Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2
Conditions: Revision Total Hip Arthroplasty, Primary Total Hip Arthroplasty
Sponsor: Dedienne Sante S.A.S.

 
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RETROSPECTIVE OBSERVATIONAL COHORT STUDY SYMBOL CUP 2 
 
 
SYMCOR-2  
 
 
Version N°1.0- Date: 16-APR-2018 
 
 
Investigator 
Dr. Gilles ESTOUR 
 
Sponsor 
DEDIENNE SANTE SAS represented by Ludovic TOLEDO 
Methodology & Biometrics 
Prof. Dr. Frédéric DAOUD 
 
 
 
This document is the exclusive property of the sponsor. It may not be copied, reproduced or 
communicated, in whole or in part, without written authorization.   
 
 

 
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KEY STAKEHOLDERS  
Sponsor  
DEDIENNE SANTE S.A.S. 
SIRET: 339 138 638 00053 
217, rue Charles Nungesser, 34130 Mauguio 
Represented by TOLEDO Ludovic, General Director 
Phone: 04 67 99 81 11 
Mail: l.toledo@menix.fr 
Investigator  
Dr. Gilles ESTOUR 
RPPS 10004039441 
Orthopedic Surgeon  
MEDIPOLE DE SAVOIE 
Avenue des Massettes  
73190 Challes-les-Eaux  
Phone: 04 79 26 81 17 
Mail: gillestour@yahoo.com 
Methodology 
and 
data 
management: place of data 
processing 
 
Dr. Frédéric DAOUD 
RPPS 10000548973 
Epidemiologist, biostatistician. 
MEDEXTENS SARL 
75 rue de Lourmel, 75015 Paris 
Phone: 06 03 00 68 98 
Mail: fcdaoud@medextens.com 

 
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PROTOCOL UPDATE HISTORY 
VERSION 
DATE 
REASON FOR UPDATE 
1.0 
16/04/2018 
Final version  
 
 
 
 
 
 
 
 
 
 
 

 
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1. 
SUMMARY OF THE STUDY 
6 
2. 
STUDY RATIONALE / SCIENTIFIC JUSTIFICATION 
7 
2.1. 
CURRENT KNOWLEDGE OF THE PATHOLOGY 
7 
2.2. 
STATE OF KNOWLEDGE ON THE DEVICES UNDER EVALUATION 
10 
2.3. 
STUDY HYPOTHESES AND EXPECTED RESULTS 
11 
3. 
STUDY OBJECTIVES AND ENDPOINTS 
11 
3.1. 
MAIN OBJECTIVE 
11 
3.2. 
PRIMARY ENDPOINT 
12 
3.3. 
SECONDARY OBJECTIVE 
12 
3.4. 
SECONDARY ENDPOINTS 
12 
4. 
DESCRIPTION OF THE STUDY 
12 
4.1. 
DESCRIPTION OF MEASURES TAKEN TO REDUCE AND AVOID BIAS 
12 
5. 
STUDY FEASABILITY 
13 
6. 
REALISATION PRATIQUE DU PROTOCOLE. 
13 
6.1. 
DEROULEMENT DES VISITES LIEES A L’ETUDE 
13 
6.2. 
SUMMARY OF PATIENT FOLLOW-UP 
14 
6.3. 
DESCRIPTION OF THE GENERAL LOGISTICAL ORGANIZATION OF THE STUDY 
14 
6.4. 
BIOLOGICAL SAMPLES AND ANALYSES 
14 
7. 
ELIGIBILITY CRITERIA 
14 
7.1. 
INCLUSION CRITERIA 
14 
7.2. 
NON-INCLUSION CRITERIA 
14 
7.3. 
RECRUITMENT PROCEDURES 
15 
8. 
RULES FOR STOPPING THE STUDY 
15 
8.1. 
TERMINATION OF THE STUDY BY THE SPONSOR 
15 
8.2. 
TERMINATION OF THE STUDY BY THE INVESTIGATOR 
15 
9. 
DATA COLLECTED 
15 
10. 
STATISTICAL CONSIDERATIONS 
15 
10.1. 
NUMBER OF SUBJECTS TO BE INCLUDED 
15 
10.2. 
DATA ANALYSIS – GENERAL INFORMATION: DESCRIPTIVE APPROACH 
15 
10.3. 
MAIN ANALYSIS 
16 
10.4. 
SECONDARY ANALYSES 
16 
10.5. 
SAMPLING FRAME 
16 
10.6. 
METHOD FOR TAKING INTO ACCOUNT MISSING, UNUSED OR INVALID DATA 
16 
10.7. 
PERSON RESPONSIBLE FOR THE ANALYSIS 
16 

