1-
year, compared to the baseline. 
Considering this hypothesis, a sample size of N= 188 patients (94 “Bdyn” / 94 
“Fusion”) will be a 90% demonstration proof of a non-inferiority by considering a 
non-inferiority margin of -2 and a standard deviation of 6.7. Considering a 15% 
attrition rate, we will include a total of 216 patients. An interim analysis is planned 
once 100 patients will have reached the main assessment criterion.  
INCLUSION CRITERIA 
Disease related criteria:  
1. 
Stenosis on 1 or 2 adjacent segments (grade C or D according to Schizas 
classification) on MRI 
2. 
Spondylolisthesis grade 1 or no spondylolisthesis 
3. 
Pseudoclaudication  (Pseudoclamping) on one or both legs and back pain 
(VAS score> 30) 

 
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4. 
Patient who has failed well-managed medical treatment that has not  
resulted in long-lasting symptom relief (duration of symptoms > 6 
months);  
5. 
Patient with no contraindication to fusion or the application of B-Dyn®. 
Population-related criteria 
1. 
Subject: both sexes, 40 years of age and older 
2. 
Patient who has given free, informed and written consent to participate in 
the study; 
3. 
Patient who is able to respond to questionnaires and who can 
communicate in the language of the study country ; 
4. 
Patient affiliated to a social security scheme or entitled to a social security 
scheme. 
NON INCLUSION 
CRITERIA 
Disease related criteria: 
1. 
Spondylolisthesis of grade > 1 
2. 
Degenerative Scoliosis (Cobb angle > 20°); 
3. 
History of fusion for spinal stenosis or vertebral instability 
4. 
Stenosis not caused by from degenerative changes.  
5. 
Isolated disc herniation 
6. 
Other specific vertebral damage (for example: ankylosing spondylitis, 
cancer or neurological disorders) 
7. 
History of vertebral fractures resulting from the compression at the 
instrumented level  
8. 
History of osteoporotic fractures 
9. 
Psychological disorders (e.g. dementia or substance abuse) that lead to an 
inability to participate in the study  
10. Intervention required on more than 3 vertebral levels; 
11. Chronic infection 
 
Population related criteria: 
1. 
Withdrawal of consent; 
2. 
Pregnancy; 
3. 
Breastfeeding woman; 
4. 
Participation in a clinical trial in the 3 months prior to the initial visit; 
5. 
Drug addiction; 
6. 
Predicted unavailability during study. Patient deprived of liberty or under 
guardianship. 
Medical Device related criteria: 
1. 
Allergy to any of the components of the medical device. 
 
STUDY DESIGN 
Patient assessments will be carried out in the following stages: 
Visit 1 : Inclusion  
1. Inform the patient and collect his/her informed consent form; 
2. Perform a general clinical test; 
3. Collect the medical history, the associated pathologies and the surgical 
history;  
4. Note all concomitant treatments; 
5. Collect the data base on CRF and will complete or make sure to have the 
following questionnaires completed: 
 Questionnaire to calculate the Oswestry Disability Index ; 
 SF-12 ; 
 Motion and sensitivity assessment ; 
 Assessment of lumbar and radicular pain through the VAS 

 
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 Assessment of the anxiety through the HAD questionnaire 
 Assessment of the walking distance  
6. Perform an intraoperative lumbar spine MRI for compression 
objectification and specify the Modic stage 
7. Whole Body Imaging (Tele-rachis or EOS) to assess radiological parameters 
such as Lumbar Lordosis (LL), Instrumented Level Segmental Lordosis (LS), 
… etc  
8. An X-ray examination - dynamic images of the lumbar in flexion/extension 
and its lateral angulation 
9. Verify the inclusion and non-inclusion criteria (to be verified when of all the 
results are collected); 
10. Set the date of intervention 
11. The investigator will proceed – immediately or during consultation – to 
random draw in order to pick the intervention. Therefore, the investigator 
will log on to Quanta View®, in order to obtain the randomization results.  
 
 
 
Visit 2: INTERVENTION AND POST-OPERATIVE FOLLOW-UP 
1. Collect the concomitant treatments; 
2. Collect the operative data : 
 Surgery date ; 
 Duration of the intervention ; 
 Installation of the device ; 
 Adverse events: complications linked to surgery and 
complications linked to the installation of the implant (for 
example, insufficient distance between the screws) 
3. Collect the immediate post-operative data: 
 Duration of stay at the hospital; 
 Pain (VAS) on the post-operative day; 
4. Collect the tolerance data and search for adverse events; 
5. Complete the CRF for the visit that corresponds; 
6. Plan the next visit. 
 
 
 
 
Visit 3 – 2ND MONTH POST-SURGERY (± 7 DAYS),   
1. A clinical test ; 
2. Collect the concomitant treatments ; 
3. Collect of the intercurrents effects (AEs/SAE) ; 
4. Whole-body imaging (Tele-rachis or EOS) to evaluate radiological 
parameters such as lumbar lordosis (LL), segmental lordosis of instrumented 
level (LS), etc. etc 
5. Radiographic examination of dynamic lumbar images, in flexion/extension 
and in lateral inclination; this helps to measure the mobility and the search 
for the material mobilization in relation to the vertebrae (lysis chamber). If 
such mobilization exists, a scanner will be performed to confirm it. 
6. CRF data collection and completion (or make sure to complete) of various 
questionnaires: 
 SF-12 ; 
 Questionnaire to calculate the Oswestry Disability Index; 
 Motion and sensitivity assessment 

 
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 Assessment of the lumbar and radicular pain through the VAS 
 HAD Questionnaire for anxiety; 
 Walking distance  
7. Collect of surgical re- operations (date, ground, etc.) ; 
 
 
Visit 4 – 12TH MONTH (D365± 30 DAYS),   
1. A clinical test ; 
2. collect concomitant treatmentss ; 
3. Collect intercurrents effects (AEs/SAE) ; 
4. Whole-body imaging (Tele-rachis or EOS) to evaluate radiological 
parameters such as lumbar lordosis (LL), segmental lordosis of instrumented 
level (LS), etc. etc 
5. Radiographic examination of dynamic lumbar images, in flexion/extension 
and in lateral inclination; this helps to measure the mobility and the search 
for the material mobilization in relation to the vertebrae (lysis chamber). If 
such mobilization exists, a scanner will be performed to confirm it. 
6. An MRI 
7. CRF data collection and completion (or make sure to complete) of various 
questionnaires: 
 SF-12 ; 
 Questionnaire to calculate the Oswestry Disability Index; 
 Motion and sensitivity assessment 
 Assessment of the lumbar and radicular pain through the VAS 
 HAD Questionnaire for anxiety; 
 Walking distance  
   
8. Collect of surgical re-operations (date, ground, etc.) ; 
 
 
Visit 5 – 60TH MONTH (D365± 30 DAYS),   
1. A clinical test ; 
2. collect concomitant treatments ; 
3. Collect intercurrents effects (AEs/SAE); 
4. Whole-body imaging (Tele-rachis or EOS) to evaluate radiological 
parameters such as lumbar lordosis (LL), segmental lordosis of 
instrumented level (LS), etc.  
5. Radiographic examination of dynamic lumbar images, in flexion/extension 
and in lateral inclination; this helps to measure the mobility and the search 
for the material mobilization in relation to the vertebrae (lysis chamber). If 
such mobilization exists, a scanner will be performed to confirm it. 
6. An MRI 
7. CRF data collection and completion (or make sure to complete) of various 
questionnaires: 
 SF-12 ; 
 Questionnaire to calculate the Oswestry Disability Index; 
 Motion and sensitivity assessment 
 Assessment of the lumbar and radicular pain through the VAS 
 HAD Questionnaire for anxiety; 
 Walking distance  
 
8. CRF data collection and completion (or make sure to complete) of various 
questionnaires: 

 
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9. Collect of surgical re- operations (date, ground, etc.) ; 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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4. 
SCIENTIFIC JUSTIFICATION AND GENERAL DESCRIPTION OF THE 
RESEARCH  
4.1. 
NAME AND DESCRIPTION OF THE MEDICAL DEVICE TO WHICH THE RESEARCH RELATES  
B-Dyn® medical device is a dynamic posterior stabilization system used for the treatment of disc degeneration 
and/or joint facets, spinal stenosis, grade I spondylolisthesis and segmental hyper-mobility. 
The Bdyn spine cushioning with Sterile Posterior Dynamic Stabilization - Bdyn is composed of a hollow metal 
cylindrical body containing elastomeric silicone and urethane polycarbonate components that are implantable in the 
long run, and are deformed by a metal piston rod connected to the vertebra of the treated segment by pedicular 
polyaxials Bdyn screws. The elastomeric components ensure the absorption of the mechanical stresses exerted on 
the intervertebral joint that are in compression, in traction, in flexion-extension, and in lateral flexion. Some 
configurations allow the fixation of several intervertebral levels. 
 
The B-Dyn device components as well as their properties are represented in the Figure 1.  
The combination of rigid and flexible parts allows to preserve mobility and absorb the bending loads, the traction 
and the compression.  
The B-Dyn product range is available in four different models: 
 
The references of the different models of the B Dyn device are listed in Appendix 20.2 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mobile rod 
Fixed rod 
Cylindrical 
cover
Cushion made of 
silicone elastomer
Ring made of 
PU elastomer

 
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The device’s detailed description is provided in the instruction manual and in the description of the surgical technique 
(cf. appendices 20.3 and 20.4) 
A dynamic level 
A dynamic level and one (or two)  
maximum fusion level 

 
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The B Dyn device belongs to Class IIB. It obtained the CE marking in 2008. The CE conformity assessment was carried 
out by SGS (see Appendices 20.5). It is used worldwide. 
In addition to preserving the mobility of the treated segments, the surgeons appreciate in one hand, the speed of 
the intervention, and on the other hand, the compatibility of the device with the fusion, which allows them to to 
choose the best suited system for the patient, during the surgery (this decision is made once the screws are placed, 
the doctor can choose between fusion or B-Dyn®). 
4.2. 
DESCRIPTION AND JUSTIFICATION OF THE USE OF THE MEDICAL DEVICE AND THE 
TREATMENT TIME  
The Bdyn spine cushioning with Sterile Posterior Dynamic Stabilization- Bdyn is intended for posterior stabilization 
of the thoracic vertebra T10 at the sacrum S1, with or without bone graft for the following: 
 Degeneration of the intervertebral disc and/or joint facets, confirmed by further tests. 
 Stenosis of the lumbar canal 
 Grade 1 degenerative spondylolisthesis 
 Segmental hypermobility 
The Bdyn device must be implanted exclusively by a qualified surgeon. The latter needs to have the knowledge of the 
use of the product as well as the knowledge of anatomy, spine surgery, the technique of attaching the pedicular 
screws and the specific surgical technique of installing the Bdyn device. 
 
4.3. 
DETAILED DESCRIPTION OF THE USE OF THE DEVICE TO WHICH THE RESEARCH RELATES AND 
OF THE SURGICAL PROCEDURES  
The surgical technique for the installation of the B-Dyn device is detailed in Appendix 20.3 and 20.4. 
Surgery is performed under general anesthesia.  
The procedure begins with the installation of the first upper polyaxial screw using a polyaxial screwdriver. In order 
to position the second screw, it is necessary to use the phantom (Trial 10). Once the screws are positioned, the B-
Dyn is caught between the jaws of the grip detection, so it can be inserted into the head of the polyaxial screws. The 
B-Dyn’s mobile rod is then placed into the top screw head. The fixed rod’s positioning must be placed facing the 
operator, and it has to be into the center of the lower screw head. 
 The B-DYN grip detection has to be held first, and then, the clamp adjustment is inserted in order to adjust the inter-
pedicular distance of the B-DYN. Finally, the cap of the lower polyaxial pedicular screw is tightened. 
A final tightening of the two screw caps on the polyaxial pedicular screws is made for maximum security. 
 
