Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
Conditions: Hip Arthropathy
Sponsor: Societe dEtude, de Recherche et de Fabrication

 
Clinical Investigation Plan 
 
21/12/2022  
Version 1.2 – 2022-10-Sagitta-EVL-R_PIC 
 
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FR-CLI-019 – Ind.02 – Date Application : 31/03/2022 
 
 
 
 
 
 
 
Official title : 
Etude ambispective évaluant les résultats cliniques des tiges de révision SAGITTA EVL R 
 
NCT number: 
NCT06096168 
 
Document date:  
21/12/2022 
 
 
 
 
 
(Translation of protocol approved on 17/02/2023 by human subjects review board “Comité de 
Protection des Personnes Nord Ouest IV”) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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FR-CLI-019 – Ind.02 – Date of application: 31/03/2022 
CLINICAL INVESTIGATION PLAN 
"AMBISPECTIVE STUDY EVALUATING THE CLINICAL OUTCOMES OF 
SAGITTA EVL-R REVISION STEM" 
"2022-10_SAGITTA-EVL-R " 
Identification 
RCB-ID Number: 2022-A02295-38 
Protocol reference: 2022-10_Sagitta-EVL-R 
Date: 21/12/2022 
Version: 1.2 
Protocol Amendment Number: N/A 
Date: N/A 
Promoter 
Name of the Promoter: SERF 
Address: 85 Avenue de Bruyères, 69150 Décines-Charpieu- FRANCE 
Phone: +33 (0)4.72.05.60.10 
Privacy Statement 
The information contained in this document is confidential. Their dissemination, copying or disclosure 
is strictly forbidden except at the request of agents of the legal authorities. Persons to whom the 
information is communicated must be warned that the information is confidential and that they may not 
disclose it. 

 
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Stakeholders 
Principal investigator 
Name: Prof. DUJARDIN Franck 
Title/Position: Orthopaedic Surgeon 
Establishment: Rouen University Hospital – Charles Nicolle Hospital 
Address: 37 Bd Gambetta, 76000 Rouen 
Tel: 0232888007 
 
 
/ Mail: franck.dujardin@chu-rouen.fr 
 
 
 
History of amendments 
Date: N/A 
Version: N/A 
Description:  
Not applicable – initial version  
 
 

 
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PROTOCOL SIGNATURE PAGE 
"Ambispective Study Evaluating the Clinical Outcomes of SAGITTA EVL R  
Revision Stem" 
 
Protocol Number: "2022-10" 
"Version 1.2" of "21/12/2022" 
 
Legal representative of the Promoter 
Signature 
Name: Lydie BONNEVAY 
 
Title: Clinical Project Manager 
Date: 
 
Visa: 
 
 
 
Name: Jean-Charles MONCENIS 
 
Title: Regulatory and Clinical Affairs Manager 
Date: 
 
Visa: 
 
 
 
 
 
Principal Investigator 
Signature 
I have read all the pages of the protocol of study N° "2022-10" dated 21/12/2022 and all its annexes 
and validate its content. I confirm that it contains all the information necessary to conduct the study. I 
undertake to conduct the study in accordance with the protocol and the terms and conditions set out 
therein. 
Name: DUJARDIN Franck 
 
Centre: Rouen University Hospital – Charles Nicolle Hospital 
Date: 22/12/2022 
 
Visa: 
          
 
 
 
 

 
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Table of Contents 
LIST OF ABBREVIATIONS ................................................................................................................ 9 
1. GENERAL SYNOPSIS OF THE CLINICAL INVESTIGATION .......................................... 10 
2. IDENTIFICATION AND DESCRIPTION OF THE DEVICE UNDER INVESTIGATION
 ........................................................................................................................................................... 13 
Has. 
Description and intended use 
13 
B. 
Maker 
13 
C. 
Device under investigation 
13 
D. 
Traceability 
15 
E. 
Intended objective of the device in the investigation 
15 
F. 
Populations and Indications, contraindications of use for which the device under 
investigation is intended 
15 
i. 
Indicated Population(s) for the Device ............................................................................ 15 
Ii. 
Directions ............................................................................................................................... 15 
Iii. 
Contraindications ................................................................................................................. 15 
G. 
Prerequisites for use 
15 
i. 
Education and experience needed ................................................................................... 15 
Ii. 
Application-Specific Procedures ........................................................................................ 16 
3. CI DESIGN RATIONALE ............................................................................................................ 16 
Has. 
Evaluation of the results of the relevant preclinical evaluation performed to justify 
the use of the device on human subjects 
16 
B. 
Evaluation of clinical data related to the proposed HF 
16 
C. 
Clinical development stage 
16 
4. RISKS AND BENEFITS OF THE DEVICE AND THE CI ..................................................... 16 
Has. 
Expected clinical benefits 
16 
B. 
Expected adverse reactions 
17 
C. 
Associated residual risks as identified in the risk analysis report 
17 
D. 
Risks associated with participation in the IC 
18 
E. 
Possible interactions with concomitant medical treatments 
18 
F. 
Studies undertaken to control or mitigate risks 
18 
G. 
Rationale for the benefit/risk balance 
18 
5. CI OBJECTIVES AND ASSUMPTIONS ................................................................................... 18 
Has. 
Claims and Planned Performance That Need to Be Verified 
18 
B. 
Expected risks and adverse effects that need to be assessed 
19 
C. 
Main and secondary objectives 
19 
i. 
Main objective ....................................................................................................................... 19 
Ii. 
Secondary Objectives ......................................................................................................... 19 
D. 
Primary and secondary assumptions to be rejected or accepted based on CI 
statistical data 
19 
E. 
Justification of parameters and assumptions 
19 