 
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11. 
ACCESS RIGHTS TO SOURCE DATA AND DOCUMENTS 
17 
11.1. 
DATA ACCESS 
17 
11.2. 
SOURCE DATA 
17 
11.3. 
DATA PRIVACY 
17 
12. 
ETHICAL CONSIDERATIONS 
18 
12.1. 
INDEPENDENT ETHICS COMMITTEE 
18 
12.2. 
PATIENT INFORMATION 
18 
12.3. 
SUPPORT FOR STUDY 
18 
13. 
DATA PROCESSING AND STORAGE OF DOCUMENTS AND DATA RELATING TO THE 
STUDY 
19 
13.1. 
DATA ENTRY AND PROCESSING 
19 
13.2. 
CNIL 
19 
13.3. 
ARCHIVING 
19 
14. 
COMMUNICATION – PUBLICATION RULES 
19 
15. 
INVESTIGATOR CONTRACT 
20 
16. 
LIST OF ANNEXES 
20 
17. 
ASSOCIATED DOCUMENTS 
20 
18. 
BIBLIOGRAPHY 
37 
 

 
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1. SUMMARY OF THE STUDY 
TITLE 
Retrospective Observational Cohort Study SYMBOL CUP 2 
SHORT TITLE 
SYMCOR-2 
INVESTIGATOR 
Dr. Gilles ESTOUR 
SPONSOR 
DEDIENNE SANTE S.A.S. 
JUSTIFICATION / 
CONTEXT 
Documentation of the clinical efficacy and safety of SYMBOL CUP 
DMR HA and SYMBOL CUP DM CEM dual mobility acetabular 
implants. 
METHODOLOGY  
Retrospective observational cohort study 
MAIN OBJECTIVE  
Estimate the safety of these implants under normal conditions of use 
PRIMARY ENDPOINT 
Implant survival rate at 2-year follow-up 
SECONDARY OBJECTIVE  
Estimate the efficacy of these implants under normal conditions of use 
SECONDARY ENDPOINTS 
- 
Safety: Intra and extra-prosthetic dislocation rates 
- 
Safety: Incidence of other adverse events  
- 
Effectiveness:  Harris Hip Score (HHS) 
- 
Effectiveness: Devane classification  
- 
Effectiveness:  Charnley classification 
INCLUSION CRITERIA  
- 
Any patient operated by Dr. Estour who has undergone hip 
replacement surgery with SYMBOL CUP DMR HA or SYMBOL 
CUP CEM acetabular implant. 
- 
Patient having reach 2-year follow-up on March 01, 2018 
NON-INCLUSION 
CRITERIA 
- 
Explicit refusal by the patient to allow data describing his 
pathology and treatment to be included in this study. 
- 
Minor patients or patients under guardianship. 

 
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RESEARCH PROCESS 
Retrospective collection of clinical data: 
- 
Recorded in the orthopedic surgery department’s patient files, 
from the patient’s pre-surgical assessment to the latest news at 2-
year follow-up.  
- 
Obtained by telephone interview for data up to 2-year follow-up, 
if the medical file does not provide all the source information. The 
telephone interview will be carried out by the investigator (or his 
secretariat) or by a clinical research associate delegated by the 
sponsor and approved by the investigator.   
NUMBER OF SUBJECTS    
Minimum total number of subjects: n=20 
PLANNED NUMBER OF 
CENTERS 
Single-center, single-investigator study 
PROVISIONAL STUDY 
TIMETABLE  
CPP notice: N.A. 
CEREES notice: N.A. 
CNIL receipt: 2176595 
Start of the study: As soon as CNIL receipt is received.  
Duration of inclusion period/data collection: N.A. given retrospective 
nature 
Duration of participation of each subject: N.A. given retrospective nature 
Anticipated end of study: N.A. given retrospective nature 
End-of-study report: Within 30 days of start of study 
STATISTICAL DATA 
ANALYSIS  
- 
Descriptive statistics: preoperative, operative, postoperative 
- 
Tabulation of adverse events 
- 
Kaplan-Meier analysis of implant survival 
- 
Comparison tests of preoperative versus 1-year and 2-year 
postoperative efficacy scores.   
2. STUDY RATIONALE / SCIENTIFIC JUSTIFICATION  
2.1. CURRENT KNOWLEDGE OF THE PATHOLOGY 
Hip replacement is the last therapeutic resort for symptomatic coxopathies, the incidence of which is 
estimated at over 85,000 patients per year, if hip replacement is considered as an indicator of this 