 
 
 

 
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4.4. 
SCIENTIFIC JUSTIFICATION OF THE RESEARCH 
Degenerative lumbar stenosis (Lumbar Spinal Stenosis: LSS) is an extremely common disease affecting more than 102 
million people worldwide every year [1]. 
It is one of the most common indications for spinal surgery [2, 3]. 
It is the result a degenerative cascade combining a disc pinch (loss of height and bulging in the vertebral canal), a 
hypertrophy of the ligaments and joint capsules, and a bone hypertrophy in the posterior joints processes. In addition 
to these stenotic elements, there may be some malalignment of the vertebrae as they may shift from one another 
(spondylolisthesis grade I), or there may even occur some deformations such as the scoliosis or degenerative cyphosis 
type. This pathology often develops on a number of levels, frequently two (L5S1, L4L5 or L4L5, L3L4), and sometimes 
even more. These elements cause a narrowing of the canal containing the spinal nerves, they also cause invertebral 
foramen allowing the nerves to exit the canal. The clinical symptomatology of this nosological set combines spinal 
pain and root pain with possibly neurological claudication, degrading patients' quality of life [4]. 
The therapeutic approach often requires surgery, in cases in which the well-conducted medical treatment remains 
unsuccessful [5]. Quite a few surgical techniques are used to treat patients with LSS, still, there is much controversy 
about this multifaceted syndrome [6]. 
The elementary surgical step (laminectomy) is intended to decompress the contents of the degenerative canal, but 
it may be insufficient when several levels are affected, and because the means of union between the vertebrae have 
been sacrificed, this may cause additional instability induced by the gesture itself [5, 7]. This instability can in turn 
cause painful symptoms of the lower back and/or or of the joints, and impaired neurological signs [8, 9]. 
Therefore, it has been suggested by many authors to associate a gesture of stabilization with the gesture of 
decompression [10]. 
The choice of stabilization means is discussed without any controlled study providing a conclusive response [11–14]. 
This question is the subject of this study. 
Two alternatives were discussed: 
 Rigid stabilisations by bolted fusion, with or without inter somatic cage (intersomatic 
arthrodesis), are the current standard gold, although they are blamed for excessive 
rigidification of the mobile segment responsible for the acceleration of the degeneration of 
the upper level (Adjacent Segment Disease: ASD) [8]. 
 Flexible stabilization systems with dynamic rod and pedicular screwing (for example, type B-
Dyn, Dynesys ). This allows to stabilize the segment(s) operated while keeping some mobility 
of the anatomical region. This partial preservation of mobility could slow or prevent the 
degradation of the upper level [15]  
As a matter of fact, the ongoing degeneration of the adjacent segments relative to a lumbar vertebral fusion is a 
concern for surgeons, and a source of symptoms for patients. This degeneration of the upper level represents a 
significant percentage of the spinal revision surgery [16]. Literature tells us that radiographic degeneration of the 
adjacent segment is very common after lumbar spinal fusion (5-45% of cases), but a smaller proportion of this 
evolution causes clinically significant symptoms, or requires revision surgery (2-15%) [17]. These revision procedures 
(neurological decompression on the incriminated level, cephalic and/or caudal extension of the assembly) require 
surgical procedures that can be complex, and may imply significant morbidity risks to patients [18]. 
Several types of dynamic stabilization devices have been developed to reduce mechanical stress on the adjacent 
segment. All of them claim the quality of the fusion, however, there are controversies about whether or not, 
such devices can reduce the ASD [19]. The current state of the art does not allow any conclusion. 

 
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The ideal procedure would therefore be to combine a dynamic stabilization with the first step of 
decompression; this dynamic stabilization provides the patient with the clinical benefits of a fusion without 
degrading the upper level [20]. 
Therefore, it seems relevant to be able to provide reliable data on (i) the 12th-month clinical results of this type 
of implants, when it comes to pain control and quality of life improvement, and also, data on (ii) the radiological 
parameters showing the preservation of the mobility of the upper level which reflects the protective effect of 
this dynamic system. The study will be extended by a 60th-month assessment to assess the presence of an 
adjacent clinical and radiological syndrome. 
The objective of this randomized, prospective comparative study would be to establish the non-inferiority of 
the studied device versus conventional fusion (with or without cage) on the degree of functional incapacity 
after surgery, but also to demonstrate the preservation of the mobility of the upper level when assembled. 
 
 

 
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5. 
OBJECTIVES OF THE STUDY   
 
5.1. 
MAIN OBJECTIVE 
The main objective is to evaluate at 12 months post-operatively the effect of the B-Dyn device in the treatment of 
degenerative lumbar stenosis (DLSS), with or without grade I spondylolisthesis compared to classical fusion on the 
degree of post-operative functional disability.. 
 
5.2. 
SECONDARY OBJECTIVES 
1. To evaluate the effect of B-Dyn in the treatment of DLSS compared to a Classical screw fusion (with or 
without cage) between inclusion, 2 months, 12 months and 60 months post-intervention on the following: 
 
 The mobility of the instrumented level and adjacent levels;  
 The degree of functional disability related to low back pain;                             
 The lumbar and radicular pain; 
 The quality of life; 
 The anxiety; 
 The radiological parameters; 
 The neurological and motion status;  
 The walking distance  
2. To evaluate during the study period, the rate of re-operation on the same instrumented level or on the 
adjacent level.   
3. To assess rate of adjacent syndrome (ASD) up to 60 months post intervention 
 
4. To assess side effects reported in both groups. 
 
 
 
 
 

 
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6. 
STUDY DESIN  
6.1. 
EVALUATION CRITERIA 
6.1.1. 
PRIMARY ENDPOINT 
The main criterion is the degree of functional disability related to low back pain. It will be measured using the 
Oswestry Disability Index (ODI) at the 12th month compared to the baseline data. 
 
6.1.2. 
SECONDARY ENDPOINTS 
1. the mobility of the instrumented level and adjacent levels will be measured at inclusion, 2 months, 12 months 
and 60 months post intervention using dynamic X-rays of the lumbar spine: the degree of mobility is 
calculated by subtracting the angle that is formed in flexure by the tangent of the upper layer of the upper 
vertebra, and the tangent of the lower layer to the angle formed by these extending tangents. For double 
instrumentations, an average of the mobility of the two mobile levels is pulled off. 
2. the degree of functional disability related to lumbar and radicular pain will be measured by the Oswestry 
Disability Index (ODI) at inclusion, 2 months, 12 months and 60 months post-intervention; 
3. the intensity of radicular and lumbar pain will be assessed by the VAS scale (0-100) at inclusion, 2 months, 12 
months and 60 months post-intervention  
4. the quality of life will be assessed by the SF-12 score at inclusion, 2 months, 12 months and 60 months post-
intervention; 
5. anxiety will be measured using the Hospital Anxiety and Depression Scale (HAD) at inclusion, 2 months, 12 
months and 60 months post intervention; 
6. radiological parameters such as lumbar lordosis (LL), instrumented level segmental lordosis, disk height of 
the disk above the instrumentation, and pelvic parameters (pelvic incidence PI, Sacral slope (Ps) and pelvic 
tilt (PT) will be measured at inclusion, 2 months, 12 months and 60 months post intervention using whole 
body imaging (tele-rachis/ Tele-spine or EOS) 
7. Neurological and motion status will be assessed at the instrumented level and adjacent levels (right and 
left), by measuring motor skills, feeling of touch and stinging sensation at inclusion, 2 months, 12 months 
and 60 months post-intervention. Various tools will be used: MRC scale (which evaluates motor function 
from 0: no movement/contractions to 5: normal muscle strength) ; another scale will be used : from 0 
(Absent) to 2 (Normal)  to evaluate the feeling of touch and sting. 
8. The walking distance will be evaluated by self paced test at inclusion, 2 months, 12 months and 60 months 
post-intervention (patient will walk maximum possible distance) 
9. The rate of re-intervention on the instrumented level or adjacent level during the study (up to 60 months). 
A re-operation during the study is defined as a secondary intervention at the instrumented level or adjacent 
level for any reason (infectious or mechanical): revision, implant removal (explantation), fusion, and need 
for additional fixation. etc  
10. If a patient has one (or more) of the following conditions, he/she is considered to have an adjacent syndrome 
during the follow-up until the 60th month, 
 Adjacent radiological syndrome: observed from simple and dynamic radiology and from MRI. 
It is defined by a narrowing of > 3 mm of the disk height, a posterior opening > 5° and sliding 
progression > 3 mm compared to the pre-operative data of the lateral bending radiology. On 
the MRI, it is defined by the postoperative progression of disc degeneration according to the 

 
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Pfirrmann classification, as well as the progression of spinal canal stenosis evaluated 
according to the classification of Imagama et al [21]. The 1 grade progression of disk 
degeneration or spinal canal stenosis on MRI is considered an adjacent radiological 
syndrome. 
 Adjacent symptomatic syndrome: is diagnosed when clinical symptoms such as radicular 
pain or intermittent claudications deteriorate after surgery, and that the lesion responsible 
for the symptoms is the one adjacent to the fused level (on MRI). 
 Surgical Adjacent Syndrome: is defined as an adjacent symptomatic syndrome, for which 
surgery is required to treat neurological deterioration at the adjacent degenerative segment. 
11. the criteria for assessing safety and tolerance shall be:  
 The number of patients who experienced at least one adverse event during the follow-up 
period. 
 The number of patients who experienced a serious adverse event during the follow-up 
period, 
 The short term and long-term, pre-operative and post-operative complications rate 
 
6.2. 
RESEARCH METHODOLOGY  
6.2.1. 
STUDY DESIGN AND FLOW CHART 
This is a prospective, randomized, multicenter, comparative study of non-inferiority in parallel groups with an 
allocation ratio of 1:1, single-blind (the patient will be blinded from the arm of randomization). 
The duration of patient follow-up is 60 months. The inclusion period is 24 months in order to recruit the number of 
subjects needed for the study. 
When the patient is eligible, he is randomized. After each procedure, the follow-up is scheduled over 60 months, 
with 3 consultation visits scheduled after surgery: in the 2nd, 12th and 60th months, with collection and 
measurement of the criteria for evaluation. 
The V1 Inclusion Visit will confirm the indication; the inclusion and non-inclusion criteria will be assessed; the patient 
will have the opportunity to sign the consent. The random draw is also done during this visit (before the surgery). 
The Visit V2 corresponds to the procedure. The Visit V3 happens at the 2nd month following the surgery. The Visit 
V3 on the 12th month will help assess the main judgement criterion, and the one that happens on the 60th month 
(V5) as the study closes 
In case of hospitalization or consultation that occurs outside the original schedule, additional visits will be planned

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Visits 
V1 
Inclusion  
V2  
intra- & 
post-op 
V3 
Follow up 
V4 
Follow up 
V5 
Follow up 
Additional visits 
       
Data to be collected or 
Tests to be done  
 
D0 
M2 
(± 7 d) 
M12 
(± 30 d) 
M60 
(± 60 d) 
Consultation or hospitalisation 
Information and signature of the consent  
 ✔ 
  
  
  
  
  
Medical history 
✔ 
  
  
  
  
  
History of the disease  
✔ 
  
  
  
  
  
Inclusion / non-inclusion criteria  
✔ 
  
  
  
  
  
Clinical test 
✔ 
✔ 
✔ 
✔ 
✔ 
✔ 
Randomization and allocation of intervention 
 ✔ 
  
  
  
  
  
Intra-post-op. Immediat data collection  
  
✔ 
  
  
  
  
Case Report Form (CRF) 
✔ 
✔ 
✔ 
✔ 
✔ 
✔ 
Oswestry Disability Index 
✔ 
  
✔ 
✔ 
✔ (sup) 
✔ 
Quality of life questionnaire (SF-12) 
 ✔ (sup) 
  
✔ (sup) 
✔ (sup) 
✔ (sup) 
  
Motion and sensitivity assessment 
✔ 
 
✔ 
✔ 
✔ (sup) 
 
VAS (low back pain and radicular pain) 
✔ 
✔ 
✔ 
✔ 
✔ (sup) 
  
Anxiety (HAD score) 
✔ (sup) 
  
✔ (sup) 
✔ (sup) 
✔ (sup) 
 
Walking distance 
✔ 
 
✔ 
✔ 
✔ (sup) 
 
MRI  
✔ 
  
  
 ✔ (sup) 
✔ (sup) 
  
Radiography (Télé-rachis or EOS)  
✔ 
  
✔  
✔  
✔ (sup) 
  
Dynamic Radiograph  
✔ 
 
✔ 
✔ 
✔ (sup) 
✔ 
AE (Adverse event)  collection 
  
✔ 
✔ 
✔ 
✔ 
✔ 
Collect of concomitant treatments 
  
✔ 
✔ 
✔ 
✔ 
✔ 
Supp : Additional tests compared to common practices 
Days 

 
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6.2.2. 
PARTICIPATION SITES 
The research will be carried out in the following countries: France, Belgium, Georgia, with 20  participating centers. 
Each center will have to recruit an average of 12 to 18 patients. 
The centers were selected according to the following criteria: 
 Ability to recruit patients according to protocol; 
 Sufficient availability to conduct the study; 
 Ability to obtain high quality data in accordance with protocol requirements; 
 Adherence to regulatory requirements (BPC, etc.), legal requirements and other 
requirements that are specific to the study. 
In addition, investigators must meet the following criteria: 
 Have recognized experience in surgical treatment of degenerative lumbar stenosis and rod 
placement. 
 
6.3. 
MEASURES TAKEN TO REDUCE AND AVOID BIAS 
6.3.1. 
RANDOMIZATION 
This is a randomized study. The randomization list will be generated using SAS® 9.4 software. Once the eligibility 
criteria have been verified and once the consent have been obtained, the patient will be randomized by the 
computer. Randomization, with a ratio of 1:1 will be stratified on the center and on the presence of spondylolisthesis 
(spondylolisthesis grade 1 on the highest level VS spondylolisthesis grade 1 on the other levels, or no 
spondylolisthesis at all). Randomization is performed in blocks of random sizes. It will be performed via the electronic 
application QUANTA VIEW®. 
During each randomization, electronic information will be sent to the member of the study team responsible for 
monitoring inclusion rates. This information will include the patient’s initials, the date of inclusion, the inclusion 
number for the study, and the identification of the physician who included the patient.  
6.3.2. 
BLINDING 
The patient will be blinded to randomization arm. Since the procedure is performed under general anesthesia, the 
patient will not be informed whether or not the B-Dyn® device has been installed during the procedure. The 
assessment of the main judgement criterion (the ODI being a patient reported outcome) will therefore be blind to 
the group of randomization. Other secondary criteria such as quality of life or pain intensity will also be evaluated 
blindly in regards to the group of randomization (assessment by patient). The blind process cannot be applied to the 
surgeon. The installation of the device cannot be hidden from him or her. 
A centralized reading of all radiographs (Tele-rachis or dynamic images) will be performed by an independent 
radiologist. 
The assessment criteria such as the re- operations are objective criteria, and they can be assessed without bias even 
if the monitor has some knowledge of the group randomization. 