 
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6. CLINICAL INVESTIGATION DESIGN ................................................................................... 19 
Has. 
GENERAL 
19 
i. 
Description of the Type of HF ............................................................................................ 19 
Ii. 
Limitations of bias ................................................................................................................ 19 
Iii. 
Primary and secondary outcomes .................................................................................... 20 
Iv. 
Methods and timing of evaluation, recording and analysis of variables .................. 23 
v. 
Equipment to be used to evaluate CI variables and provisions for maintenance and 
calibration monitoring ...................................................................................................................... 23 
Vi. 
Procedures for replacing subjects, if applicable ............................................................ 23 
Vii. 
Investigation site(s) ............................................................................................................ 24 
Viii. 
End of CI ................................................................................................................................ 24 
B. 
Device(s) under investigation and comparator(s) 
24 
i. 
Description of exposure to the device(s) under investigation or comparator(s) ... 24 
Ii. 
List of any other medical devices or drugs to be used during HF that are not already 
listed in the instructions for use .................................................................................................... 24 
Iii. 
Number of devices under investigation to be used ...................................................... 24 
C. 
Topics 
24 
i. 
Inclusion criteria................................................................................................................... 24 
Ii. 
Criteria for non-inclusion .................................................................................................... 24 
Iii. 
Criteria for Subject's Exclusion ......................................................................................... 25 
Iv. 
Criteria and procedures for withdrawing a subject, discontinuing participation or 
losing sight of a subject .................................................................................................................. 25 
v. 
Time of enlistment ............................................................................................................... 25 
Vi. 
Timing of Randomization .................................................................................................... 25 
Vii. 
Expected duration of participation of each topic ........................................................... 25 
Viii. 
Number of required topics to be included in the CI ..................................................... 25 
Ix. 
Inclusion period .................................................................................................................... 25 
x. 
Total expected duration of CI ............................................................................................ 25 
xi. 
Relationship between the study population and the target population ................... 25 
Xii. 
Vulnerable populations, pregnant and/or breastfeeding women .............................. 26 
D. 
Procedures 
26 
i. 
Description of any HF-related procedures to which subjects are subjected (including 
deviations from standard care) ..................................................................................................... 26 
Ii. 
Description of activities carried out by the Proponent's representatives (excluding 
monitoring) ........................................................................................................................................ 27 
Iii. 
Any known or foreseeable factors that may affect the effects or interpretation of the 
results 27 

 
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E. 
Monitoring plan 
27 
7. STATISTICAL CONSIDERATIONS ......................................................................................... 28 
Has. 
Data analysis 
28 
B. 
Data description 
28 
C. 
Analytical procedures 
28 
i. 
Calculation of confidence intervals ................................................................................... 28 
Ii. 
ii. Calculation of the revision rate .................................................................................... 29 
Iii. 
Calculation of the survival rate ......................................................................................... 29 
D. 
degrees of significance and strength of the CI 
29 
E. 
Sample size 
30 
F. 
Learning curve and data consideration 
30 
G. 
HF Pass/Fail Criteria 
30 
H. 
Interim analyses and discontinuation of CI from a statistical point of view 
30 
i. 
Interim analyses .................................................................................................................. 30 
Ii. 
Cessation of HF based on statistical criteria .................................................................. 30 
I. 
Accounting for biases 
30 
i. 
Statistical bias ...................................................................................................................... 30 
Ii. 
Confounding factors ............................................................................................................ 30 
Iii. 
Specifying Subgroups for Analysis ................................................................................... 30 
Iv. 
Checking and adjusting error probabilities ..................................................................... 31 
J. 
Handling missing, unused or erroneous data, including abandonments and 
withdrawals 
31 
i. 
Data Inclusion Methodology .............................................................................................. 31 
Ii. 
Exploratory and sensitivity analyses ............................................................................... 31 
K. 
Procedures for reporting any deviations from the original statistical plan 
31 
L. 
In the case of multicentre investigations, minimum and maximum number of 
subjects to be included for each centre 
31 
8. DATA MANAGEMENT .................................................................................................................. 31 
Has. 
Data Entry and Collection Methods 
31 
B. 
Procedures for examining data, cleaning up databases, and issuing and resolving 
data queries 
32 
C. 
Procedures for verifying, validating and securing electronic clinical data systems
 
32 
i. 
General ................................................................................................................................... 32 
Ii. 
Specific ................................................................................................................................... 32 
D. 
Maintaining confidentiality and respecting the privacy of subjects 
32 
E. 
Data Retention 
32 
F. 
Retention period 
33 
G. 
Other aspects of clinical quality assurance 
33 
9. AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN ........................................... 33 

 
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10. DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN ....................................... 33 
Has. 
Statement that the investigator is not authorized to deviate from the ICP 
33 
B. 
Procedure for recording, reporting and gap analysis in relation to the CIP 
33 
C. 
Notification requirements and deadlines 
34 
D. 
Corrective and preventive actions and criteria for disqualification of the principal 
investigator 
34 
11. DEVICE ACCOUNTING ............................................................................................................... 34 
Has. 
Accounting procedure 
34 
B. 
Procedures and instructions for the return of potentially hazardous devices 
34 
12. DECLARATION OF CONFORMITY .......................................................................................... 34 
Has. 
Declaration of Helsinki 
34 
B. 
Compliance with ISO 14155 NF and national and/or regional regulations 
35 
C. 
Approvals/Favourable Opinions Required 
35 
D. 
Additional Requirements 
35 
E. 
Insurance 
35 
F. 
Investigative funding 
35 
13. PROCESS FOR OBTAINING NON-OPPOSITION ............................................................... 35 
Has. 
General process for obtaining informed consent 
35 
B. 
Special cases 
36 
14. ADVERSE EVENTS, ADVERSE DEVICE REACTIONS, AND DEVICE DEFECTS ......... 36 
Has. 
Definitions of adverse events and adverse reactions to the device 
36 
B. 
Definition of defects and malfunctions of the device 
37 
C. 
Events, serious adverse reactions, serious adverse reactions to the device, serious 
unexpected adverse reactions to the device, public health threats 
37 
D. 
List of undesirable reactions that may not be reported 
37 
E. 
Reporting Deadlines 
38 
F. 
Details of the Adverse Event Reporting Process 
38 
G. 
Details of the Device Defect Reporting Process 
39 
H. 
List of foreseeable adverse events and expected adverse reactions of the device
 
39 
I. 
Emergency contact information 
39 
J. 
Information related to the data monitoring committee if established 
39 
15. VULNERABLE POPULATION .................................................................................................... 39 
Has. 
Description of the vulnerable population to be included 
39 
B. 
Description of the screening process to identify and protect vulnerable populations
 
39 
C. 
Description of the specific process for obtaining informed consent 
40 
D. 
Description of the specific responsibility of the Ethics Committee 
40 
E. 
Description of any medical care provided to subjects after HF is completed 
40 
16. PREMATURE TERMINATION OR SUSPENSION OF THE CI .......................................... 40 
Has. 
Criteria and provisions for premature termination or suspension of clinical 
investigation for the entire investigation or for one or more sites 
40 
i. 
For the entire investigation ................................................................................................ 40 