 
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pathology, according to data from the Programme de Médicalisation des Systèmes d’Information 
(PMSI).  
In the report of 2014, the Haute Autorité de Santéi, recommends the use of dual-mobility acetabular 
implants: 
- 
In first-line arthroplasties in patients with a very high risk of dislocation (severe neurological 
impairment, neuropsychiatric disorders, addiction, and major neuromuscular failures),  
- 
And revision arthroplasties in case of iterative dislocation and in patients at high rik of 
dislocation,   
- 
Depending on the clinical situation, press-fit fixation is the preferred method of fixation for the 
metal-back dual mobility acetabular cups, when the bone bed is of good quality.  
In current practice, dual-mobility acetabular implants with cemented fixation in a cross shell, or with 
cortical screws and peg, are chosen when damage to the bed bone is extensive and does not allow direct 
press-fit implantation. This is particularly the case in revision surgery.  
 
SYMBOL CUP DMR HA acetabular implants comprise metal-back cup with cortical screw fixation 
and peg fixation and the same DUAL MOBILITY PE LINER dual-mobility polyethylene insert as in 
all acetabular implants in the SYMBOL CUP DM range (Table 1, Figure 1). 
 
Table 1 : SYMBOL CUP DMR HA with cortical screw and pegs: technical specifications 
RANGE (Manufacturer) 
SYMBOL CUP 
DMR HA 
(Dedienne 
Santé) 
Also sold under the brand names: GYRACUP Ultimate 
(AESCULAP), DS Evolution (MATHYS  Ltd.) 
  
Cups 
Model 
Symbol Cup DMR HA 
Diameter range 
44 to 68mm 
Metal-back material 
Co-Cr (ISO 5832-4) 
Coating 
Ti +HAP (ISO 13779-2) 
Fixation 
* Press-Fit + 
Tripod 
* 2 pegs through holes in cups 
* 1 cortical screw in 
the flange 
Liners 
Model 
Dual Mobility PE Liner 
Material 
polyethylene ISO 5834-2 UHMWPE 
Diameter range 
44 to 68mm 
Range of diameters for 
corresponding femoral heads  
22,2mm or 28mm 
 
 
 
 
 

 
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Figure 1 Photos of SYMBOL CUP DMR HA and PE LINER medical devices. 
 
SYMBOL CUP DM CEM acetabular implants comprise a metal-back cup designed to be cemented to 
the surrounding bone, and the same DUAL MOBILITY PE LINER dual-mobility polyethylene insert 
as in all acetabular implants in the SYMBOL CUP DM range (Table 2, Figure 2). 
Table 2 : SYMBOL CUP DM CEM to be cemented: technical specifications. 
RANGE (Manufacturer) 
SYMBOL CUP DM 
CEM (Dedienne 
Santé) 
Also sold under the brand names: 
GYRACUP E (AESCULAP), DS 
Evolution (MATHYS  Ltd.) 
 
Cups 
Model 
Symbol Cup DM CEM 
Diameter range 
44 to 68mm 
Metal-back material 
Co-Cr (ISO 5832-4) 
Coating 
N.A 
Fixation 
Cement 
Liners 
Model 
Dual Mobility PE Liner 
Material 
polyethylene ISO 5834-2 UHMWPE 
Diameter range 
44 to 68 mm 
Range of diameters for corresponding 
femoral heads  
22,2mm or 28mm 
Figure 2 Photos of SYMBOL CUP DM CEM and PE LINER medical devices. 
 

 
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2.2. STATE OF KNOWLEDGE ON THE DEVICES UNDER EVALUATION 
SYMBOL CUP DMR HA and SYMBOL CUP DM CEM are class III implantable devices according to 
rule N°20 of the decree of April 20, 2006, laying down the rules for the classification of medical devices 
(transposition of Annex IX of directive 93/42/EEC and Directive 2005/50/EC). 
These implants have been introduced on the market in France and elsewhere in Europe since the EC 
declaration of conformity of April 09, 2014ii. Conformity in based in particular on: 
- 
Certificate N°27262 of device design examination according to Annex II section 4 if Directive 
93/42/EEC issued by the Notified Body LNE/G-MED N°0459, updated by revision 5 dated 
September 01, 2015.iii 
- 
The clinical evaluation « Cotyles de hanche, double mobilité, SYMBOL CUP DM » dated 
28/11/2013 performed by Dedienne Santé, updated on 28/11/2014.iv 
- 
And the validation of the clinical evaluation report by the Notified Body LNE/G-MED.v 
The clinical evaluation of SYMBOL CUP DMR HA and SYMBOL CUP DM CEM as part as CE 
conformity is based on a literature review of equivalent products, with no data specific to these products.  
Nevertheless, the CE mark has authorized SYMBOL CUP DMR HA to be reimbursed by the French 
health insurance, under the Liste des Produits et Prestations Remboursables, under generic code 
3168042 (reconstruction cup, modular, metal-back, without insert, uncemented) and SYMBOL CUP 
DM CEM under generic code 3150450 (standard cup, modular, metal-back, without insert, cemented). 
In both cases, the insert was covered under generic code 3161130 (solid polymer insert). The patients 
identified for this retrospective study benefited from reimbursement of the implant according to these 
generic codes. 
 