 
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6.3.3. 
BLIND REVIEW 
The data review will be carried out at the end of the study to judge deviations. It will be done by the steering 
committee, blind to the group of randomization.  
6.4. 
MODALITIES FOR USING THE DEVICES ON WHICH THE RESEARCH IS RELATED AND THE SURGICAL 
PROCEDURES INVOLVED IN THE IMPLEMENTATION OF THE DEVICE IN THE RESEARCH 
6.4.1. 
THE B-DYN® DEVICE 
All the investigators performing this implant must be surgeons who has a broad experience in the installation of 
surgical treatment devices for degenerative lumbar stenosis. 
The contents of the devices used for the research are aseptically-packaged. The implantation instruments, supplied 
separately for B-DYN are not sterile and must be sterilized beforehand (See details in appendix 20.2). 
The B-DYN® device is described in paragraph 4.1. The surgical installation technique is developed in the attached 
manual (Appendix 20.5). 
 The procedure is performed under general anesthesia. 
6.4.2. 
THE BOLTED FUSION TECHNIQUE WITH OR WITHOUT CAGE 
The fusion, also called lumbar arthrodesis consists of blocking the painful level(s), in order to limit the movement of 
the affected disc. In just few months, this assembly results in the fusion (or welding) of the affected vertebrae, and 
therefore decreases the pain. The surgeon will complete his gesture by placing 2 screws in the upper vertebra and 2 
screws in the lower vertebra; the screws will be connected to each other to stabilize the assembly. This type of 
surgery is done via posterior approach. 
6.5. 
PROCESS AND DURATION OF INDIVIDUALS PARTICIPATION 
6.5.1. 
PROCESS FOR A PATIENT 
6.5.1.1. VISITS V1 – INCLUSION VISIT 
During the visit, the investigator will: 
1. Inform the patient and collect his/her informed consent form; 
2. Perform a general clinical test; 
3. Collect the medical history, the associated pathologies and the surgical history;  
4. Note all concomitant treatments; 
5. Collect the data base on CRF and will complete or make sure to have the following questionnaires 
completed: 
 Questionnaire to calculate the Oswestry Disability Index ; 
 SF-12 ; 
 Motion and sensitivity assessment ; 
 Assessment of lumbar and radicular pain through the VAS 
 Assessment of the anxiety through the HAD questionnaire 
 Assessment of the walking distance  
6. Perform an intraoperative lumbar spine MRI for compression objectification and specify the Modic stage 
7. Whole Body Imaging (Tele-rachis or EOS) to assess radiological parameters such as Lumbar Lordosis (LL), 
Instrumented Level Segmental Lordosis (LS), … etc  
8. An X-ray examination - dynamic images of the lumbar in flexion/extension and its lateral angulation 

 
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9. Verify the inclusion and non-inclusion criteria (to be verified when of all the results are collected); 
10. Set the date of intervention 
11. The investigator will proceed – immediately or during consultation – to random draw in order to pick the 
intervention. Therefore, the investigator will log on to Quanta View®, in order to obtain the randomization 
results.  
 
After reviewing that the eligibility criteria are met, that the patient is absolutely clear in terms of the consent he/she 
is giving, the investigator will proceed - immediately or during the consultation - to the random draw in order to pick 
the intervention. Therefore, the investigator will log on to QUANTA VIEW® to retrieve randomization results. The 
patient will then be assigned an anonymity number (this will later reported as the patient identifier). 
The patients will belong to either one of the following : 
1. The « B-Dyn» arm; 
2. The Fusion arm : with or without a cage 
 
6.5.1.2. VISIT V2 – INTERVENTION AND POST-OPERATIVE FOLLOW-UP 
During the intervention, the investigator will:  
1. Collect the concomitant treatments; 
2. Collect the operative data : 
 Surgery date ; 
 Duration of the intervention ; 
 Installation of the device ; 
 Adverse events: complications linked to surgery and complications linked to the installation 
of the implant (for example, insufficient distance between the screws) 
3. Collect the immediate post-operative data: 
 Duration of stay at the hospital; 
 Pain (VAS) on the post-operative day; 
4. Collect the tolerance data and search for adverse events; 
5. Complete the CRF for the visit that corresponds; 
6. Plan the next visit. 
 
6.5.1.3. VISIT V3 –2ND MONTH POST-SURGERY (± 7 DAYS),   
This visit occurs on the 2nd month post-surgery. It will include : 
1. A clinical test ; 
2. Collect the concomitant treatments ; 
3. Collect of the intercurrents effects (AEs/SAE) ; 
4. Whole-body imaging (Tele-rachis or EOS) to evaluate radiological parameters such as lumbar lordosis (LL), 
segmental lordosis of instrumented level (LS), etc. etc 
5. Radiographic examination of dynamic lumbar images, in flexion/extension and in lateral inclination; this helps 
to measure the mobility and the search for the material mobilization in relation to the vertebrae (lysis 
chamber). If such mobilization exists, a scanner will be performed to confirm it. 
6. CRF data collection and completion (or make sure to complete) of various questionnaires: 
 SF-12 ; 
 Questionnaire to calculate the Oswestry Disability Index; 
 Motion and sensitivity assessment 
 Assessment of the lumbar and radicular pain through the VAS 
 HAD Questionnaire for anxiety; 
 Walking distance  
7. Collect of surgical re- operations (date, ground, etc.) ; 

 
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6.5.1.4. VISIT V4 – 12TH MONTH (D365± 30 DAYS),   
The visit will occur on the 12th month, D365 ± 30 days. It will include : 
1. A clinical test ; 
2. collect concomitant treatmentss ; 
3. Collect intercurrents effects (AEs/SAE) ; 
4. Whole-body imaging (Tele-rachis or EOS) to evaluate radiological parameters such as lumbar lordosis (LL), 
segmental lordosis of instrumented level (LS), etc. etc 
5. Radiographic examination of dynamic lumbar images, in flexion/extension and in lateral inclination; this helps 
to measure the mobility and the search for the material mobilization in relation to the vertebrae (lysis 
chamber). If such mobilization exists, a scanner will be performed to confirm it. 
6. An MRI 
7. CRF data collection and completion (or make sure to complete) of various questionnaires: 
 SF-12 ; 
 Questionnaire to calculate the Oswestry Disability Index; 
 Motion and sensitivity assessment 
 Assessment of the lumbar and radicular pain through the VAS 
 HAD Questionnaire for anxiety; 
 Walking distance  
8. Collect of surgical re-operations (date, ground, etc.) ; 
 
6.5.1.5. VISIT V5 – 60TH MONTH (D365± 30 DAYS),   
The visit will occur on the 60th month, D1825 ± 30 days. It will include:  
1. A clinical test ; 
2. collect concomitant treatments ; 
3. Collect intercurrents effects (AEs/SAE); 
4. Whole-body imaging (Tele-rachis or EOS) to evaluate radiological parameters such as lumbar lordosis (LL), 
segmental lordosis of instrumented level (LS), etc.  
5. Radiographic examination of dynamic lumbar images, in flexion/extension and in lateral inclination; this 
helps to measure the mobility and the search for the material mobilization in relation to the vertebrae (lysis 
chamber). If such mobilization exists, a scanner will be performed to confirm it. 
6. An MRI 
7. CRF data collection and completion (or make sure to complete) of various questionnaires: 
 SF-12 ; 
 Questionnaire to calculate the Oswestry Disability Index; 
 Motion and sensitivity assessment 
 Assessment of the lumbar and radicular pain through the VAS 
 HAD Questionnaire for anxiety; 
 Walking distance  
 
8. CRF data collection and completion (or make sure to complete) of various questionnaires: 
9. Collect of surgical re- operations (date, ground, etc.) ; 
 
6.5.1.6.  ADDITIONAL VISIT OR HOSPITALIZATION 
In the case of an unplanned visit or in the case of hospitalization, a visit will be planned. 
 
 

 
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6.5.2. 
EXAMINATIONS THAT ARE NOT COMMON PRACTICES 
 
Patients are usually consulted by the 2nd and 12th month post-surgery. The tests performed during these visits are 
the common tests: x-rays, MRI … etc. The questionnaires to assess the quality of Life, the ODI, the Neurological and 
Motor Status are also performed during the patient’s usual care. The MRI costs for the 12th month visit will be 
covered by the sponsor as part of this research. 
The 60th-month visit is added to the usual patient care. The costs of the 60th month visit tests (MRI, X-rays, travel 
expenses) will be borne by the sponsor as part of this research. 
 
6.6. 
DESCRIPTION OF RULES FOR TEMPORARILY OR PERMANENTLY STOPPING THE STUDY 
6.6.1. 
PATIENT DROP OUTS  
The patient may withdraw from the study at any time on the decision of the investigator or on the patient’s own 
decision because of: 
 Withdrawal of consent; 
 Inability to continue the protocol; 
 Explantation of the device ; 
 Etc. 
Regardless of the reason for premature withdrawal, the investigator must complete the end of study assessment in 
the CRF.  The main reason for study withdrawal will be documented in the source file and in the CRF. 
For patients lost to follow-up, the investigator must indicate in the source file the reason for study withdrawal (loss 
to follow-up) and indicate details of reminder telephone calls/letters to the patient asking him to return for the final 
evaluation visit.  
 
6.6.2. 
STUDY TERMINATION BY DECISION OF THE SPONSOR  
There are no specific rules governing discontinuation of the study by the sponsor. The latter thus reserves the right 
to terminate the study at any time. If the sponsor terminates the biomedical study early or suspends it temporarily, 
the investigator will be informed immediately of the reason for such termination or suspension closure of a study 
centre. 
 
6.6.3. 
CENTER CLOSURE 
An investigating centre may be closed:  
 
On the decision of the sponsor in the event of: 
 Lack of inclusions within 3 months after the study set-up date; 
 Non-compliance with GCP/ICH in conducting the study. 
 
On the decision of the investigator. In this case, the investigator will inform the sponsor as soon as 
possible and explain the reasons for discontinuing the study in detail in writing.  
 
 
6.6.4. 
PATIENT FOLLOW-UP PROCEDURES IN THE EVENT OF TERMINATION   
If the devices are explanted or the patient withdraws his/her consent, his/her clinical follow-up is continued outside 
of the protocol according to the patient’s usual management until the end of the follow-up period stipulated in the 

 
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study.  The same applies if the study is stopped.  If the B-DYN is explanted the patient may be offered implantation 
of an alternative device such as  intersomatic cages… etc or a fusion 
Patients will continue to be followed-up in their original department regardless of the reasons for discontinuation of 
the study. 
 
6.7. 
ACCOUNTABILITY PROCEDURES 
The devices will be packaged by the Sponsor, in compliance with legal and regulatory requirements and Good 
Manufacturing Practice requirements.  
Each label will carry the following information:    
 The name, postal address + telephone no. of the manufacturer (i.e., the sponsor); 
 The product reference codes; 
 The bar code enabling product traceability; 
 The list of the medical device components; 
 The batch no.;  
 The end of use date;  
 The special storage conditions;  
 The word “sterile”;  
 The warnings and precautions to be taken. 
 
The following details will be added to the original label but will not obscure the wording already printed on the 
initial packaging: 
 Name of the coordinating investigator; 
 Postal address and telephone number of the coordinating investigator; 
 The ID RCB number; 
 The wording “For biomedical research only”; 
 a free text field entry to enter the patient identification number.  
The B-DYN devices are previously labelled by the sponsor. These are listed in a follow-up file (follow-up application 
in QUANTA VIEW®) allowing monitoring of the devices implanted in patients, the devices available in each centre and 
the real time supply of the centres. 
The medical devices will be stored in a place dedicated for this purpose or in the hospital pharmacy.     
The medical devices for this study may not be used for an alternative use other than that defined in the protocol. 
The investigator or centre staff are not, under any circumstances, authorised to provide the products to another 
investigator or another centre or use them for an alternative purpose.  
 
6.8. 
MEASURES TO ENSURE IMPARTIALITY OF JUDGEMENT  
The methods used to guarantee blinding with regard to the primary end point are described in section Erreur ! Source 
du renvoi introuvable.. The methods used to guarantee impartiality of judgement concerning deviations are listed 
in the blind data review (cf. section Erreur ! Source du renvoi introuvable.).  
 