 
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Ii. 
For one or more centres ..................................................................................................... 40 
B. 
Criteria for Setting Up and Breaking the Blinding Code Due to Suspension or Early 
Termination of IC 
40 
C. 
Subject Tracking Requirement 
40 
17. PUBLICATION POLICY .............................................................................................................. 41 
Has. 
Registration of the study in a publicly available database 
41 
B. 
Statement that the results will be publicly available 
41 
C. 
Statement of the conditions under which CI results will be published 
41 
18. BIBLIOGRAPHY ........................................................................................................................... 41 
Appendix 1: List and qualifications of investigators .......................................................... 42 
Appendix 2: Product Instruction Leaflet under review ..................................................... 43 
Appendix 3: Information Letter on ............................................................................................ 44 
Appendix 4: SRIA-CIDT Reporting Form ................................................................................. 45 
Appendix 5: Harris Hip Score ....................................................................................................... 46 
Appendix 6: Forgotten Hip Score – SHO12 ............................................................................. 48 
Appendix 7: Engh Score ................................................................................................................. 49 
 
 
 

 
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LIST OF ABBREVIATIONS 
 
ANSM 
National Agency for the Safety of Medicines and Health Products 
BOW 
Clinical Research Associate 
PCBs 
Good Clinical Practice 
CNIL 
National Commission "Information Technology and Freedoms" 
CPP 
Committee for the Protection of Persons  
CRF 
Case Report Form 
Eff.In 
Adverse effect  
EI 
Adverse event 
EIG 
Serious Adverse Event 
EII 
Unexpected adverse reaction 
EIGD 
Serious adverse reaction to the medical device 
EIGID 
Unexpected serious adverse reaction from the medical device 
IC 
Clinical Investigation 
MR 
Reference Methodology 
WOODPECKE
R 
Clinical Investigation Plan  
PTH 
Total Hip Replacement 
 
 
 
 
 

 
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1. GENERAL SYNOPSIS OF THE CLINICAL INVESTIGATION 
Title  
Ambispective study evaluating the clinical outcomes of revision stem 
SAGITTA EVL R 
ID-RCB No.  
Protocol version 
Date 
2022-A02295-38 
V1.2 
21/12/2022 
Promoter 
SERF 
85 Avenue des Bruyères 
69150 Décines-Charpieu 
FRANCE 
Principal investigator 
Prof. DUJARDIN Franck 
Rationale/Background 
This clinical study is being conducted with the aim of collecting data on hip arthroplasty 
with revision femoral stems from the SAGITTA® EVL-R  range of FEMORAL stems 
manufactured by SERF. In order to reflect current practice, a comprehensive and 
ongoing series of patients will be included. 
This study will confirm the performance and safety of  the SAGITTA® EVL R  range of 
revision femoral stems within the MDR 2017/745 regulatory framework and in relation 
to the recommendations of the MEDDEV 2.7.1 guide. Rev 4 (Clinical Evaluation 
Guide), which provides for the implementation of a systematic procedure for monitoring 
clinical data in order to verify the claimed performance of medical devices. 
Product 
under 
investigation 
SAGITTA® EVL R revision femoral stems and CLAV distal locking keys. EVL. 
Methodology 
Post-marketing clinical follow-up study performed according to routine care with 
additional procedure neither heavy nor invasive, non-interventional ambispective, 
monocentric, non-comparative, open-label, of an exhaustive and continuous series of 
patients. 
Ethical considerations 
The investigation will be conducted in accordance with the investigation protocol, the 
regulations in force, including the Public Health Code as well as the Medical Devices 
Regulation 2017/745, the ISO 14155:2020 standard, as well as in accordance with the 
ethical principles described in the Declaration of Helsinki. 
The investigation will start as soon as the authorisations from the competent authorities 
are received in accordance with the typology of the study, category 4.1. 
As personal data will be collected and analysed during this investigation, SERF 
complies with the reference methodology MR 001 (declaration 2140288 v 0). The 
collection of personal data will also be in accordance with GDPR 2016/679. 
All data and information relating to patients or their participation in this study will be 
considered confidential and in accordance with applicable laws and regulations will not 
be made public. 
The data collected and stored in a pseudonymised format does not allow the 
identification of a patient through the data collected. Under no circumstances will the 
names of patients be transmitted or communicated to SERF. 

 
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Patient consent will be collected by the principal investigator or another surgeon in the 
department during the on-site follow-up visit. 
As the EUDAMED database is not yet available, this study will be registered on the 
public database www.clinicaltrials.gov. 
Main objective 
To evaluate the medium-term postoperative survival rate (minimum 4 years 
postoperatively) of SAGITTA® EVL R rods placed between 2016 and 2018, all causes 
of revision combined. 
Secondary objective(s) 
The secondary objectives of this study are to:  
- Study the survival rate by components and by etiology (revision and revision with 
reconstruction) 
- Study the patient's satisfaction with his hip prosthesis 
- Confirm the safety of these implants by studying any complications observed 
- Evaluate performance through the clinical scores of HARRIS and forgotten 
prosthesis score of the revision femoral stems SAGITTA® EVL R. 
Primary outcome 
The survival rate will be determined according to the Kaplan-Meier curve with the 
replacement of the femoral implant, all causes combined. 
Secondary outcome(s)  
The survival rate by component as well as the survival rate by etiology will be 
determined according to the Kaplan-Meier all-cause curve. 
 
The safety of the implants will be evaluated by the occurrence of adverse events 
related to the medical device. These elements will be sought by the clinical examination 
of the practitioner and the radiological examination, carried out as part of routine 
practice. 
 
Patient satisfaction with  their hip replacement will be assessed using a satisfaction 
questionnaire. 
 
Implant performance will be assessed through the Harris Clinical Hip Score (HHS) 
and Forgotten Hip Score (SHO-12).  
Description of the study 
population 
Between January 2016 and December 2018, about 120 patients were operated on with 
a SAGITTA® EVL R revision  femoral stem at the Rouen University Hospital – Charles 
Nicolle Hospital. All patients with a SAGITTA® EVL R revision  femoral stem will be 
seen again at a medium-term postoperative follow-up visit (minimum 4 years 
postoperatively). During this follow-up, they will be offered to participate in this clinical 
investigation. 
Criteria for Inclusion of 
Subjects 
- Patient of legal age on the date of surgery, 
- Patient implanted with a SAGITTA® EVL R  revision femoral stem as part of its 
indications between 01/01/2016 and 31/12/2018, 
- Patient with a health insurance scheme 
Criteria for non-inclusion 
of subjects 
- Patient who has not expressed consent to the collection of his/her data and 
participation in the study, 
- Patient unable to understand the surgeon's instructions or perform postoperative 
follow-up. 