Given the relatively recent market introduction of SYMBOL CUP DMR HA and SYMBOL CUP DM 
CEM, a patient cohort with a minimum 2-year follow-up, 2-year follow-up data and sufficient numbers 
was only reached in 2018. The retrospective study proposed here is therefore the first clinical evaluation 
specific to these products. 
The number of units of SYMBOL CUP DMR HA and SYMBOL CUP DM CEM fitted in France are 
summarized in Table 3 and Table 4 respectively. 
 
 
 
 

 
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Table 3 : SYMBOL CUP DMR HA: Sales volume in France under this brand 
Year 
2014 
2015 
2016 
2017 
Provisional 
2018 
In public healthcare facilities 
0 
0 
4 
8 
16 
In non PHSPH private 
healthcare facilities 
15 
194 
98 
128 
155 
Total 
15 
194 
102 
136 
171 
Table 4 : SYMBOL CUP DM CEM: Sales volume in France under this brand 
Year 
2014 
2015 
2016 
2017 
Provisional 
2018 
In public healthcare facilities 
0 
0 
0 
20 
50 
In non PHSPH private 
healthcare facilities 
19 
172 
76 
180 
360 
Total 
19 
172 
76 
200 
410 
 
The specific data resulting from this study will be used to establish the benefit-risk ratio of SYMBOL 
CUP DMR HA and SYMBOL CUP DM CEM. This information will enable: 
- 
Update of the clinical evaluation for CE mark renewal purposes.   
- 
An assessment of the product’s application for inclusion in the Liste des Produits et Prestation 
Remboursables under the brand names by the Haute Autorité de Santé. 
2.3. STUDY HYPOTHESES AND EXPECTED RESULTS 
The aim of this observational study is to estimate the risk and benefit of this implant in current clinical 
practice. As the approach is descriptive, no hypotheses have been made concerning the incidence of 
adverse events, or variations in endpoints during follow-up.  
 
3. STUDY OBJECTIVES AND ENDPOINTS 
3.1. MAIN OBJECTIVE  
Estimate the safety of these implants under normal conditions of use.  

 
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3.2. PRIMARY ENDPOINT  
Implant survival rate at 2-year follow-up. This is the probability over time that the implant will remain 
in place in the living patient’s hip. Events that reduce this probability are revision surgeries with removal 
of the implant, for whatever reason.  
3.3. SECONDARY OBJECTIVE  
Estimate the efficacy of these implants under normal conditions of use.  
3.4. SECONDARY ENDPOINTS 
- 
Safety: Intra and extra-prosthetic dislocation rates 
- 
Safety: Incidence of other adverse events  
- 
Effectiveness:  Harris Hip Score (HHS) 
- 
Effectiveness: Devane classification  
Note: Since patients with no complaints requiring an orthopedic opinion do not usually present for a 2-
year visit, only the functional questions of the 2-year HHS score will be collected during the telephone 
interview. 
 
4. DESCRIPTION OF THE STUDY 
The design of the study is: 
- 
Observational 
- 
Retrospective 
- 
Non-comparative 
- 
Not blinded  
- 
Monocentric 
- 
National 
This methodologic choice is linked to the search of current practice data, and to the small number of 
surgeons who have so far use SYMBOL CUP DMR HA or SYMBOL CUP DM CEM, on large 
consecutive series of patients, thus enabling sufficient consecutive patient recruitment, and who, 
moreover, maintain a standard medical file record at 2-year follow-up with all the classic endpoints.  
4.1. DESCRIPTION OF MEASURES TAKEN TO REDUCE AND AVOID BIAS 
Consecutive recruitment with provision of sampling frame data. 
 

 
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5. STUDY FEASABILITY 
The clinical research associate (CRA) delegated by the sponsor will make two or three visits to the 
investigational center:  
- 
An inclusion visit to confirm the investigator's adherence to the protocol and to define the 
procedures for extracting and transferring anonymized data from the electronic patient record 
management system. As this is a single-center study, this visit will take place before the protocol 
is submitted to the CNIL. 
- 
A visit to extract and transfer anonymized data from patient files, and to call patients to obtain 
their two-year follow-up data. On this occasion, patients will be informed that they may object 
to the inclusion of their information in this study. During this visit, the sponsor's clinical research 
associate will check that the data are consistent with the contents of the patient files. He/she will 
confirm the completeness of the cohort, with consecutive placement of dual-mobility acetabular 
implants. An anonymized list of all THA during the recruitment period will be obtained and 
checked to establish the sampling frame. This visit will take place at the start of the study. 
- 
An additional visit by the CRA, to obtain missing data and resolve discrepancies, will take place 
if necessary.   
 