 

 
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7. 
SELECTION AND EXCLUSION OF THE PARTICIPANTS FOR THE RESEARCH  
 
7.1. 
INCLUSION CRITERIA 
Disease related criteria:  
1. 
Stenosis on 1 or 2 adjacent segments (grade C or D according to Schizas classification) on MRI 
2. 
Spondylolisthesis grade 1 or no spondylolisthesis 
3. 
Pseudoclaudication  (Pseudoclamping) on one or both legs and back pain (VAS score> 30) 
4. 
Patient who has failed well-managed medical treatment that has not  resulted in long-lasting symptom relief 
(duration of symptoms > 6 months);  
5. 
Patient with no contraindication to fusion or the application of B-Dyn®. 
Population-related criteria 
1. 
Subject: both sexes, 40 years of age and older 
2. 
Patient who has given free, informed and written consent to participate in the study; 
3. 
Patient who is able to respond to questionnaires and who can communicate in the language of the study 
country ; 
Patient affiliated to a social security scheme or entitled to a social security scheme. 
 
7.2. 
NON INCLUSION CRITERIA   
Disease related criteria: 
1. 
Spondylolisthesis of grade > 1 
2. 
Degenerative Scoliosis (Cobb angle > 20°); 
3. 
History of fusion for spinal stenosis or vertebral instability 
4. 
Stenosis not caused by from degenerative changes.  
5. 
Isolated disc herniation 
6. 
Other specific vertebral damage (for example: ankylosing spondylitis, cancer or neurological disorders) 
7. 
History of vertebral fractures resulting from the compression at the instrumented level  
8. 
History of osteoporotic fractures 
9. 
Psychological disorders (e.g. dementia or substance abuse) that lead to an inability to participate in the study  
10. Intervention required on more than 3 vertebral levels; 
11. Chronic infection 
Population related criteria: 
1. 
Withdrawal of consent; 
2. 
Pregnancy; 
3. 
Breastfeeding woman; 
4. 
Participation in a clinical trial in the 3 months prior to the initial visit; 
5. 
Drug addiction; 
6. 
Predicted unavailability during study. Patient deprived of liberty or under guardianship. 
Medical Device related criteria: 
1. 
Allergy to any of the components of the medical device. 

 
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7.3. 
PROCEDURE OF PREMATURE DISCONTINUATION OF USE OF THE MEDICAL DEVICE 
There is no procedure for early discontinuation of use per se.  The decision to explant or replace the device is a 
decision made by the surgeon as a result of a complication or malfunction.  The surgeon may take the decision as to 
the opportunity to use this measure, the methods used and follow-up to be instituted.  
 
8. 
TREATMENT USED ON THE INDIVIDUALS WHO WILL PARTICIPATE IN THE 
RESEARCH OTHER THAN THE MEDICAL DEVICE TO WHICH THE RESEARCH 
IS RELATED 
8.1. 
DESCRIPTION OF THE MEDICAL DEVICE USED FOR RESEARCH PURPOSES INCLUDING THE 
IMPLEMENTATION OF THE MEDICAL DEVICE TO WHICH THE RESEARCH RELATE, AS WELL AS THE 
MONITORING PERIOD 
8.1.1. 
DEVICE UNDER STUDY :  
The B-Dyn ® device is described in the paragraph 4.1 
You can also refer to appendices 20.3 and 20.4 
8.1.2. 
COMPARATOR : FUSION 
The bolted fusion, with or without cage is described in the paragraph 6.4.2 
 
8.2. 
AUTHORIZED AND PROHIBITED  MEDICINES AND TREATMENTS, UNDER THE PROTOCOL, INCLUDING 
EMERGENCY MEDICINES NON APPLICABLE. 
NOT APPLICABLE 

 
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9. 
PERFORMANCE ASSESSMENT 
9.1. 
DESCRIPTION OF EFFICACY ASSESSMENT PARAMETERS  
9.1.1. 
PRIMARY END POINT  
The main criterion is the degree of functional disability related to low back pain. It will be measured using the 
Oswestry Disability Index (ODI) at the 12th month compared to the baseline data. 
 
9.1.2. 
SECONDARY ENDPOINTS 
1. the mobility of the instrumented level and adjacent levels will be measured at inclusion, 2 months, 12 months 
and 60 months post intervention using dynamic X-rays of the lumbar spine: the degree of mobility is 
calculated by subtracting the angle that is formed in flexure by the tangent of the upper layer of the upper 
vertebra, and the tangent of the lower layer to the angle formed by these extending tangents. For double 
instrumentations, an average of the mobility of the two mobile levels is pulled off. 
2. the degree of functional disability related to lumbar and radicular pain will be measured by the Oswestry 
Disability Index (ODI) at inclusion, 2 months, 12 months and 60 months post-intervention; 
3. the intensity of radicular and lumbar pain will be assessed by the VAS scale (0-100) at inclusion, 2 months, 12 
months and 60 months post-intervention  
4. the quality of life will be assessed by the SF-12 score at inclusion, 2 months, 12 months and 60 months post-
intervention; 
5. anxiety will be measured using the Hospital Anxiety and Depression Scale (HAD) at inclusion, 2 months, 12 
months and 60 months post intervention; 
6. radiological parameters such as lumbar lordosis (LL), instrumented level segmental lordosis, disk height of 
the disk above the instrumentation, and pelvic parameters (pelvic incidence PI, Sacral slope (Ps) and pelvic 
tilt (PT) will be measured at inclusion, 2 months, 12 months and 60 months post intervention using whole 
body imaging (tele-rachis/ Tele-spine or EOS) 
7. Neurological and motion status will be assessed at the instrumented level and adjacent levels (right and left), 
by measuring motor skills, feeling of touch and stinging sensation at inclusion, 2 months, 12 months and 60 
months post-intervention. Various tools will be used: MRC scale (which evaluates motor function from 0: no 
movement/contractions to 5: normal muscle strength); another scale will be used: from 0 (Absent) to 2 
(Normal) to evaluate the feeling of touch and sting. 
8. The walking distance will be evaluated by self-paced test at inclusion, 2 months, 12 months and 60 months 
post-intervention (patient will walk maximum possible distance) 
9. The rate of re-intervention on the instrumented level or adjacent level during the study (up to 60 months). A 
re-operation during the study is defined as a secondary intervention at the instrumented level or adjacent 
level for any reason (infectious or mechanical): revision, implant removal (explantation), fusion, and need for 
additional fixation. etc  
10. If a patient has one (or more) of the following conditions, he/she is considered to have an adjacent syndrome 
during the follow-up until the 60th month, 

 
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 Adjacent radiological syndrome: observed from simple and dynamic radiology and from MRI. 
It is defined by a narrowing of > 3 mm of the disk height, a posterior opening > 5° and sliding 
progression > 3 mm compared to the pre-operative data of the lateral bending radiology. On 
the MRI, it is defined by the postoperative progression of disc degeneration according to the 
Pfirrmann classification, as well as the progression of spinal canal stenosis evaluated 
according to the classification of Imagama et al [21]. The 1 grade progression of disk 
degeneration or spinal canal stenosis on MRI is considered an adjacent radiological 
syndrome. 
 Adjacent symptomatic syndrome: is diagnosed when clinical symptoms such as radicular 
pain or intermittent claudications deteriorate after surgery, and that the lesion responsible 
for the symptoms is the one adjacent to the fused level (on MRI). 
 Surgical Adjacent Syndrome: is defined as an adjacent symptomatic syndrome, for which 
surgery is required to treat neurological deterioration at the adjacent degenerative segment. 
 
 
9.2. 
METHODS AND TIMELINE FOR MEASURING, COLLECTING AND ANALYSING THE PARAMETERS FOR 
ASSESSING EFFECTIVENESS 
The data collection calendar to assess effectiveness is provided in the general outline (cf. the general outline in 
paragraph 6.2.1). 
The various measurement tools and questionnaires used in this trial are listed below: 
9.2.1. 
ODI ( OSWESTRY DISABILITY INDEX) 
The Oswestry questionnaire helps assess the symptoms and severity of back pain, as well as the impairment on daily 
life activities. The questionnaire contains 10 questions, concerning: pain, personal care, loads, walking ability, sitting 
position, standing position, sleep, sexual life, social life, travels. Each question offers 6 answers, with a score of 0 to 
6 that the patient must choose; score 0 corresponds to a normal function, and score 6 to a very diminished function. 
(CF appendix 20.3). 
The score obtained is multiplied by 2 to get a percentage of disability, with 0% for the absence of disability, and 100% 
for the most important disability. Completion of the test takes about 5 minutes 
The Oswestry Disability Index will be measured at inclusion, 2nd month, 12th month and 60th month post-surgery. 
9.2.2. 
VAS SCALE TO ASSESS THE PAIN INTENSITY  
The visual analogue scale is shaped as a graduated ruler: from 0 to 100; 0 means that the subject has no pain and 
100 is the maximum pain he can bear. It’s a self-assessment scale. It is sensitive, reproducible, reliable and validated 
in both acute and chronic pain situations. 
The intensity of the lumbar and radicular pain will be measured at inclusion on the first post-operative day, at the 
2nd month, 12th month and 60th month post-surgery. 
9.2.3. 
QUESTIONNAIRE ON THE QUALITY OF LIFE SF12  
The SF-12 test is an abridged version of the « Medical Outcomes Study Short-Form General Health Survey »(SF-36) 
with only 12 of the 36 questions. The SF 12 generates two scores: a mental and social quality of life score and a 
physical quality of life score. The quality of life will be measured at inclusion, at the 2nd month, at the 12th month 
and at the 60th month post-surgery. (See Appendix 20.7).  

 
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9.2.4. 
THE HOSPITAL ANXIETY AND DEPRESSION SCALE. (HAD) 
The HAD scale is a tool that detects anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. There 
are seven questions related to anxiety (total A) and seven others related to the depressive dimension (total D); this 
provides two scores (maximum score of each score = 21). (cf. appendix 20.9) 
The depression and anxiety score will be measured at inclusion on the first post-operative day, at the 2nd month, 
the 12th month, and the 60th month post-surgery. 
9.2.5. 
NEUROLOGICAL AND MOTOR STATUS ASSESSMENT 
Different tools will be used: an MRC scale (which evaluates the motor function: 0 means no movement/contractions, 
5 means normal muscle strength), and another scale: 0 means Absent and 2 means Normal ; this is used to assess 
the sensation of touch and sting. The neurological and motor status will be assessed at the L4, L5 and S1 levels (right 
and left) (See Appendix 20.8) 
9.2.6. 
SIMPLE RADIOGRAPHY (TELE RACHIS OR EOS)  
This is a face and profil X-ray, on which the sagittal alignment parameters will be measured. It will be carried out at 
the 2nd month, the 12th month, and the 60th month post intervention. 
An independent radiologist will be in charge of the centralized reading. 
9.2.7. 
DYNAMIC RADIOGRAPHY  
This is an radiograph, on which the mobility of the instrumented level and the adjacent levels will be measured. 
During this radiograph, the patient will be asked to bend down until he/she reaches the painful threshold in flexion 
and extension, and in lateral inclination. This image should focus on the instrumented level. 
It will be carried out at the 2nd month, the 12th month, and the 60th month post intervention.  
An independent radiologist will be in charge of the centralized reading. 
9.2.8. 
MRI 
This is an examination to confirm a stenosis and an adjacent syndrome. It will be performed at the 12th month , and 
the 60th month. 
 
 
 
 
 
 
 
 

 
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10. 
SAFETY ASSESSMENT 
10.1. 
DESCRIPTION OF SAFETY ASSESSMENT PARAMETERS 
The criteria for assessing safety and tolerance shall be:  
 The number of patients who experienced at least one adverse event during the follow-up 
period. 
 The number of patients who experienced a serious adverse event during the follow-up 
period, 
 The short term and long-term, pre-operative and post-operative complications rate 
 
10.2. 
INTENDED METHODS AND SCHEDULE TO MEASURE, RECORD AND ANALYSE SAFETY ASSESSMENT 
PARAMETERS 
The schedule for data collection enabling assessment of safety is shown in study design section (Cf. Plan of the study 
in section Erreur ! Source du renvoi introuvable..). 
 
10.3. 
PROCEDURES IN PLACE FOR R FOR ADVERSE EVENT RECORDING AND REPORTING  
10.3.1. DEFINITION OF ADVERSE EVENTS (AE)/ADVERSE DEVICE EVENTS (ADE)  
Adverse event (AE): any untoward or unfavorable medical occurrence in a human beings undergoing research 
involving human subject, whether or not considered related to the subject’s participation in the research. 
Adverse device effect (ADE): any untoward and unintended responses to the use of an investigational medical device. 
This includes any adverse event resulting from insufficiencies or inadequacies in the instructions for use, the 
deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical 
device - This includes any event that is a result of a use error or intentional misuse. 
Each AE must be classified by the investigator as serious or non-serious. This classification determines the procedure 
to be followed in reporting the event to the Sponsor Cousin Biotech.  
This definition includes events related to both the investigational device and the comparator. It also includes events 
relating to implantation of the device. 
The investigator must record all AEs observed directly and all AEs reported by the patient using suitable medical 
terminology. During visits, patient will be questioned by the investigator about the onset of any AEs throughout the 
entire study. 
Adverse events are recorded in the case report form. The investigator must indicate any possible relationship 
between the investigational device and the adverse event, as well as the relationship between implantation of the 
device and the adverse event. 
The safety evaluation criteria must be evaluated and recorded by the investigators throughout the study, and 
collected by the Sponsor during monitoring visits. These comprise symptoms, dates, outcome, measures taken, and, 
where necessary, the results of any examinations and laboratory tests. 
The investigator must record in the “adverse events” section of the case report form any events significant for the 
study: 
 
1. Reported by the patient (spontaneously or during the questioning) or observed by the investigator 
(during clinical examination); 
2. Whether or not they are considered attributable to the device or to the surgery process; 
3. the record of the event will comprise the following information:  

 
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 Type of event (brief description in objective rather than interpretive terms); 
 Date of onset and date of resolution of the adverse event (where applicable); 
 Seriousness of the event (i.e. serious or not serious); 
 Outcome of the event (resolution with or without sequelae); 
 Measures taken regarding the implant (removal, replacement, adjustment); 
 Causal relationship with the investigational device (unlikely, possible, probable, certain); 
 Causal relationship with implantation of the device (unlikely, possible, probable, certain). 
Patients may contact the investigator about any adverse events occurring during the study or after the end of the 
study.  
Defects in the device in terms of its identity, quality, durability, reliability, safety or its performances must be 
recorded throughout the entire duration of the study. Such deficiencies will be reported at least as adverse events. 
 