 
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- Patient with a contraindication to the use of the SAGITTA® EVL R revision femoral 
stem 
- Patient implanted with a SAGITTA® EVL R revision femoral stem outside of their 
indication 
Number of Subjects 
As the study is descriptive, there is no calculation of the number of subjects needed 
according to a hypothesis. All patients operated on at the Rouen University Hospital – 
Charles Nicolle Hospital and with a SAGITTA® EVL R  femoral stem will be included. 
This represents about 120 patients. 
Treatment(s)/procedure(s
) related to the study 
Prospective part:  
According to the centre's practice, as part of the systematic follow-up of hip 
replacement replacements, a clinical examination will be carried out with an 
assessment of any complications and patient satisfaction. Only a quality of life 
questionnaire (SHO-12) and the HHS score will be required by this HF in addition to 
the standard care practiced in systematic follow-up in this center. These questionnaires 
will be completed jointly by the patients and the surgeon (additional procedure that is 
neither heavy nor invasive). 
Routine radiological evaluation will be performed. It allows the evaluation of 
osseointegration and bone reconstruction to document possible complications. 
The collection of its data will be carried out in a paper case report form (CRF). 
Retrospective part:  
In accordance with the patient's agreement, retrospective data will be collected using 
the patient's medical record and will be collected in the CRF. 
No additional examination to current practice will be carried out as part of this 
investigation. 
Total duration of the study 
The prospective portion of the study will last approximately 5 months depending on 
patient availability. The duration of each patient's participation in this study is limited to 
this single consultation. 
Retrospective data collection will be carried out simultaneously. 
This is a total duration of the study of 5 months. 
Study timeline 
The prospective part will begin as soon as regulatory approvals are obtained, 
scheduled for January 2023 and will be completed in May 2023. 
The retrospective part will be conducted after the patient consent has been collected. 
Study closure and report writing: July 2023 
Statistical analysis 
A statistical analysis will be carried out at the end of the study. This analysis will be 
carried out by SERF. A descriptive analysis will be done based on the data collected 
during the study. A follow-up of the events that occurred will be carried out, as well as 
an analysis of the survival rate according to Kaplan Meier. 
 
 

 
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2. IDENTIFICATION AND DESCRIPTION OF THE DEVICE 
UNDER INVESTIGATION 
A. DESCRIPTION AND INTENDED USE 
The devices under investigation in this clinical investigation (CI) are the SAGITTA® EVL R  revision rods, 
the fixation of which can be completed by the use of two CLAV distal locking keys. EVL.  
The SAGITTA® EVL R femoral stem range, in combination with the prosthetic heads and two optional 
distal locking keys, is suitable for most femoral revisions of total hip prosthesis (THP) with bone defect 
(Paprosky type I to III and SOFCOT stage II to IV) in order to reduce pain and restore mobility of the hip 
joint.  
B. MAKER 
 
 
 
85 avenue des Bruyères 
69150 DECINES-CHARPIEU - FRANCE 
Tel. 04 72 05 60 10 
Fax. 04 72 02 19 18 
E-mail: serf@serf.fr 
C.  DEVICE UNDER INVESTIGATION 
Revision femoral stems SAGITTA® EVL R (Figure 1) are long, uncemented stems. 
They are made of forged TA6V alloy (ISO 5832-3 compliant). They have a 
hydroxyapatite coating (compliant with 13779-2) along the entire implantable length 
of the stem.  
The curved distal part takes up the anatomical arch. The cervico-diaphyseal angle is 
130°. The 11/13 assembly cone has an average angle of 4°.  
The SAGITTA® EVL R rod range consists of 14 rods on the right side and 14 rods 
on the left side, with 3 different rod lengths for each side (180 mm, 250 mm or 325 
mm). 
The attachment of the revision rod can be completed with 2 transcortical locking keys 
made of titanium (Figure 1) TA6V (ISO 5832-3). With a diameter of 4.5 mm, they are 
available in 9 lengths: 25; 30 ; 35 ; 40 ; 45 ; 50 ; 55 ; 60 and 65 mm. 
 
 
 
 
The rod references ( 
Table 1) and keys (Table 2) used in this CI are set out below: 
 
 
 
Table 1 – Lengths, sizes, diameters, labels and references of the rods SAGITTA® EVL R 
 
Figure 1 - At the top, a revision femoral stem SAGITTA® EVL R; at the bottom, a distal locking key 
CLAV. EVL 

 
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Length 
Waist 
∅ 
(mm) 
Right Side 
Left side 
Wording 
Reference 
Wording 
Reference 
180 mm 
2 
12 
SAGIT. EVL R 2-180 D 
RM10450500 
SAGIT. EVL R 2-180 G 
RM10450520 
3 
13 
SAGIT. EVL R 3-180 D 
RM10450501 
SAGIT. EVL R 3-180 G 
RM10450521 
4 
14 
SAGIT. EVL R 4-180 D 
RM10450502 
SAGIT. EVL R 4-180 G 
RM10450522 
5 
15 
SAGIT. EVL R 5-180 D 
RM10450503 
SAGIT. EVL R 5-180 G 
RM10450523 
6 
16 
SAGIT. EVL R 6-180 D 
RM10450504 
SAGIT. EVL R 6-180 G 
RM10450524 
250 mm 
2 
12 
SAGIT. EVL R 2-250 D 
RM10450505 
SAGIT. EVL R 2-250 G 
RM10450525 
3 
13 
SAGIT. EVL R 3-250 D 
RM10450506 
SAGIT. EVL R 3-250 G 
RM10450526 
4 
14 
SAGIT. EVL R 4-250 D 
RM10450507 
SAGIT. EVL R 4-250 G 
RM10450527 
5 
15 
SAGIT. EVL R 5-250 D 
RM10450508 
SAGIT. EVL R 5-250 G 
RM10450528 
6 
16 
SAGIT. EVL R 6-250 D 
RM10450509 
SAGIT. EVL R 6-250 G 
RM10450529 
325 mm 
3 
13 
SAGIT. EVL R 3-325 D 
RM10450510 
SAGIT. EVL R 3-325 G 
RM10450530 
4 
14 
SAGIT. EVL R 4-325 D 
RM10450511 
SAGIT. EVL R 4-325 G 
RM10450531 
5 
15 
SAGIT. EVL R 5-325 D 
RM10450512 
SAGIT. EVL R 5-325 G 
RM10450532 
6 
16 
SAGIT. EVL R 6-325 D 
RM10450513 
SAGIT. EVL R 6-325 G 
RM10450533 
 