6. RÉALISATION PRATIQUE DU PROTOCOLE. 
6.1. DEROULEMENT DES VISITES LIEES A L’ETUDE  
The clinical research associate (CRA) delegated by the sponsor will make two or three visits to the 
investigational center:  
- 
An inclusion visit to confirm the investigator's adherence to the protocol and to define the 
procedures for extracting and transferring anonymized data from the electronic patient record 
management system. As this is a single-center study, this visit will take place before the protocol 
is submitted to the CNIL. 
- 
A visit to extract and transfer anonymized data from patient files, and to call patients to obtain 
their two-year follow-up data. On this occasion, patients will be informed that they may object 
to the inclusion of their information in this study. During this visit, the sponsor's clinical research 
associate will check that the data are consistent with the contents of the patient files. He/she will 
confirm the completeness of the cohort, with consecutive placement of dual-mobility acetabular 
implants. An anonymized list of all THA during the recruitment period will be obtained and 
checked to establish the sampling frame. This visit will take place at the start of the study. 

 
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- 
An additional visit by the CRA, to obtain missing data and resolve discrepancies, will take place 
if necessary.   
In the event of death reported by the patient’s entourage without a date, the surgeon will question the 
civil registry of the patient’s commune of birth to obtain the date and cause of death. 
6.2. SUMMARY OF PATIENT FOLLOW-UP 
Patient follow-up is the surgeon’s current practice. The protocol does not require any follow-up 
modalities additional to usual practice. In the event of missing data, the surgeon or secretariat will repeat 
a telephone call to the patients concerned, as usual, to ask follow-up questions. In the event of death 
reported by the patient’s entourage without a date or explanation, the surgeon will question the civil 
registry of the patient’s commune of birth. 
6.3. DESCRIPTION OF THE GENERAL LOGISTICAL ORGANIZATION OF THE STUDY 
The registered protocol and the copy of the database will be produced in 3 copies:  
- 
The first to the investigator 
- 
The second to the sponsor 
- 
The third to the statistician.  
All exchanges will be made by written mail transfer and USB key with acknowledgement of receipt. 
Any question raised by the statistician will be forwarded to the sponsor, who will obtain the investigator 
answer.  
6.4. BIOLOGICAL SAMPLES AND ANALYSES 
Not applicable 
7. ELIGIBILITY CRITERIA 
7.1. INCLUSION CRITERIA 
Any patient operated by Dr. Estour who has undergone hip replacement surgery with SYMBOL CUP 
DMR HA or SYMBOL CUP CEM acetabular implant and having reach 2-year follow-up on March 01, 
2018.  
7.2. NON-INCLUSION CRITERIA  
Explicit refusal by the patient to allow data describing his pathology and treatment to be included in this 
study. 
Minor patients or patients under guardianship. 
 

 
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7.3. RECRUITMENT PROCEDURES  
As this study is retrospective, patients were recruiting during routine care prior to the drafting of 
protocol. 
8. RULES FOR STOPPING THE STUDY 
8.1. TERMINATION OF THE STUDY BY THE SPONSOR  
The sponsor may stop the study at any time, for the following reasons:  
 
- Major protocol violations, 
- In the event of a request to stop by authorities  
8.2. TERMINATION OF THE STUDY BY THE INVESTIGATOR  
The investigator may stop participating in the study with agreement of the sponsor. The reason for the 
discontinuation of the study must be duly explained.  
 
9. DATA COLLECTED  
The data is collected in the electronic patient record management system will be copied directly into a 
spreadsheet by the surgeon or on site by the CRA. 2-year follow-up data will be entered directly into the 
spreadsheet. The list of variables is in Annex 2.  
 
10. STATISTICAL CONSIDERATIONS 
10.1. 
NUMBER OF SUBJECTS TO BE INCLUDED  
The size of the cohort considered to be the minimum in light of studies carried out by other 
manufacturers is at least 20 with a follow-up of 2 years.  
10.2. 
DATA ANALYSIS – GENERAL INFORMATION: DESCRIPTIVE APPROACH 
- 
Descriptive statistics: preoperative, operative, postoperative 
- 
Tabulation of adverse events 
- 
Kaplan-Meier analysis of implant survival 
- 
Comparison tests of preoperative versus 1-year and 2-year postoperative efficacy scores.   
Tests will be performed with a two-side alpha risk of 5%. Confidence intervals will be at 95%. 
Continuous variables will be tested using Student's t-test. Categorial variables will be tested using Chi-
2 test. 