10.3.2. DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
Any adverse event which: 
1. Results in death (including deaths due to progression of the disease being treated);  
2. Places the life of the person involved in the research in danger (i.e., immediately life-threatening at the 
time of the adverse event independently of the consequences of corrective or palliative treatment); 
3. Requires hospitalisation or prolongs hospitalisation; 
4. Causes incapacity (any clinically significant, temporary or permanent handicap) or severe or 
sustainable handicap; 
5. Results in a congenital abnormality or malformation.  
 
Planned hospitalisation for a pre-existing disorder or a procedure required by the protocol without serious 
deterioration in health is not deemed to be a serious adverse event. 
Other events which do not meet the criteria listed above may be deemed to be “potentially serious”.  These events 
may be declared in the same way as per the declaration of serious adverse events on the medical judgement of the 
investigator or COUSIN BIOTECH. 
 
10.3.3. EXPECTED/UNEXPECTED NATURE OF SERIOUS ADVERSE EVENTS  
10.3.3.1. EXPECTED ADVERSE EVENTS DUE TO THE DEVICE OR PROCEDURE 
The expected complications are as follows: 
1. All of the possible adverse events associated with spinal surgery and without instrumentation are 
possible:  
 Infection  
 Pseudomeningocele, fistula, breach dura, persistent CSF leakage, meningitis  
 Loss of neurological function, sensorial and/or motor, including complete or incomplete 
paralysis, dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, 
and/or the development or continuation of pain, numbness, neuroma, spasms, sensory loss, 
tingling sensation, and/or visual deficits  
 Cauda equina syndrome, neuropathy, transient or permanent neurological deficits, 
paraplegia, paraparesis, reflex deficits, irritation, arachnoïditis, and/or muscle loss  
 Urinary retention or loss of bladder control or other types of urological system compromise  
  Scar formation possibly causing by a neurological compromise or compression around nerves 
and/or pain  
 Fracture, microfracture, resorption, damage or penetration of any spinal bone (including the 
sacrum, pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, 

 
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above and/or below the level of surgery  
 Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of 
surgery, canal adjacent stenosis  
  Non-union or pseudarthrosis, delayed union. Mal union  
 Cessation of any potential growth of the operated portion of the spine  
  Loss of or increase in spinal mobility or function  
  Inability to perform the activities of daily living  
 Bone loss or decrease in bone density  
 Graft donor site complications including pain, fracture, or wound healing problems  
 Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal 
system compromise  
 Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, 
excessive bleeding, phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, 
or other types of cardiovascular system compromise  
 Reproduction system compromise, sterility, sexual dysfunction  
 Development of respiratory problems, e.g. pulmonary embolism, atelectasis, bronchitis, 
pneumonia, etc  
 Change in mental status 
  Death 
 
2. All of the possible adverse events associated with spinal surgery with instrumentation are possible. A 
listing of potential adverse events linked to the medical device includes, not limited to:  
 Early or late loosening of any or all of the components  
 Disassembly, bending and/or breakage of any or all of the components (screw breakage)  
 Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, 
and/or general corrosion), including metallosis, tumor formation and/or autoimmune disease  
 Pressure on the skin from components parts with inadequate tissue coverage over the 
implant possibly causing skin penetration, irritation, fibrosis, neurosis, and/or pain  
 Tissue or nerve damage caused by improper positioning and placement of implants or 
instruments  
 Post-operative change in spinal curvature, loss of correction, height, and/or reduction 
 
10.3.3.2. UNEXPECTED SERIOUS ADVERSE DEVICE EFFECTS (USADE)  
A serious adverse effect, the type, severity, outcome or complications of which are inconsistent with known 
information or information appearing in the instructions for use leaflet (Cf. annexe Erreur ! Source du renvoi 
introuvable.) when it carries the CE mark and in the protocol or investigator’s brochure when it does not carry the 
CE mark. 
 
10.3.4. ASSESSMENT OF THE SEVERITY OF AN ADVERSE EVENT AND RELATIONSHIP WITH THE IMPLANTED DEVICE 
The investigator will assess the severity of the adverse event as follows in the case report form: 
 
MILD  
Not restricting everyday activities  
MODERATE  
Resulting in partial restriction of everyday activities  
INTENSITY 
Causing an inability to carry out everyday activities  
The seriousness and intensity of an adverse event must be distinguished.  Severity is a measurement of intensity 
and a severe reaction is therefore not necessarily a serious reaction.  The investigator must also assess the causal 

 
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relationship between the adverse event and the implantation of the device based on the information available and 
using the following criteria: 
 
UNRELATED 
There is no chronological relationship between implantation of the device and the 
event. Thus, either the cause of the event has been identified or the investigational 
device cannot be implicated. 
RELATIONSHIP 
UNLIKELY 
The time to onset of the event is relatively inconsistent with the implantation of the 
device; other possible causes exist. 
RELATIONSHIP 
POSSIBLE 
A chronological relationship exists, but other causes appear more likely; however, the 
implantation of the device cannot be ruled out. 
RELATIONSHIP 
PROBABLE 
A chronological relationship exists, and while other causes are possible, they are 
unlikely. 
 
10.3.5.  DURATION OF THE PERIOD OF NOTIFICATION OF SAE TO THE SPONSOR 
 
The collection period for AEs and SAEs will begin as soon as informed consent has been signed and end at the 24 
month visit. 
This period, however, may be extended if the investigator considers that it is necessary to follow-up the event for a 
longer period of time or for an unresolved SAEs.  
All adverse events, whether or not related to the implanted device, must be followed-up until they have resolved or 
until the investigator considers them to be chronic or stable or until the patients’ participation in the study has ended 
(i.e., a final report has been produced for this patient). In addition, all serious and non-serious adverse events which 
are deemed by the investigator to be potentially related to the study device or to the procedure used for the device 
must be followed-up, even after the end of the study. 
The instructions to report changes in ongoing adverse events during the patient’s participation in the study are shown 
in the corresponding pages of the case report form. 
All events which occur in patients during this period must be reported to COUSIN BIOTECH by the investigator as 
soon as he/she becomes aware of them and whether or not they are deemed to be related to the device. 
Any event which occurs after the end of the study and which the investigator assesses as being potentially related to 
the research must also be reported as an adverse event. 
 
10.3.6. NOTIFICATION BY THE INVESTIGATOR TO THE SPONSOR 
The investigator must notify to the sponsor: 
Any SAEs, whether or not related to the medical device or procedure used, and whether expected or unexpected in 
nature, without delay from the day on which he/she becomes aware of it. 
Serious adverse events will be recorded in the “Adverse event” section of the eCRF. The investigator will complete 
and approve the SAE notification form in the eCRF. 
He/she will, wherever possible, submit all documents which may be of use to the sponsor (all hospitalisation 
reports/letters/anonymised investigation results explaining the circumstances of the SAE, its treatment and its 
outcome.  Notifications will be made automatically via the eCRF to the COUSIN BIOTECH Head of Regulatory Affairs: 
Franck Pelletier 
E-mail: f.pelletier@cousin-biotech.com 
 

 
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If information is missing from the initial notification form this must be followed by a “follow-on” notification (using a 
new SAE notification form) within five calendar days following the discovery of the SAE.  
If necessary, the investigator can notify an SAE using a paper form. 
On receipt of the SAEs form, it will be examined by a senior member of the sponsor’s device’s vigilance who will:  
1. Assess whether the SAE was expected or unexpected; 
2. Assess the causal relationship between the SAE and the medical device or implantation of the device; 
3. Contact the Study Coordinator, the notifying department, to obtain information about the 
circumstances of onset of the SAE and about the treatment and outcome of the event. 
Any SAE for which a relationship with the investigational medicinal device has not been completely excluded will be 
declared to ANSM by the sponsor. 
The incidence of expected SAEs will be monitored by the sponsor’s SAEs committee.  If the incidence of an expected 
SAEs increases this will be redefined as unexpected and a new declaration will be made to ANSM. 
NOTE: If the investigator is not immediately aware of an SAEs, he/she must report this within 24 hours of becoming 
aware of it, explaining how he/she became aware of it. 
 
10.3.7. DECLARATION BY THE SPONSOR TO THE HEALTH AUTHORITIES  
For any events occurring during this research and liable to be related to the medical device and for any SAE related 
to the procedure used for the device, after becoming aware of this SAE the sponsor will make a declaration by e-mail 
to ANSM at: EC.DM-COS@ansm.sante.fr 
1. Without delay for SAE which resulted in death, was life-threatening or associated with an imminent 
risk of death or for a serious injury or disease which justified prompt curative treatment or any new 
information relating to this;  
2. Immediately and within 7 days for the other SAE 
If an initial declaration of an SAE is incomplete, as soon as the further information has been received the sponsor will 
submit a reference numbered follow-on report for this SAE to ANSM. 
Annually following the anniversary date of the inclusion of the first patient into the study and throughout the 
duration of the study, on request the sponsor will submit to ANSM and to the EC a safety report taking account of all 
available safety information.  This report will include, among other things, a list of all suspected serious adverse 
events and an analysis of safety information concerning people taking part in the research.  
If no expected or unexpected SAE is declared in this study, only an annual electronic e-mail will be sent to ANSM and 
to the EC to inform them that no SAE has occurred.  The development and declaration of expected and unexpected 
SAE will be checked routinely in the monitoring visits. 
A summary of the final report will be submitted to ANSM and to the EC within a period of one year following the end 
of the research. 
 
 

 
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10.4. 
EMERGING SAFETY ISSUE 
10.4.1. DEFINITION OF EMERGING SAFETY ISSUE 
This refers to any new information which may result in:  
1. A reassessment of the benefit/risk balance of the research or on the medical device on which the 
research is being carried out; 
2. Changes : 
 To the use of the medical device;  
 To the conduct of the research; 
 To documents relating to the research. 
3. Suspension, interruption or a change to the research protocol.  
 
10.4.2. DECLARATION BY THE SPONSOR TO THE HEALTH COMPETENT AUTHORITIES  
The Sponsor must inform competent Authorities of any emerging safety issue and, where applicable, any measures 
taken. An emerging safety issue may also correspond to an unexpected serious adverse device effect or an SAE 
potentially associated with implantation of the MD. In this case, a double declaration must be made of the event in 
question. Follow-up procedure and duration for patients after onset of an adverse event 
 
10.5. 
FOLLOW-UP PROCEDURE AND DURATION FOR PATIENTS AFTER ONSET OF AN ADVERSE EVENT 
Any person presenting an adverse effect/event (whether serious or not) will receive follow-up appropriate to their 
condition and will be monitored until the event has resolved or until the end of the research. If necessary, use of the 
medical device may be suspended. who develops an adverse effect/event (serious or non-serious) will receive 
appropriate management for his/her condition and be followed-up until the event has resolved or until the end of 
the research.  If necessary, the use of the medical device may be interrupted.  
 
10.6. 
MEASURES TO BE TAKEN TO ENSURE SAFETY IN THE CASE OF DEVICE DEFICIENCY, INCLUDING ISOLATED 
MALFUNCTION OF THE DEVICE WITH NO CLINICAL REPERCUSSIONS AND MISUSE 
10.6.1. DEFINITION OF FAILURE OF A MEDICAL DEVICE  
Inadequacy of the investigational medical device relating to its identity, quality, lifespan, reliability, safety or 
performance.  Defects include malfunctions, usage errors or inadequate information provided by the manufacturer. 
 
10.6.2. DECLARATION BY THE SPONSOR TO THE HEALTH COMPETENT AUTHORITIES  
After becoming aware of the failure the sponsor will submit an immediate declaration after 7 days by e-mail to ANSM 
at: EC.DM-COS@ansm.sante.fr, pour  
1. Any failure of the investigational medical device which may have resulted in a serious adverse event if:  
a) Appropriate action was not taken or;  
b) A procedure was not conducted or; 
c)  If the circumstances had been less “random”.   
 