 
Table 2 - Lengths, diameter, labels and references of the optional CLAV distal locking keys. EVL 
Length 
∅ 
Wording 
Reference 
25 mm 
4.5 mm 
CLAV. EVL 25 
RM69020020 
30 mm 
CLAV. EVL 30 
RM69020021 
35 mm 
CLAV. EVL 35 
RM69020022 
40 mm 
CLAV. EVL 40 
RM69020023 
45 mm 
CLAV. EVL 45 
RM69020024 
50 mm 
CLAV. EVL 50 
RM69020025 
55 mm 
CLAV. EVL 55 
RM69020026 
60 mm 
CLAV. EVL 60 
RM69020027 
65 mm 
CLAV. EVL 65 
RM69020028 
 
The stems SAGITTA® EVL R as well as the CLAV keys. EVLs are long-term implantable medical devices 
that are invasive, sterile, non-active and do not contain drugs or biologically active substances (tissues of 
human or animal origin, or their derivatives), their regulatory description is available in the Table 3. 
 
 
Table 3 - Regulatory description of products under investigation 
 
Device 
Class 
Code GMDN 
CE marking 
SAGITTA EVL R 
III 
38155 – Press-fit femoral stem prothesis 
2003 
CLAV. EVL 
IIb 
46646 – Orthopaedic bone screw, non-bioabsorbable, sterile 
2003 
 
 
 
Note: for the rest of the CI, under the terms "SAGITTA® EVL R" or "rods" will be included both the 
SAGITTA® EVL R  revision femoral stems and the optional CLAV distal locking keys. EVL, unless 
specifically specified. The keys can only be used with the rods, so they share the same intended use 
(target population, indications, etc.) as the latter. 

 
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D. TRACEABILITY 
The traceability of each implanted device is guaranteed by its batch number and reference number. 
E. INTENDED OBJECTIVE OF THE DEVICE IN THE INVESTIGATION 
SAGITTA® EVL R rods were used as standard, in accordance with their intended use and within their 
indications and for their usual target population, see below.  
 
F. POPULATIONS AND INDICATIONS, CONTRAINDICATIONS OF USE FOR WHICH THE 
DEVICE UNDER INVESTIGATION IS INTENDED 
i. 
INDICATED POPULATION(S) FOR THE DEVICE 
Patients intended for treatment with a SAGITTA® EVL R stem are mature skeletal adults with an 
extremely painful and/or disabled joint, resulting from the failure of a total anterior hip replacement, without 
gender restriction. 
It should be noted that SAGITTA® EVL R rods are suitable for most femoral revision with bone defects 
(Paprosky type I to III and SOFCOT stage II to IV). 
It should be noted that pregnant or breastfeeding women should not be treated with a total hip 
replacement. 
 
ii. 
DIRECTIONS 
SAGITTA® EVL R rods are intended for use in the revision of the femoral part of a total hip replacement. 
 
iii. 
CONTRAINDICATIONS 
The rods should not be implanted in patients with the following contraindications:  
Acute or chronic conditions – local or systemic (heart disease, uncompensated diabetes, regular 
hemodialysis, decreased immune system defenses, etc.). 
 
G. PREREQUISITES FOR USE 
i. 
EDUCATION AND EXPERIENCE NEEDED 
Not applicable, this is an ambispective data collection, as the subjects have already been implanted with 
the device under investigation. 
Only patient follow-up should be carried out by an orthopedic surgeon with knowledge of anatomy, 
biomechanics and reconstruction surgery of the musculoskeletal system, and previously trained in good 
clinical practices. 
Considering the large number of SAGITTA® EVL R  rod insertions performed in the prospective center 
and the experience of the surgeon who installs the SAGITTA® EVL R  rods, no learning curve - including 
retrospective - is envisaged. 
 

 
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ii. 
APPLICATION-SPECIFIC PROCEDURES 
Not applicable, this is an ambispective data collection, as the subjects have already been implanted with 
the device under investigation. 
Only prospective follow-up of patients will be carried out in accordance with the usual practice of the 
orthopaedic surgery and traumatology department in question. 
3. CI DESIGN RATIONALE  
A. EVALUATION OF THE RESULTS OF THE RELEVANT PRECLINICAL EVALUATION 
PERFORMED TO JUSTIFY THE USE OF THE DEVICE ON HUMAN SUBJECTS 
The clinical evaluation of the SAGITTA® EVL R rods and associated locking keys demonstrated their 
compliance with the essential requirements on safety, acceptability of the benefit/risk balance, clinical 
performance and acceptability of adverse events.  
However, in consideration of the elements evaluated, a post-marketing clinical study is considered 
necessary in order to:  
- 
Generate postoperative clinical data (state-of-the-art revision rate of 15.2% at 5 years / 20.8% at 10 
years). 
- 
To confirm the clinical benefits associated with the use of the rods and their performance. 
 
B. EVALUATION OF CLINICAL DATA RELATED TO THE PROPOSED HF 
The purpose of this IC is therefore to collect clinical data concerning the SAGITTA® EVL R rods as well 
as the CLV keys. EVLs, used for their intended purpose. These data will support and confirm the clinical 
evaluation of the device as agreed in the post-market surveillance plan implemented by SERF.  
This data will complement the data already available regarding the performance and safety of the implant, 
in order to support compliance with Regulation (EU) 2017/745. 
 
C. CLINICAL DEVELOPMENT STAGE 
According to Annex I of ISO 14155:2020, this clinical investigation (CI) is part of the post-market 
development stage of the device and is therefore qualified as a post-market clinical investigation, 
observational and with an additional cumbersome or invasive procedure. 
 
4. RISKS AND BENEFITS OF THE DEVICE AND THE CI 
A. EXPECTED CLINICAL BENEFITS 
The expected clinical benefits or advantages of SAGITTA® EVL R rods are pain reduction and functional 
recovery of the hip joint. 