 
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No subgroup analysis is planned. 
No interim analysis is justified given the strict retrospective nature of the study. 
10.3. 
MAIN ANALYSIS 
Prothesis survival: Kaplan-Meier analysis. 
10.4. 
SECONDARY ANALYSES  
Subgroup analyses: Not applicable 
- 
Descriptive statistics 
- 
Continuous variables: Student's t-test or non-parametric tests in case of a breach of the 
conditions for applying parametric tests. 
- 
Categorial variables: Chi-2 test. 
10.5. 
SAMPLING FRAME  
The sampling frame, i.e. all patients operated by the same surgeon in the same institution, for total hip 
replacement, between the first and the last date of inclusion of patients in the SYMBOL CUP DMR HA 
or SYMBOL CUP DM CEM cohort, will be the subject of descriptive statistics.   
Analysis will focus on age at date of operation, BMI, type of prosthesis, 1st intention or revision (See 
Questions relating to the sampling frame Annex 2). 
Its characteristics will be compared to those of the cohort.  
10.6. 
METHOD FOR TAKING INTO ACCOUNT MISSING, UNUSED OR INVALID DATA  
As the statistical analysis is descriptive, it will be carried out « per protocol » and missing data will not 
be substituted by values derived from hypotheses. 
Visibly aberrant data that the investigator cannot obtain through the usual telephone follow-up will be 
excluded from the analysis.  
Adverse event or follow-up dates for which the day is missing will be substituted by the mid-month 
date.  
10.7. 
PERSON RESPONSIBLE FOR THE ANALYSIS 
DAOUD, Frédéric 
Biostatistician 
MEDEXTENS SARL 
75 rue de Lourmel, 75015 Paris 
Phone: 06 03 00 68 98 
Mail: fcdaoud@medextens.com 

 
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Software used: 
Data was analyzed in STATA 14.2 MP - Parallel Edition, 64-bit 
StataCorp 
4905 Lakeway Drive 
College Station, Texas 77845 USA 
2-core Stata perpetual license: 
Serial number:  501406000407 
Licence de Medextens SARL 
 
11. ACCESS RIGHTS TO SOURCE DATA AND DOCUMENTS 
11.1. 
DATA ACCESS 
The sponsor is responsible for obtaining the agreement of all parties involved in the study to guarantee 
direct access to all research sites, source data, source documents and reports for the purposes of quality 
control and audit by the sponsor. 
Investigators will make available documents and individual data strictly necessary for the monitoring, 
quality control and auditing of biomedical research to persons with access to these documents in 
accordance with the legislative and regulatory provisions in force (articles L.1121-3 and R.5121-13 of 
the French Public Health Code). 
11.2. 
SOURCE DATA 
Any original document or object that can be used to prove the existence or accuracy of a data item or 
fact recorded during the course of the research is defined as a source document. 
The source data is exclusively the patient file located in the clinic where the patients included in the 
study were operated on, and under the responsibility of the surgeon. 
The sponsor’s CRA will be not able to obtain a copy of source data but may ask to check them to ensure 
the accuracy of the final database.  
11.3. 
DATA PRIVACY 
In accordance with current legislation (articles L.1121-3 and R.5121-13 of the French Public Health 
Code), persons with direct access to source data must take all necessary precautions to ensure the 
confidentiality of information relating to investigational medicinal products, research, the persons 

 
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involved, and in particular their identity, as well as the results obtained. These persons, like the 
investigators themselves, are bound by professional confidentiality. 
 
During biomedical research or at its termination, the data collected on the persons involved and 
transmitted to the sponsor by the doctors (or any other specialist) will be rendered anonymous. Under 
no circumstances may the names or addresses of the persons concerned should appear in clear text. 
 
Patients will be coded by serial number. No initials will be recorded. Identification by the surgeon will 
be by month/year of birth, gender and date of surgery. 
Source data form an integral part of the patient file. 
The spreadsheet with extracted data sent to the sponsor wil be kept for 30 years after the medical device 
is withdrawn from the market. 
The copy held by the statistician with the statistician scripts and data tables will be deleted by him from 
his company’s computer as soon as the study report has been signed and submitted.  
 
12. ETHICAL CONSIDERATIONS 
12.1. 
INDEPENDENT ETHICS COMMITTEE 
Not applicable 
12.2. 
PATIENT INFORMATION  
Patients will be fully and fairly informed, in comprehensible terms, of the objectives of the study and 
the nature of the information collected, and of their right to object at any time to the use of the data 
collected. All this information is conveyed orally to patients by the surgeon. This oral information is 
completed by an information note given to each patient. Finally, general information on research 
activities is displayed at the Médipôle de Savoie Hospital. 
 