 
 

 
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11. 
STATISTICAL ANALYSES  
11.1. 
NUMBER OF SUBJECTS REQUIRED 
The objective of the project is to look for a non-inferiority of the «B-DYN» group compared to the «bolted fusion with 
or without cage» group, on the degree of functional disability after surgery evaluated by the Oswestry disability index 
(ODI) at the 12th month post-surgery. 
According to the literature, patients with a fusion shows 37.1% ODI decrease by 1-year, compared to the baseline. 
Considering this hypothesis, a sample size of N= 188 patients (94 “Bdyn” / 94 “Fusion”) will be a 90% demonstration 
proof of a non-inferiority by considering a non-inferiority margin of -2 and a standard deviation of 6.7. Considering a 
15% attrition rate, we will include a total of 216 patients. An intermediate analysis is planned once 100 patients will 
have reached the main assessment criterion.  
11.2. 
DESCRIPTION OF THE STATISTICAL METHODS  
This is a randomized, single-blind, comparative study. 
All analyses will be described and detailed in the statistical analysis plan, and will be drawn up by the statistician in 
charge of the study, and validated before the database is frozen. 
The analysis plan will be reviewed by the statistical and clinical team, when the data are complete and available, and 
before the unblinding at the Blind review meeting. During the review, decisions will be made on the appropriate 
course of action to be taken, in relation to contentious cases (including false data), this will also be detailed in the 
final statistical analysis plan. This document will be placed in the test file prior to the unblinding.  
11.2.1. STATISTICAL METHODS / STATISTICAL ANALYSES PLAN 
All analyses will be performed with the SAS® version 9.4 or the later version. 
All analyses will be described and detailed in the statistical analysis plan. This document will be blindly written and 
validated before the Blind review. Any changes made to this document after the Blind review will be subject to an 
amendment to the statistical analysis plan. The last validated version of the Statistical Analysis Plan prior to 
unblinding will be considered as the final version of this document. 
11.2.2. DESCRIPTION OF THE POPULATION 
Demographic and initial characteristics will be described for both treatment groups. 
The previous and concomitant treatments will be coded by ATC, code from the WHODRUG medical dictionary. 
The medical history and the associated pathology will be coded by the MEdDRA® medical dictionary. 
 
11.2.3. FINAL STATISTICAL ANALYSES  
11.2.3.1. DESCRIPTION OF THE SUBJECTS FOR THE STUDY, AND VERIFICATION OF THE COMPARABILIITY AT 
INCLUSION 
A comparative analysis will be carried out on the patient population, which can be evaluated for tolerance, for all the 
documented characteristics: initial data and evaluation criteria. 

 
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For the quantitative criteria, the initial and final values, and the variation will be described by average, by standard 
deviation or by median (quartiles), depending on the distribution (normal or not) of the data, with minimum and 
maximum, and with 95% CI if applicable. For qualitative criteria: percentages and 95% CI will be calculated. 
The characteristics of inclusion will be described for each group. As the study is randomized, no statistical tests will 
be used to compare patient’s characteristics at inclusion. 
11.2.3.2. ANALYSIS OF THE MAIN CRITERION  
Each time 100 patients meet the main criteria of evaluation, the analysis will be conducted with intent to treat each 
of them.  This analysis will use a triangular test. 
The analysis of the main judgement criterion will consist of comparing the Oswestry Disability Index (ODI) between 
the "B-DYN" group and the "Bolted Fusion with or without cage" group at M12, adjusted to the base score value by 
a covariance analysis (ANCOVA). A random effect at the center level will be introduced. 
11.2.3.3. ANALYSIS OF SECONDARY CRITERIA OF EFFICIENCY 
Analysis of the B-DYN effect on the evolution of the Oswestry disability index, the lumbar and radicular pain VAS 
score, the quality of life score, anxiety, and the range of radiological parameters (mobility, etc.), between the 
inclusion, M2 and M12, and M60. The motor and neurological status scores will also be assessed in a mixed ANCOVA 
model for repeated measurements.  
In case of a non-compliance with the validity conditions of the test, a transformation of variables can be applied. If 
this method shows to be insufficient, a rank analysis will be implemented. A random effect at the center level will be 
introduced into the model. For all these tests, the bilateral significance threshold is set at 5%. 
The comparison of the relapse rate and surgical re-operations (explantations, revisions and re-operations whatever 
the cause) between the two groups will be done using a Chi2 or Fisher test in case of insufficient numbers. 
11.2.3.4. ANALYSIS OF THE CLINICAL TOLERANCE  
The occurrence of these events (revision, explantation) will be described by using the Kaplan-Meier method, and it 
will be compared between the two groups by the log-rank test. 
The incidence rates of adverse events will be calculated and compared between the groups using Chi² or Fisher in 
case of insufficient numbers. 
The intensity of adverse events will be compared between the groups using Chi² or Fisher in case of insufficient 
numbers. 
The incidence of Aes will be tabulated by preferred system and/or organ, and by the term defined by the MedDra 
classification. 
A particular attention will be paid to patients who have had at least one severe adverse event with severe intensity, 
causing the explantation of the tested device; or if the severe adverse event is judged in relation to the treatment 
being tested (possible, severe or certain). 
The analysis of adverse events will be conducted through a “patient” approach rather than an “event” approach. 
For all these tests, the bilateral significance threshold is set at 5%. 
11.3. 
DEGREE OF STATISTICAL SIGNIFICANCE  
Cf. the paragraph 11.2.3 

 
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11.4. 
METHODS OF ACCOUNTING FOR MISSING, UNUSED OR INVALID DATA      
Data quality control is programmed to detect missing and inconsistent data. All missing data will be searched in the 
source folder. If the missing data cannot be retrieved by the CRA (Clinical Research Associate) of the study, a multiple 
imputation procedure may be considered based on the number of missing data and the underlying mechanism. 
11.5. 
MANAGING CHANGES ON THE ANALYSES PLAN  
The statistical analysis plan will be written blind with respect to the data. If changes must be done to the methods 
described in the « Statistical Analysis » paragraph of this protocol, they will be validated by the referent statistician 
in the Statistical Analysis Plan. 
11.6. 
SELECTION OF INDIVIDUALS TO BE INCLUDED IN THE ANALYSES     
11.6.1. INTENT TO TREAT POPULATION (ITT) 
All randomized patients who received any of the interventions. This population coincides with the population of 
patients assessed for tolerance. 
All the patients that have given consent, and have been randomized will be analyzed according to their group of 
randomization. 
For tolerance analyses, in case of randomization errors (device set up), patients will be analyzed according to the 
procedure they have received. 
11.6.2. PER PROTOCOLE (PP) 
All patients who completed the study without any major deviation from the protocol. 
To be assessable, the patient: 
1. Must meet all inclusion criteria, and not meet any of the non-inclusion criteria; 
2. Must have been through the procedure selected from randomization; 
3. Must not show any sign of post-randomization deviations that is considered as « major »: 
 Going through prohibited treatments; 
 Failure to meet protocol deadlines for visits; 
 Absence of conscent ; 
 Repeated non-compliance with protocol requirements. 
4. Must be assessable for the primary criterion. 
 
All deviations will be reviewed and classified as major/minor at a Blind Review meeting. 
Efficiency analyses will be conducted in ITT and PP.   

 
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12. 
ACCESS RIGHTS TO THE SOURCE DOCUMENTS AND DATA  
12.1. 
Rights of access to data 
People who have direct access, pursuant to current legislative and regulatory requirements and particularly articles 
L.1121-3 and R.5121-13 of the French Code of Public Health (e.g., investigators, staff responsible for quality control, 
monitors, clinical research associates, auditors and all staff requested to work in studies) will take all of the necessary 
precautions in order to ensure the confidentiality of the information relating to the investigational medicinal 
products, studies and people taking part in them, particularly with respect to their identity and the results obtained.  
The data collected by these people during quality control or audits are therefore anonymised.   
12.2. 
DESCRIPTION OF VARIABLES COLLECTED  
Data from the study will be collected directly from the e-CRF as the visits go by. These data will be validated by the 
investigator who will sign (manually or electronically) the observation notebooks. 
Here below are the collected information for this study: 
 Demographic data ; 
 Background information ; 
 Concomitant pathologies and associated treatments; 
 History of the disease; 
 Clinical examination; 
 Radiographic examination; 
 Surgical intervention ; 
 Post surgical follow-up : 
 Clinical test ; 
 Adverse events. 
 The further questionnaires will also be used: 
 
12.2.1. OSWERSTY QUESTIONNAIRE 
It helps assess the symptoms and the intensity of the lower back pain, and how it affects the patient’s daily life 
activities.  
12.2.2. SF 12 QUALITY OF LIFE QUESTIONNAIRE 
The SF 12 provides two scores: a score on the mental and social quality of life and a score on the physical quality of 
life.  
12.2.3. ASSESSMENT OF THE NEUROLOGICAL AND MOTOR STATUS 
To assess the neurological and motor status. 

 
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12.2.4. VISUAL ANALOGICAL SCALE 
 
The CRF will include a visual analogical scale of the lumbar and radicular pain (VAS).  
12.2.5. THE HOSPITAL ANXIETY AND DEPRESSION SCALE 
To assess the degree of anxiety and depression. 
 
12.3. 
IDENTIFICATION OF SOURCE DATA 
The investigator undertakes to provide direct access to the original data to COUSIN BIOTECH or to any person 
delegated to represent the company, and to the regulatory authorities.  
Original documents will consist of all of the information and results of investigations shown in the medical file of 
people taking part in the research.  
The minimum data set which will appear in the original file of patients included in the study are: 
 Participation in the study, 
 Date of information and inclusion of the patient into the study (signature of consent) 
 Date of visits,  
 Past medical and surgical history, 
 The procedure allocated to the patient, 
 concomitant treatments, 
 Development of adverse events,  
 Development of serious adverse events. 
These data must enable the different assessments made in the CRF to be “reconstructed”. 
 
 
 
 
 
 
 
 
 

 
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13. 
QUALITY CONTROL AND INSURANCE 
The research data will be collected using the 
 1 Electronic Case Report Form.  
The data will be collected in real time by the clinicians and processed in accordance with current legislation. 
Monitoring will be provided by the clinical research associates in each investigating centre throughout the duration 
of the study in order to ensure that the study is conducted correctly. 
Signature and compliance of each patient’s consent will be routinely checked.  The original documents will be 
reviewed to ensure that the data are consistent with the case report form.  Monitoring will be conducted in 
accordance with ICH E6 recommendations. 
The investigator and staff involved in the study must be available during the monitoring visits and any audits or 
inspections and provide sufficient time for these to be conducted.  
Quality control will be carried out by the Clinical Research Associate.  As the sponsor has classified this study as 
increased monitoring status which means that the CRA will carry out 1 set up visit, the number of monitoring visits 
required to check 20% of the case report forms and a closure visit in each centre.  All of the case report form data 
and the presence of all signed consents will be checked.  The presence of all signed consents will be checked. These 
visits will be carried out according to the QM standard operating procedures.  A visit report will be drawn up following 
these visits and sent within a maximum period of 7 days to the project lead who will approve these.  
The data submitted will be checked and subject to data management in accordance with QUANTA MEDICAL 
requirements and procedures and consistent with professional requirements. 
An audit may also be carried out by COUSIN BIOTECH or any organisation appointed by the sponsor or by the Health 
Authorities.  
13.1. 
RISK MINIMISATION PLAN 
The risk minimization plan which was implemented describes and qualifies (in terms of likelihood and severity) the 
risks associated with the study.  These risks are classified as follows: 
 Risks relating to participants’ rights; 
 Risks relating to participants’ safety; 
 Risks relating to the integrity of data and results.  
Reduction actions are proposed for each risk identified. 
13.2. 
QUALITY INSURANCE PLAN 
The Quality Management Plan also called the Quality Assurance Plan (QAP), is suitable for the specific features of the 
study and type of risks it involves.  
The QAP shows a list of the monitoring and control procedures which will be implemented in order to deal with non-
compliances identified with targeted corrective actions. 
                                               
1 
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13.3. 
MONITORING AND INDICATORS 
In accordance with in-house procedures, QM defines Quality and Performance indicators to be monitored and 
analysed during the study.  The indicators will be proposed during the framework meeting and decided jointly. 
An analysis of the indicators will be used to assess the quality of services provided for each project.  The Performance 
and Quality indicators will be analysed monthly. 
 
 
 
 

 
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14. 
FEASIBILITY AND TIMELINE OF THE STUDY  
The centers’ recruitment is evaluated on the basis of the number of investigators per center, and on the basis of the 
recruitment potential per center: between 1 and 2 patients per month. 
 