 
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B. EXPECTED ADVERSE REACTIONS 
Known side effects (or complications) related to the use of SAGITTA® EVL R rods or the surgery required 
for their implantation are identified in the device's instructions for use and listed below: 
 
Allergy to the various materials that make up the implant and/or surgical equipment, in particular 
to metal, 
 
Pseudarthrosis, osteolysis, loosening of the prosthesis,  
 
Instability, dislocation, insufficient range of motion, 
 
Deformation, cracking or breakage of a component,  
 
Bone fracture, 
 
Collapse, migration, shortening or lengthening of the operated limb, 
 
Infection, sepsis, 
 
Delayed healing, 
 
Local, transient or permanent nerve damage,  
 
Cardiovascular disorders (hematoma, deep vein thrombosis), pulmonary embolism, 
 
Urinary tract infection, 
 
Deep abscess, fistula, 
 
Deterioration of the femoral and acetabular implant by stem/acetabulum contact during 
movements of extreme amplitude, mechanical noise may be heard when walking, 
 
The friction of components with each other can generate wear debris, corrosion or the release 
of metal particles that can induce a local reaction of the tissues, 
 
Residual hip pain. 
 
Notes: 
Some of these complications can lead to prolonged operating time, revision surgery, or implantation 
failure/postponement of surgery.  
It should be noted that any joint prosthesis is subject to wear and tear that can force the surgeon to 
operate again.  
The surgeon is responsible for complications that may result from an incorrect prescription, a defective 
operating technique or a lack of asepsis. In no case can these complications be attributed to SERF. 
 
 
In addition, situations with an increased risk of failure are also listed: 
 
Severe muscular, neurological or vascular impairments affecting the affected extremity,  
 
Destruction, loss or poor bone quality that can affect the stability of the implant (for reasons of 
fatigue resistance), severe osteoporosis, significant deformities of the joint to be replaced,  
 
Any associated conditions that could compromise the function or implantation of the prosthesis,  
 
Systemic or metabolic disorders,  
 
Intellectual inability of patients to understand the surgeon's instructions,  
 
Drug addiction, alcohol, tobacco or drug abuse,  
 
Local bone tumors that may affect the stability of the implant,  
 
Obesity, overweight, high patient activities, intensive sports practices, patients with balance 
disorders,  
 
Bone loss or poor quality likely to affect the stability of the implant (for reasons of fatigue 
resistance, it is not recommended to use the "Sagitta EVL R" rod when this bone loss is greater 
than a height of 137 mm with respect to the center head),  
 
Pregnant or breastfeeding women.  
 
C. ASSOCIATED RESIDUAL RISKS AS IDENTIFIED IN THE RISK ANALYSIS REPORT 
The risk management file for SAGITTA® EVL R rods and CLAV locking keys. EVL has been established 
in accordance with NF EN ISO 14971. 

 
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All risks associated with the design, manufacture, transport/storage, use and destruction of the device 
have been estimated. All residual risks were combined with each other after risk reduction to verify that a 
new risk was not generated. 
Taking into account all the risk control actions put in place, the overall residual risk is considered 
acceptable. 
The residual risks to the patient associated with the implantation of the rod are taken into account in the 
device's instructions for use, available in Appendix 2.  
 
D. RISKS ASSOCIATED WITH PARTICIPATION IN THE IC 
Subjects participating in the clinical investigation benefit from an operating procedure and medical follow-
up identical to the procedure and care provided in routine practice. No additional procedures are 
performed during the implantation of the prostheses or during the follow-up of the subjects. 
No specific risks associated with the participation of subjects in HF were identified. 
 
E. POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS 
No medical treatment is known to interfere with the expected results of SAGITTA® EVL R revision rod 
implantation. 
 
F. STUDIES UNDERTAKEN TO CONTROL OR MITIGATE RISKS 
Not applicable, no specific risks associated with participation in the HF have been identified. The risks to 
participants are the same as those encountered with the normal use of a SAGITTA® EVL R revision rod 
and associated postoperative follow-up. 
 
G. RATIONALE FOR THE BENEFIT/RISK BALANCE 
In accordance with the results of the clinical evaluation as well as those resulting from the risk 
management process applied to SAGITTA® EVL R revision rods, they benefit from minimized and 
acceptable risks in terms of the associated benefits when used in the context of their indication and in 
compliance with the instructions for use and recommendations issued by SERF.  
The benefit/risk ratio is therefore favourable. 
 
5. CI OBJECTIVES AND ASSUMPTIONS 
A. CLAIMS AND PLANNED PERFORMANCE THAT NEED TO BE VERIFIED 
The following claims and performances will be considered during the CI: 
- 
The implant survival rate/implant revision rate;  
- 
Reduction of pain; 
- 
Functional recovery of the hip joint 

 
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B. EXPECTED RISKS AND ADVERSE EFFECTS THAT NEED TO BE ASSESSED 
All the risks and expected adverse effects to be assessed during this CI are listed in the chapter 4. 
All the complications observed will be listed in the patient's observation form.  
Any effect, event, defect or malfunction that must be reported to the competent authorities will be reported 
in accordance with the provisions of Chapter 14. 
C. MAIN AND SECONDARY OBJECTIVES 
i. 
MAIN OBJECTIVE 
The main objective of the HF is to study the survival rate, all causes of revision combined, of SAGITTA® 
EVL R revision femoral stems inserted between 01/01/2016 and 31/12/2018, in the medium term with a 
follow-up of at least 4 years postoperatively. 
ii. 
SECONDARY OBJECTIVES 
The secondary objectives of this study are to:  
- 
Study survival rates by components and etiology (revision and revision with reconstruction) 
- 
Studying patient satisfaction with their hip prosthesis 
- 
Confirm the safety of these implants by studying any complications observed 
- 
Evaluate performance through the clinical scores of HARRIS (HHS) and forgotten prosthesis 
score (SHO-12) of femoral stems SAGITTA® EVL R. 
The criteria for each of the objectives are presented in Chapter 6.A.iii. 
D. PRIMARY AND SECONDARY ASSUMPTIONS TO BE REJECTED OR ACCEPTED BASED 
ON CI STATISTICAL DATA 
Not applicable, the objectives of this CI are descriptive.  
E. JUSTIFICATION OF PARAMETERS AND ASSUMPTIONS 
Not applicable, the objectives of this CI are descriptive.  
6. CLINICAL INVESTIGATION DESIGN 
A. GENERAL 
i. 
DESCRIPTION OF THE TYPE OF HF 
This is a post-marketing clinical follow-up study performed in routine care with an additional non-heavy 
and non-invasive Cas 4.1, single-center, non-randomized, observational, non-comparative, ambispective, 
post-marketing procedure performed under normal conditions of use. 
ii. 
 LIMITATIONS OF BIAS 
The cohort of subjects included in the study represents a comprehensive and consecutive series of 
subjects.  
The cohort will therefore make it possible to generate data in real-life conditions. 
As the inclusions are retro-prospective, this can impact the quality of retrospective data collection. 
 