12.3. 
SUPPORT FOR STUDY 
This is a retrospective observational cohort study, whose only workload is the extraction of data from 
patient files. The cost of this work will be covered by the contract between the sponsor and the 
investigator once it has been approved by the CNOM.   

 
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13. DATA PROCESSING AND STORAGE OF DOCUMENTS AND DATA 
RELATING TO THE STUDY 
13.1. 
DATA ENTRY AND PROCESSING  
The data will be extracted into a spreadsheet by the investigator himself or his team in the institution. 
Analysis will be carried out by Frederic DAOUD See paragraph 10.7.   
13.2. 
CNIL 
This is a retrospective, single-center observational study. Thus, the study complies with the Reference 
Methodology MR003 and has been declared to the CNIL1.  
13.3. 
ARCHIVING 
The archiving of the documents mentioned below is the responsibility of DEDIENNE SANTE SAS. 
The documentation will be archived for a period of 30 years following withdrawal of the product from 
the market as defined in quality procedure PRO_QUAL_001. 
These documents are:  
• 
Protocol et annexes, any amendments 
• 
Information forms  
• 
Database transferred by the investigator  
• 
Follow-up documents 
• 
Statistical report and any files used to produce the report 
• 
Final study report 
No displacement or destruction may be carried out without the agreement of the sponsor. At the end of 
the 30 years, the sponsor will be consulted for destruction. All data, documents and reports may be 
subject to audit or inspection. 
14. COMMUNICATION – PUBLICATION RULES 
Data will only be disclosed with the prior joint agreement of the investigator and the sponsor. The results 
may be communicated and published.  
 
1 Official text: Deliberation no. 2016-263 of 21 July 2016 approving a reference methodology for the processing of 
personal data implemented in the context of research in the field of health that does not require the express or written 
consent of the data subject (MR-003). 
Website consulted:  
https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000033028290&dateTexte=&categorieLien=id 

 
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15. INVESTIGATOR CONTRACT  
See Annex 5 
 
16. LIST OF ANNEXES 
Annex 1: Copy of CE mark and generic reimbursement code applicable to the patients included in the 
study  
Annex 2: List of study variables 
Annex 3: Information note and collection of non-opposition form 
Annex 4: CNIL registration 
Annex 5: Investigator contract  
 
17. ASSOCIATED DOCUMENTS  
Information note  
 
 
 
 
 
 

 
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Annex 1: Copy of CE mark and generic reimbursement code applicable to the patients included 
in the study. 
 
These products are currently supported under the following generic descriptions: 
- SYMBOL CUP DM CEM: 3150450 – hip, standard cup, modular, metal-back, without insert, 
cemented  
- SYMBOL CUP DMR HA: 3168042 - hip, reconstruction cup, modular, metal-back, without insert, 
uncemented 
- DUAL MOBILITY PE LINER: 3161130 – hip, solid polymer insert 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Annex 2: List of study variables 
 
DATA FROM THE COHORT SYMBOL CUP DMR HA AND SYMBOL CUP DM CEM 
PREOPERATIVE DEMOGRAPHICS 
Order number of the surgery with this type of implant 
Type of implant DMR HA or CEM 
Month/year of birth 
Sex 
Surgeon identification  
Date of preoperative visit  
Height (cm) 
Weight (Kg) 
BMI 
BMI class  
Operated side 
Etiology / diagnosis 
Medication 
Medication - Specify 
Medical history 
Medical history - Specify 
Local surgical history on the affected hip  
Local surgical history on the affected hip - Specify 
Surgeon’s comments 
PREOPERATIVE 
DEVANE & CHARNLEY 
CLASSIFICATIONS 
DEVANE 
CHARNLEY 
HHS PAIN 
Pain 
HHS FUNCTIONAL ABILITIES - 
WALKING 
Lameness 
Support 
Walking perimeter 
HHS FUNCTIONAL ABILITIES – 
DAILY LIFE 
Socks and shoes  
Stairs  
Sitting position  
Public transport  
HHS – MOBILITY  
Flexion ° 
Extension ° 
Abduction ° 
Adduction ° 
External rotation ° 