Inclusion curve 
 
 
 
 
 
 
 Duration of study : 84  months  
 Forecast of the inclusions start : May 2020 
 End of inclusions date : May 2022 
 End of follow up date : May  2027 
 Analyses and results : November 2027 

 
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15. 
STUDY ORGANIZATION  
15.1. 
STEERING COMMITTEE 
It will consist of the clinical project initiators, the biostatistician in charge of the project, and the promoter’s 
representatives. 
It will define the general organisation, the conduct of the research, and it will coordinate the information flow. It will 
initially determine the methodology, and during the course of research, it will decide about the right conduct if an 
unanticipated event happens. It will also monitor the research process, especially, in terms of tolerance and adverse 
events. 
The committee is made up of : the clinical project initiators (Pr Vincent POINTILLART and Dr Bertrand DEBONO) , the 
QM project manager (Rym BOULKEDID), the QM Project Director (Dr Othar ZOURABICHVILI), and of the promoter’s 
representative as well as the Promoter’s Material Supervisor. 
For the sake of the cause, the following may be assisting members of this committee: 
 
One or more investigators; 
 
Placement instructor(s); 
 
A technician: IT manager or data-management-statistic or; 
 
A specialist invided on ad hoc basis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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16. 
ETHICAL CONSIDERATIONS 
16.1. 
DECLARATION STATING THAT THE RESEARCH WILL BE CONDUCTED IN ACCORDANCE WITH THE PROTOCOL, GOOD PRACTICE 
AND CURRENT LEGISLATIVE AND REGULATORY REQUIREMENTS 
The sponsor and all investigators undertake to conduct this study in accordance with  
 
Law no. 2012-300 of 5 March 2012 on research involving human beings (the so-called Jardé law) modified 
by Order no. 2016-800 of 16 June 2016 and Decree no. 2016-1537 through which this law is applied; 
 
MEDDEV 2.7/3 revision 3 (May 2015) – Guidelines on the reporting of serious adverse events in clinical 
studies on medical devices: 
 
The Decision of 3 March 2017 setting out the form, content and methods for declaring adverse events and 
new findings in research, as described in section 1 of article L. 1121-1 of the French Code of Public Health 
(CSP) on an MD/IVDMD; 
 
The French Code of Public Health; 
 
The Declaration of Helsinki (latest version: October 2013); 
 
Good Clinical Practice (GCP);  
 
ICH (International Conference on Harmonization) recommendations and in particular ICH E6 (Good Clinical 
Practice); 
 
The law relating to data processing, files and freedoms (law n ° 78-17 amended in 2004) 
 
Deliberation no. 2018-153 of 3 May 2018 approving a reference methodology for the processing of 
personal data used in health research with recording of consent from the person concerned (MR-002) and 
rescinding deliberation no. 2016-262 of 21 July 2016; 
 
Law 2018-493 of 20 June 2018 on the protection of personal data;  
 
Standard NF EN ISO 14155 (May 2012) on clinical investigations on medical devices in human subjects. 
 
They undertake to follow all legislative or regulatory requirements which may relate to the research. 
16.2. 
PROTECTION OF PEOPLE 
The protocol will be submitted for an opinion to the Ethics Committee (EC) and to ANSM for authorisation before 
inclusions begin. 
Prior to inclusion in the study, each investigator must ensure that the patient is provided with all of the information 
about the study, in particular: 
 The plan of the study: duration, visits, samples, etc.; 
 The expected benefits and risks resulting from his/her participation; 
 The EC opinion; 
 The possibility of the patient to withdraw his/her consent at any time without giving his/her 
reasons. 
The information will be provided using the information leaflet.  This document must be initialled on each page by the 
patient and by the investigator at the inclusion visit V1. 
Once the patient has given his/her accord the patient and investigator must sign and date the consent form. 
A copy of the consent form will be given to the patient and another copy will be kept by the investigator. 

 
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16.3. 
INSURANCE 
The study sponsor has taken out insurance with …... 
16.4. 
AMENDMENT TO THE PROTOCOL 
Any substantial amendment which affects the conduct of the study or patient safety, including changes to the 
objectives of the study, the plan of the study, the population, the study procedures or important administrative 
aspects must appear as an amendment to the protocol. 
No substantial amendments to this protocol may be implemented without approval from the EC and/or authorisation 
from the Competent Authority. 
In order to be submitted, any substantial modification must carry the signature of the co-ordinating investigator, 
sponsor and QUANTA MEDICAL. Once approved the substantial amendment will be distributed for signature to all of 
the study investigators. 
 
16.5. 
BENEFIT/RISK BALANCE  
16.5.1. POTENTIAL BENEFITS 
The use of the B-DYN device in the surgical treatment of lumbar stenosis could lead to maintaining the functional 
disability related to low back pain (preservation of walking ability and mobility) compared to fusion processing; it 
also helps maintain the level’s mobility, while respecting the sagittal balance. 
 
The hypothesis expresses that patients in the experimental group (B-DYN) will have less long-term adjacent syndrome 
compared to patients who have had a fusion. 
 
16.5.2. POTENTIAL RISKS 
This research does not entail any additional risk compared to the risk incurred during surgeries for the management 
of lumbar stenosis. 
The complications are essentially those related to the surgical procedure: 
 Complications of general anesthesia: these complications are detailed in the information sheet 
of the French Society of Anesthesia and Resuscitation, and are identical to those of any 
general anesthesia. 
  Complications related to any surgery on the spine. We will mention infections, hemorrhage, 
pain, leakage of the cerebrospinal fluid, loss of neurological functions, etc. These 
complications will all be presented to you by your surgeon before the procedure. The 
treatment of these complications is well known and the investigative doctor knows how to 
take them in charge 
 
Other complications that may arise are related to the medical device itself: 
 Early or late loosening of any or all of the components  

 
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 Disassembly, bending and/or breakage of any or all of the components (screw breakage)  
 Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, 
and/or general corrosion), including metallosis, tumor formation and/or autoimmune disease  
 Pressure on the skin from components parts with inadequate tissue coverage over the 
implant possibly causing skin penetration, irritation, fibrosis, neurosis, and/or pain  
 Tissue or nerve damage caused by improper positioning and placement of implants or 
instruments  
 Post-operative change in spinal curvature, loss of correction, height, and/or reduction 
 
 
 
17. 
PROCESSING OF DATA AND STORAGE OF RESEARCH DOCUMENTS 
AND DATA 
17.1. 
DATA CIRCUIT 
 
The QUANTA VIEW® application is: 
 
Modular;  
 
Multi-project;  
 
Multi-country, multi-lingual; 
 
Broadly configurable;  
 
Developed by Quanta Medical (proprietary application);  
 
Equipped with the functions needed for interventional and non-interventional studies. 
QUANTA VIEW® 
 
Enables real-time project management from the centre-recruitment phase through to freezing of 
the database and study close-out; 
 
Brings together all stekeholders within a highly collaborative system based upon WorkFlow systems, 
by providing each with a pragmatic overview of actions to be performed and events to monitor. 
QUANTA VIEW® comprises 3 modules: 
 QUANTA VIEW® e-CRF or CDMS (Clinical Data Management System) 
 Open solution for data input by the investigators and for data management operations. 
 QUANTA VIEW® CTMS (Clinical Study Management System)  
 Management of professionals;  
 Management of patients;  
 Logistical monitoring.  
 QUANTA VIEW® CPMS (Collaborative Portal Management System) provides the following functions: 
 Progress indicators for the project;  
 Document access and sharing;  

 
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 Printout of status reports2:   
 monitoring of recruitment;  
 monitoring of patients by type;  
 monitoring of health care professionals;  
 monitoring of data management; 
 monitoring of logistics.  
 
QUANTA VIEW® with its modularity can be readily adapted to projects and integrated wherever necessary into 
specific programs. 
Version 5.300 of QUANTA VIEW® is in production on Quanta Medical servers hosted at the company site in Rueil-
Malmaison. 
QUANTA VIEW ® provides access for the the different project team members from:  
 Quanta Medical; 
 The Sponsor;  
 The study centres.  
 
 
The user guide, which is specifically dedicated to the study, is sent out prior to training of the investigators and staff 
allocated to data entry takes place. 
This guide is available through the QUANTA VIEW® portal 
User training is provided by the QM CRA during the set up visit. 
Users are assisted through: 
 
A 2 level Hotline accessible through a toll-free number. 
17.2. 
METHODS FOR PROCESSING, VERIFICATION AND VALIDATION OF DATA (DATA MANAGEMENT)  
The study will be collected using a 
electronic Case Report Form3 
The data will be collected in real-time by the clinicians. 
For this research, the subjects will be identified as follows: centre No. (3 numerical positions) - Selection order No. of 
the person in the centre (2 numerical positions) - surname initial - first name initial. This reference is unique and will 
be retained for the entire research period, in all documents necessary for the study, or by erasing (using suitable 
means) all the data on copies of documents source used for the research documentation.  
The data management process is monitored in a QL (Quality Log) bringing together all key steps in the process. This 
QL also provides a medium for evaluation of the indicators applicable to the project.  
There are 2 types of control: 
 
Online checks during data entry by investigators with display of an error message in the event of any 
anomaly; 
 
Checks of the data entered enabling the generation of queries at specified intervals.  
                                               
 
™ is a registered trademark of QUANTA MEDICAL™ 
in Excel format 
3 
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17.2.1. DATA MANAGEMENT 
 
Data management process and actions (deliverables:) 
 
In order to minimise the involvement of the investigators, QM proposes to set parameters for obvious corrections, 
which may be made with the agreement of the sponsor according to rules which will be defined in the Data-
management manual. 
17.2.2. BLIND REVIEW AND LOCKING OF THE DATABASE 
The blind review will be prepared in order to present the patients and their data to the committee, which will then 
decide on classification of the deviations. The database will be locked after validation of the blind review repot. 
17.3. 
ARCHIVING OF STUDY DOCUMENTS  
It is the responsibility of the investigator to archive sufficient information about the identity of subjects taking part 
in the study in order to be able to provide these to the Health Authorities or sponsor if necessary. 
The documents relating to the study are: 
 The signed copy of the technical protocol;  
 The investigator brochure; 
 The financial agreement; 
 The curricula vitae; 
 The list of task delegations; 

 
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 The forms (originals), completed and signed, of the informed consent for each of the patients 
included; 
 The copy of the Ethics Committee approval letter; 
 The certification of insurance taken out by the sponsor; 
 The copy of the data processing form (given to patient/returned to the investigator);  
 The acknowledgements of receipt of the study materials; 
 The list of patients included in the study (surnames, forenames, number and inclusion date, 
hospital file if applicable); 
 The list of  participating investigators; 
 The copy of each patient’s case report form or a print-out of patient data (document approved 
by the investigator); 
 The originals of the original documents for each of the patients included; 
 All correspondence relating to the study. 
These documents must be stored for a minimum period of fifteen (15) years after the end of the study.  
 
 
 
 
 
18. 
DATA OWNERSHIP - PUBLICATIONS OF RESULTS 
It is agreed that the results of this study may not be presented in scientific meetings or published in scientific journals 
or on any other support without the prior written agreement of the sponsor.  This also applies to any amendment 
which may be requested by an editor, review committee or editorial committee. 
The members of the expert panel for this study may appear as co-authors of this publication 
Will be first and last signatories of the publications, the person who really participated in the development of the 
protocol and its progress and the writing of the scientific article. Will also be signatories of the article investigators 
who included the number of patients required during the recruitment period. 
The authors will jointly agree on the choice of the journal for the first publication to which they will grant rights for 
first publication. 
. The sponsor reserves the right to use the results of this study in its medical information and to distribute reprints 
of publications. 
The authors will accord their authorship copy right laws and rights of representation and reproduction, including 
translation into any language, on any support, by any means, worldwide, for any publications about this study. 
Third parties may not use these rights without the prior written agreement of the sponsor. 
 

 
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19. 
BIBLIOGRAPHIC REFERENCES  
 
1.  
Ravindra VM, Senglaub SS, Rattani A, et al (2018) Degenerative Lumbar Spine Disease: Estimating Global 
Incidence and Worldwide Volume. Global Spine J 8:784–794. https://doi.org/10.1177/2192568218770769 
2.  
Rajaee SS, Bae HW, Kanim LEA, Delamarter RB (2012) Spinal fusion in the United States: analysis of trends from 
1998 to 2008. Spine 37:67–76. https://doi.org/10.1097/BRS.0b013e31820cccfb 
3.  
Weinstein JN, Lurie JD, Olson PR, et al (2006) United States’ trends and regional variations in lumbar spine 
surgery: 1992-2003. Spine 31:2707–2714. https://doi.org/10.1097/01.brs.0000248132.15231.fe 
4.  
Turner JA, Ersek M, Herron L, Deyo R (1992) Surgery for lumbar spinal stenosis. Attempted meta-analysis of 
the literature. Spine 17:1–8. https://doi.org/10.1097/00007632-199201000-00001 
5.  
Machado GC, Ferreira PH, Yoo RI, et al (2016) Surgical options for lumbar spinal stenosis. Cochrane Database 
Syst Rev 11:CD012421. https://doi.org/10.1002/14651858.CD012421 
6.  
Desai A, Bekelis K, Ball PA, et al (2013) Variation in outcomes across centers after surgery for lumbar stenosis 
and degenerative spondylolisthesis in the spine patient outcomes research trial. Spine 38:678–691. 
https://doi.org/10.1097/BRS.0b013e318278e571 
7.  
Försth P, Ólafsson G, Carlsson T, et al (2016) A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal 
Stenosis. N Engl J Med 374:1413–1423. https://doi.org/10.1056/NEJMoa1513721 
8.  
Ghiselli G, Wang JC, Bhatia NN, et al (2004) Adjacent segment degeneration in the lumbar spine. J Bone Joint 
Surg Am 86:1497–1503. https://doi.org/10.2106/00004623-200407000-00020 
9.  
Xia X-P, Chen H-L, Cheng H-B (2013) Prevalence of adjacent segment degeneration after spine surgery: a 
systematic review and meta-analysis. Spine 38:597–608. https://doi.org/10.1097/BRS.0b013e318273a2ea 
10.  Gillet P (2003) The fate of the adjacent motion segments after lumbar fusion. J Spinal Disord Tech 16:338–345. 
https://doi.org/10.1097/00024720-200308000-00005 
11.  Deyo RA, Mirza SK, Martin BI, et al (2010) Trends, Major Medical Complications, and Charges Associated with 
Surgery 
for 
Lumbar 
Spinal 
Stenosis 
in 
Older 
Adults. 
JAMA 
303:1259–1265. 
https://doi.org/10.1001/jama.2010.338 
12.  Groff MW (2014) Introduction: Guideline update for the performance of fusion procedures for degenerative 
disease 
of 
the 
lumbar 
spine. 
Journal 
of 
Neurosurgery: 
Spine 
21:1–1. 
https://doi.org/10.3171/2014.4.SPINE14190 
13.  Rushton A, White L, Heap A, Heneghan N (2015) Evaluation of current surgeon practice for patients undergoing 
lumbar 
spinal 
fusion 
surgery 
in 
the 
United 
Kingdom. 
World 
J 
Orthop 
6:483–490. 
https://doi.org/10.5312/wjo.v6.i6.483 
14.  Matz PG, Meagher RJ, Lamer T, et al (2016) Guideline summary review: an evidence-based clinical guideline 
for the diagnosis and treatment of degenerative lumbar spondylolisthesis. The Spine Journal 16:439–448. 
https://doi.org/10.1016/j.spinee.2015.11.055 