 
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iii. 
PRIMARY AND SECONDARY OUTCOMES 
The outcomes presented below were chosen in accordance with the HF objectives presented in Chapter 
5C. 
 
 
Primary outcome: 
The medium-term survival rate (minimum 4 years postoperatively) is defined via the Kaplan-Meier 
analysis, for all patients who still have the stem in place at the follow-up considered. Each inflection point 
will correspond to revision surgery with removal or change of the stem, all causes of revision combined. 
 
 
Secondary outcomes: 
 
Survival rates by components and etiology 
The definition is the same as for the primary outcome but with d in subgroups: 
- 
According to the different implant assemblies 
- 
As indicated revision or revision with reconstruction. The CCAM codes related to the intervention 
will allow this distinction. 
 
Satisfaction 
The satisfaction of the subjects will be evaluated through a graduated scale with 5 levels (Likert scale) 
with the following 5 response options: 
- 
Very satisfied,  
- 
Rather satisfied, 
- 
Neither satisfied nor dissatisfied, 
- 
Rather dissatisfied, 
- 
Very dissatisfied. 
 
Complications  
All complications (events, adverse reactions and dysfunctions, serious or not, expected or not; see 
definitions in the chapter 0) observed since the implantation of the SAGITTA® EVL R rods for each subject 
will be identified, including those observed outside of the monitoring planned by this ICP.  
Complications may also be grouped according to their etiology. In all cases, the causal link with the device 
under investigation will be studied. 
 
Functional Clinical Scores and Ratings 
- 
Harris Hip Score1: 
The Harris score (HHS) is one of the main functional clinical scores used after hip replacement surgery 
and evaluates 3 "items" relating to the diseased or operated hip:  
- 
Pain (44 points) 
- 
Function (47 points)  
- 
Mobility (9 points) 
 
For a maximum total score of 100 (minimum score:0), the HHS results will be categorized as follows:  
 
 
 
 
1 Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. 
An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969; 51: 737–55. 

 
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HHS 
Excellent 
90-100 
Good 
80-89 
Correct 
70-79 
Bad 
< 70 
 
The HHS fill grid is available in Appendix 5. 
 
- Forgotten Hip Score (FJS-12):2 
The Forgotten Hip Score (SHO-12) is the French version of the FJS-12 (Forgotten Joint Score). The 
objective of this self-questionnaire is to estimate the degree of neglect of the hip and knee prosthesis 
through 12 questions. 
Each item has 5 levels of response:  
Never: 0 points 
Almost never: 1 point 
Rarely: 2 points 
Sometimes: 3 points 
Often: 4 points 
The sum of the items is divided by the number of items and multiplied by 25 to obtain a score out of 100. 
The OHSS Fill Grid is available in Appendix 6. 
 
Radiographic evaluation: 
 
- 
Paprosky's classification3 :  
This classification makes it possible to define the preoperative bone defect. 
 
 
 
 
 
 
 
 
2 Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: 
validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar; 27(3):430-436.e1. DOI: 
10.1016/J.ARTH.2011.06.035. Epub 2011 Oct 13. PMID: 22000572. 
3 Della Valle C.J., Paprosky W.G. Classification and an algorithmic approach to the reconstruction of femoral 
deficiency in revision total hip arthroplasty J Bone Joint Surg Am 2003 ;  85 (Suppl. 4): 1-6 

 
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- 
Preoperative fractures will be evaluated by the Vancouver Stadium4:  
This classification of periprosthetic hip fractures proposed by Duncan and Masri is the most widely used 
classification system. It takes into account the site of the fracture, the condition of the femoral implant and 
the quality of the surrounding femoral bone material. 
 
 
 
- 
Osseointegration of the stem will be assessed by the Engh score 5 (see Appendix 7) 
Measured on postoperative X-rays, it is divided into 2 subparts: fixation and stability. 
The final score can be classified into 4 categories:  
- 
<-10°: unstable 
- 
-10 to <0°: suboptimal but unstable 
- 
0 to +10°: suspected bone growth 
- 
> +10°: osseointegration 
 
- 
Bone reconstruction will be measured by the cortico-medullary index 6 
This index represents the fineness of the cortex and allows us to evaluate bone quality. 
 
𝐸𝑝𝑎𝑖𝑠𝑠𝑒𝑢𝑟 𝑜𝑠 𝑐𝑜𝑟𝑡𝑖𝑐𝑎𝑙
𝐷𝑖𝑎𝑚è𝑡𝑟𝑒 𝑒𝑥𝑡é𝑟𝑖𝑒𝑢𝑟 𝑑𝑢 𝑓é𝑚𝑢𝑟ൈ100 
 
- 
Femoral offset  
The femoral offset is the distance between the diaphyseal axis and the center of the femoral head. 
 
 
 
 
 
44 Glick, Y. Vancouver classification of periprosthetic hip fractures. Article reference, Radiopaedia.org. (accessed on 
18 Oct 2022) https://doi.org/10.53347/rID-52713 
5 Engh C.A., Massin P., Suthers K.E. Roentgenographic assessment of the biologic fixation of porous-surfaced 
femoral components Clini Orthop Relat Res 1990;  257 : 107-127 
6 Barnett E., Nordin B.E. The radiological diagnosis of osteoporosis: a new approach Clin Radiol 1960 ;  11 : 166-
174 

 
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iv. 
METHODS AND TIMING OF EVALUATION, RECORDING AND ANALYSIS OF VARIABLES 
The table below presents the different stages and moments of patient follow-up, and the acquisition of 
related data. 
 