 
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Internal rotation ° 
TOTAL MOBILITY 
DEFORMATIONS 
LLI (cm) 
Flessum ° 
Adductum ° 
Internal rotation ° 
TOTAL DEFORMATIONS 
TOTAL PREOPERATIVE HHS  
SURGICAL INTERVENTION  
Date of surgery 
Age at surgery 
Intervention duration (min) 
Surgical approach 
Type of intervention 
Surgeon’s comments 
Operative adverse events  
ACETABULAR COMPONENTS 
Cup walls 
Fragile acetabulum zone 
Cup identification   
Size  
Cement 
Reaming diameter 
Liner 
Femoral head  
Diameter 
Bone graft 
Screw 
Pegs 
Associated surgical procedure 
FEMORAL STEM  
Stem identification  
Cement 
CCD angle 
Collar 
Broach size  
Stem size  
Neck length  
Bone graft  
STABILITY 
Stability of the hip  
INCIDENTS 
Operative adverse events  
SURGEON’S COMMENTS – END OF 
SURGERY 
Surgeon’s comments  
1-year postoperative assessment  
Date  
Death  

 
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Reason for death  
1-year postoperative assessment 
DEVANE & CHARNLEY 
CLASSIFICATIONS  
DEVANE 
CHARNLEY 
HHS PAIN  
Pain  
HHS FUNCTIONAL ABILITIES - 
WALKING 
Lameness 
Support 
Walking perimeter 
HHS FUNCTIONAL ABILITIES – 
DAILY LIFE 
Socks and shoes  
Stairs  
Sitting position  
Public transport  
HHS – MOBILITY  
Flexion ° 
Extension ° 
Abduction ° 
Adduction ° 
External rotation ° 
Internal rotation ° 
TOTAL MOBILITY 
DEFORMATIONS 
LLI (cm) 
Flessum ° 
Adductum ° 
Internal rotation ° 
TOTAL DEFORMATIONS 
TOTAL 1-YEAR FU HHS  
Adverse events and reason 
Adverse events at 1-year FU 
Date of occurrence of the adverse event  
Potential reason  
Treatment  
Without revision surgery  
Surgical revision without component revision  
Surgical revision with revision of components  
Date of revision surgery  
Adverse event solved Yes/No   
Unsolved adverse event – reason  
Radiologic assessment at 1 year  
Global offset  
Global length  
Cup 
Cup inclination  
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Profile stem 
Surgeon’s comments 
2-year postoperative assessment  
Date of telephone interview 
 
Death  
Reason for death  
2-year postoperative assessment 
DEVANE & CHARNLEY 
CLASSIFICATIONS  
DEVANE 
CHARNLEY 
HHS PAIN  
Pain  
HHS FUNCTIONAL ABILITIES - 
WALKING 
Lameness 
Support 
Walking perimeter 
HHS FUNCTIONAL ABILITIES – 
DAILY LIFE 
Socks and shoes  
Stairs  
Sitting position  
Public transport  
HHS FUNCTIONAL ABILITIES TOTAL HHS FUNCTIONAL ABILITIES TOTAL AT 2-YEAR FU 
Adverse events and reason 
Adverse events at 2-year FU 
Date of occurrence of the adverse event  
Potential reason  
Treatment  
Without revision surgery  
Surgical revision without component revision  
Surgical revision with revision of components  
Date of revision surgery  
Adverse event solved Yes/No   
Unsolved adverse event – reason  
 
 
 

 
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SAMPLING FRAME DATA  
Patient number  
Month/year of birth  
Sex 
Weight  
Height  
BMI 
Date of surgery  
Age at surgery  
Type of intervention (first intention THA or revision THA) 
Type of dual mobility acetabular implant (SYMBOL CUP DMR HA or SYMBOL CUP DM CEM) 
Single or dual mobility  
 
 
 

 
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Annex 3. Information note  

 
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Annex 4. CNIL registration  

 
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Annex 5. Investigator contract  

 
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18. BIBLIOGRAPHY 
 
 
i Avis de la CNEDIMTS du 18 novembre 2014 relatif à la phase contradictoire des prothèses de hanche. HAS, 2014. 
ii Déclaration CE de conformité du 09 avril 2014. 
iii Attestation CE – N°27262 rev. 5 du 1er septembre 2015. LNE, Organisme notifié n°0459. Cotyles Double mobilité 
sans ciment et à cimenter. SYMBOL CUP DM, GMDN code 43167-43168. 
iv Evaluation clinique «Cotyles de hanche, double mobilité, SYMBOL CUP DM » du 28/11/2013 réalisée par 
Dedienne Santé, mis à jour le 28/11/2014 
v LNE G-MED. Revue et évaluation du rapport d’évaluation clinique. Evaluation initiale. DEDIENNE SANTE, DM : 
Cotyle double mobilité SYMBOL CUP DM, N° dossier : P122250. Rapport eval clinique DEDIENNE cotyle 2M 
SYMBOL 140214.pdf.