 
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15.  Tachibana N, Kawamura N, Kobayashi D, et al (2017) Preventive Effect of Dynamic Stabilization Against 
Adjacent 
Segment 
Degeneration 
After 
Posterior 
Lumbar 
Interbody 
Fusion. 
Spine 
42:25–32. 
https://doi.org/10.1097/BRS.0000000000001654 
16.  Lee JC, Kim Y, Soh J-W, Shin B-J (2014) Risk Factors of Adjacent Segment Disease Requiring Surgery After 
Lumbar Spinal Fusion: Comparison of Posterior Lumbar Interbody Fusion and Posterolateral Fusion. Spine 
39:E339–E345. https://doi.org/10.1097/BRS.0000000000000164 
17.  Wang JC, Arnold PM, Hermsmeyer JT, Norvell DC (2012) Do lumbar motion preserving devices reduce the risk 
of adjacent segment pathology compared with fusion surgery? A systematic review. Spine 37:S133-143. 
https://doi.org/10.1097/BRS.0b013e31826cadf2 
18.  Radcliff KE, Kepler CK, Jakoi A, et al (2013) Adjacent segment disease in the lumbar spine following different 
treatment interventions. Spine J 13:1339–1349. https://doi.org/10.1016/j.spinee.2013.03.020 
19.  Morishita Y, Ohta H, Naito M, et al (2011) Kinematic evaluation of the adjacent segments after lumbar 
instrumented surgery: a comparison between rigid fusion and dynamic non-fusion stabilization. Eur Spine J 
20:1480–1485. https://doi.org/10.1007/s00586-011-1701-1 
20.  Sears WR, Sergides IG, Kazemi N, et al (2011) Incidence and prevalence of surgery at segments adjacent to a 
previous posterior lumbar arthrodesis. Spine J 11:11–20. https://doi.org/10.1016/j.spinee.2010.09.026 
21. Imagama S, Kawakami N, Matsubara Y, et al. Preventive effect of artificial ligamentous stabilization on the upper 
adjacent segment impairment following posterior lumbar interbody fusion. Spine (Phila Pa 1976) 
2009;34:2775–81. 
 
 
 
 
 
 
 
 
 
 
 
 

 
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20. 
APPENDIX 
 
 
 
 
 

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20.1. 
 STUDY FLOW CHART 
 
Visits 
V1 
Inclusion  
V2  
intra- & 
post-op 
V3 
Follow up 
V4 
Follow up 
V5 
Follow up 
Additional visits 
       
Data to be collected or 
Tests to be done  
 
D0 
M2 
(± 7 d) 
M12 
(± 30 d) 
M60 
(± 60 d) 
Consultation or hospitalisation 
Information and signature of the consent  
 ✔ 
  
  
  
  
  
Medical history 
✔ 
  
  
  
  
  
History of the disease  
✔ 
  
  
  
  
  
Inclusion / non-inclusion criteria  
✔ 
  
  
  
  
  
Clinical test 
✔ 
✔ 
✔ 
✔ 
✔ 
✔ 
Randomization and allocation of intervention 
 ✔ 
  
  
  
  
  
Intra-post-op. Immediat data collection  
  
✔ 
  
  
  
  
Case Report Form (CRF) 
✔ 
✔ 
✔ 
✔ 
✔ 
✔ 
Oswestry Disability Index 
✔ 
  
✔ 
✔ 
✔ (sup) 
✔ 
Quality of life questionnaire (SF-12) 
 ✔ 
  
✔ 
✔ 
✔ (sup) 
  
Motion and sensitivity assessment 
✔ 
 
✔ 
✔ 
✔ (sup) 
 
VAS (low back pain and radicular pain) 
✔ 
✔ 
✔ 
✔ 
✔ (sup) 
  
Anxiety (HAD score) 
✔ (sup) 
  
✔ (sup) 
✔ (sup) 
✔ (sup) 
 
Walking distance 
✔ 
 
✔ 
✔ 
✔ (sup) 
 
MRI  
✔ 
  
  
 ✔ (sup) 
✔ (sup) 
  
Radiography (Télé-rachis or EOS)  
✔ 
  
✔  
✔  
✔ (sup) 
  
Dynamic Radiograph  
✔ 
 
✔ 
✔ 
✔ (sup) 
✔ 
AE (Adverse event)  collection 
  
✔ 
✔ 
✔ 
✔ 
✔ 
Collect of concomitant treatments 
  
✔ 
✔ 
✔ 
✔ 
✔ 
Supp : Additional tests compared to common practice
Days 

 
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20.2. 
B-DYN DESCRIPTION 
 
 
 
 
 
 
 
 
 
 
 
 

 
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20.3. 
INSTRUCTION FOR USE  
 
 
 
 
 

 
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20.4. 
SURGICAL PROCEDURE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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20.5. 
CE MARKED CERTIFICATE  
 
 
 

 
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20.6. 
OSWESTRY DISABILITY INDEX 
 
 
 
 

 
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20.7. 
SF-12 
 
 
 

 
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20.8. 
NEUROLOGICAL AND MOTOR STATUS ASSESSMENT  
Neurological and motor status 
 
Motor deficit (MRC scale) 
L4 
L5 
S1 
Left 
Right 
Left 
Right 
Left 
Right 
  0 
  1 
  2 
  3 
  4 
  5 
  0 
  1 
  2 
  3 
  4 
  5 
  0 
  1 
  2 
  3 
  4 
  5 
  0 
  1 
  2 
  3 
  4 
  5 
  0 
  1 
  2 
  3 
  4 
  5 
  0 
  1 
  2 
  3 
  4 
  5 
 
 
 
 
 
Sensory assessment  
Light touch 
L4 
L5 
S1 
Left 
Right 
Left 
Right 
Left 
Right 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
 
Pin Prick 
 
 
 
 
L4 
L5 
S1 
Left 
Right 
Left 
Right 
Left 
Right 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 
  0 : Absent 
  1 : Altered 
  2 : normal  
 

 
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20.9. 
HAD SCALE  
 
 
 

 
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20.10. SERIOUS ADVERSE EVENT (SAE) RECORDING FORM 
 
 
Form for the notification of a serious adverse 
event (SAE) occurring during Research on a 
Human Being  
Medical device  
BOX RESERVED FOR SPONSOR 
 
DATE OF RECEIPT: ___ /_____ /______ 
 
SAE N° |__|__|__| 
 
 
  
Initial notification 
                                                                            SAE follow-up 
  
 
1. Identification of the research  
Acronym:  
BDYNCLIN  
Research number:  
2834_BDYNCLIN 
Full title of the research involving Human 
Beings:  
 
“Study of the efficacy and tolerance of the B-Dyn medical device compared to a 
conventional bolted fusion with or without cage in the treatment of degenerative 
lumbar stenosis, with or without grade I spondylolisthesis on the degree of 
postoperative functional disability, preservation of mobility and prevention of the 
adjacent syndrome". 
Interventional, prospective, comparative, randomized, non-inferiority, single blind, 
international, multicenter clinical study. 
 
2. Identification of the centre  
 
Institution name: ……………………………………………………………………………………………………… 
Town and post code: ………………………………………………………………………………………………………………… 
Department: ………………………………………………………………………………………………………………………………………… 
 
3. Identification and past history of the person taking part in the research  
Patient N°:  
|__|__|__| - |__|__| - |__| - |__|  
 Centre No. – patient selection  no. – initials – initial  
 surname, forename  
Sex:  
 M 
 F 
Weight:  
|__|__|__| kg 
Height:  
|__|__|__| cm 
Date of birth: 
 
|__|__| |__|__| |__|__|__|__| 
    dd        mm             yyyy 
Past medical and surgical history  
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………………………………… 
Date of signature of consent: 
|__|__| |__|__| |__|__|__|__| 
 dd        mm             yyyy 
Date of randomisation: 
|__|__| |__|__| |__|__|__|__| 
dd        mm             yyyy 
Randomisation arm  
 
 BDYN    
 Fusion 
 

 
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4. Surgical procedure before the development of the SAE  
(delete box if treatment not started)  
 
Date of the procedure (dd/mm/yyyy) 
Batch no.  
BDYN 
 
|__|__| |__|__| |__|__|__|__| 
………………………………………………………………………… 
Fusion 
 
|__|__| |__|__| |__|__|__|__| 
 
 
 
 
5. Serious adverse event [SAE] 
Name: 
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………………………… 
……………………………………………………………………………………………………… 
 
Description: 
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………………………… 
……………………………………………………………………………………………………… 
……………………………………………………………………………………………………… 
Body site 
 
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………………………………… 
……………………………………………………………………………………………………… 
 
Date of onset of the SAE: 
 
|__|__| |__|__| |__|__|__|__| 
 dd        mm             yyyy 
Severity 
 
 Death: |__|__| |__|__| |_2_|_0_|__|__| 
 
 Life-threatening for patient 
 
 Important medical event  
 
 Hospitalisation (initial or prolonged): 
 
from |__|__| |__|__| |_2_|_0_|__|__| 
 
to |__|__| |__|__| |_2_|_0_|__|__|       
 ongoing  
 
 Disability or  incapacity  
 Other(s) , give details: 
……………………………………………………………………………………………………… 
……………………………………………………………………………………………………… 
Did the patient receive any 
treatment for this SAE?  
Yes 
No 
If yes, specify: 
Medical 
Yes 
No 
 
If medical treatment specify: ……………………………………… 
Surgical 
Yes 
No 
If surgical treatment, specify measures taken regarding the device 
 Removal  
 Total replacement  
 Re-adjustment  
 Other  
If other, specify procedures performed: ……………………………………… 
Date of surgery: |__|__| |__|__| |_2_|_0_|__|__| 
Outcome of event  
 Resolved:  
  without sequelae 
  with sequelae, specify which: 
Date: |__|__| |__|__| |__|__|__|__| 
              dd        mm             yyyy 
duration if < 24 h |__|__| h 
|__|__| min 
  
 Not resolved (ongoing), specify: 
 Stable state  Improved  Deteriorated 
 
 

 
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 Death  
  unrelated to the SAE  
  related to the SAE  
Date 
of 
death: 
|__|__| 
|__|__|  
|__|__|__|__| 
 dd mm yyyy 
  
 
 
 
 Not assessable  
 
 
Place of onset  
 Home  
 Day hospital  
 Hospital  
 Convalescence home  
 
 
 
 
6. In the opinion of the investigator, is the serious adverse event (several options possible)   
related to the research medical device?  
 
 Unlikely  
Possible  
 Probable  
Certain 
 
related to the surgical procedure?  
 Unlikely  
Possible  
 Probable  
Certain 
 
related to another event:  
 
Yes 
No 
 If yes, specify:  
                                  progression of the disease on which the research was being conducted 
Yes 
No 
 to one (or more) concomitant medicinal product(s) 
Yes 
No 
 if yes, which: ………………………………………………………………………….. 
 to an intercurrent disease, 
Yes 
No 
 If yes, which: ………………………………………………………………………………………………………………………………………… 
 other, 
Yes 
No 
If yes, specify: ……………………………………………………………………………………………………………………………………… 
 
7. Device defect  
Yes 
 No 
If yes, specify,  
 
 
 
 
Notifier  
Investigator  
Name and position: 
 
 
 
Signature 
Name:  
 
 
 
Signature 
 
Please send this form to: 
Franck Pelletier 
Head of Devices Vigilance  
Fax: 03.20.14.40.13 
E-mail: f.pelletier@cousin-biotech.com