Study Outline 
Retrospective 
Prospective part 
Pre-
operative 
data 
Implantation 
Immediate 
post-
operative 
follow-up 
Inclusion in 
the study 
Medium-term 
monitoring 
 
Topic Information 
 
 
 
X 
 
Verification of 
inclusion criteria 
 
 
 
X 
 
Demographics: 
Age, height, weight, sex  
X 
 
 
 
 
Medical and surgical 
history 
X 
 
 
 
 
Implantation of the 
prosthesis 
Operative report:  
Date of operation, type of 
anesthesia, approach, 
type of implant and 
assembly performed, 
coding of the surgical act 
(CCAM code) 
 
X 
 
 
 
Radiological 
examination 
X 
 
 
 
X 
Functional score 
assessment 
Modified HHS – SHO-12 
X 
(except SHO-
12) 
 
 
 
X 
Satisfaction 
 
 
 
 
X 
Adverse event 
collection  
 
X 
X 
X 
X 
 
Complications and serious adverse events will be collected independently of the retrospective and 
prospective parts but over the entire period since the intervention. 
 
v. 
EQUIPMENT TO BE USED TO EVALUATE CI VARIABLES AND PROVISIONS FOR MAINTENANCE AND 
CALIBRATION MONITORING 
No specific equipment is required for the evaluation of HF variables. No additional examination is required. 
The radiological examination is performed prior to the follow-up visit, in local radiology centers as well as 
for follow-up according to standard operating procedures.  
In standard tracking, X-rays are taken before each follow-up. 
 
vi. 
PROCEDURES FOR REPLACING SUBJECTS, IF APPLICABLE 
N/A: This is a retrospective data collection. Subjects leaving the study will not be replaced. 

 
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vii. 
INVESTIGATION SITE(S) 
An investigation site has been identified for the conduct of this CI:  
Rouen University Hospital  
Charles Nicolle Hospital  
37 Bd Gambetta 
76000 Rouen 
viii. 
END OF CI 
HF will be considered complete when the last subject has completed their single follow-up visit. 
In case of premature termination of the study, refer to Chapter 16 of this protocol. 
B. DEVICE(S) UNDER INVESTIGATION AND COMPARATOR(S) 
No comparator is used for this CI. 
i. 
DESCRIPTION OF EXPOSURE TO THE DEVICE(S) UNDER INVESTIGATION OR COMPARATOR(S) 
For implantation of a SAGITTA® EVL-R femoral stem in the context of hip arthroplasty, the subject may 
be exposed a maximum of 2 times (2 hips). 
The patient is exposed, throughout the time that the implant remains in place, to the following materials:  
Titanium TA6V (ISO 5832-3) for the stem and keys. 
Hydroxyapatite (ISO 13779-2 and ISO 13779-6) for stem coating. 
The human tissues in contact with these materials are: femur, soft tissues, cartilage, blood vessels, and 
blood. 
ii. 
LIST OF ANY OTHER MEDICAL DEVICES OR DRUGS TO BE USED DURING HF THAT ARE NOT ALREADY LISTED 
IN THE INSTRUCTIONS FOR USE 
No additional drug or surgical treatment is required as part of this HF.  
iii. 
NUMBER OF DEVICES UNDER INVESTIGATION TO BE USED 
One (1) device is implanted per femur. 
In the particular case of subjects operated bilaterally, two (2) devices may be implanted in the same 
subject, at a rate of one (1) per femur. 
C. TOPICS 
i. 
INCLUSION CRITERIA  
- 
Patient of legal age on the date of surgery, 
- 
Patient implanted with a SAGITTA® EVL-R revision femoral stem in the context of its indications 
between 01/01/2016 and 31/12/2018, 
- 
Patient benefiting from a health insurance scheme. 
 
ii. 
CRITERIA FOR NON-INCLUSION  
- 
Patient who have not expressed consent to the collection of their data and participation in the 
study, 
- 
Patient unable to understand the surgeon's instructions or perform postoperative follow-up. 
- 
Patient with a contraindication to the use of the SAGITTA® EVL R revision femoral stem 
- 
Patient implanted with a SAGITTA® EVL R revision femoral stem outside of their indication 

 
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iii. 
CRITERIA FOR SUBJECT'S EXCLUSION 
No exclusion criteria were used in this study. 
iv. 
CRITERIA AND PROCEDURES FOR WITHDRAWING A SUBJECT, DISCONTINUING PARTICIPATION OR LOSING 
SIGHT OF A SUBJECT 
When a subject wishes to discontinue participation (for any reason), the principal investigator will be 
required to document the subject's exclusion or withdrawal of consent. Whenever possible, the reason for 
the withdrawal of consent should be recorded, especially in the case of a serious adverse event.  
When a subject is excluded or if he withdraws his consent, he continues to be followed normally by his 
orthopaedic surgeon, as part of his normal post-operative follow-up.  
All subjects for whom the principal investigator is unable to get in touch after 3 telephone reminders will 
be considered as 'Lost to follow-up'. 
Because HF is ambispective, it is not possible to replace subjects who are lost to follow-up or excluded. 
 
v. 
TIME OF ENLISTMENT 
Participation in this HF will be offered to patients who meet the inclusion criteria during their postoperative 
follow-up visit. 
vi. 
TIMING OF RANDOMIZATION 
The CI design is not applicable and does not include the use of a comparator or comparison arm, so there 
can be no randomized assignment to any of these arms. 
vii. 
EXPECTED DURATION OF PARTICIPATION OF EACH TOPIC 
Considering the inclusion period (01/01/2016 – 31/12/2018), the ambispective nature of HF and the 
planned postoperative follow-up, the duration of participation for a subject will be a maximum of 1 medium-
term follow-up (minimum 4 years postoperatively) for patients implanted between 2016 and 2018.  
viii. 
NUMBER OF REQUIRED TOPICS TO BE INCLUDED IN THE CI 
Over the period of implantation under consideration (01/01/2016 – 31/12/2018), 120 patients were 
implanted with a SAGITTA® EVL-R rod in the investigation center selected for HF and can potentially be 
included. Only patients who meet the screening criteria and agree to participate (inclusion) will be included 
and their data collected. 
 
ix. 
INCLUSION PERIOD 
The implementation period considered for the HF is retrospective and extends from 01/01/2016 to 
31/12/2018 for the centre in question. 
Inclusion of subjects will occur as patients travel to their follow-up visit. Inclusions will be carried out in 5 
months, corresponding to the time needed to reconvene all patients. 
x. 
TOTAL EXPECTED DURATION OF CI 
The study will begin once all the necessary opinions and authorizations have been obtained. 
The total duration of the study depends only on its prospective part, which consists of monitoring the 
subjects in the medium term, at least 4 years  postoperatively. Retrospective collection will be carried out 
as follow-up visits are made, as soon as the patient's consent is obtained. The total duration of the study 
will be 5 months for follow-ups, at the date of writing of this protocol. 
xi. 
RELATIONSHIP BETWEEN THE STUDY POPULATION AND THE TARGET POPULATION 
Due to the ambispective nature of HF, for which implantation of SAGITTA® EVL R rods has already been 
performed, implanted patients fit the target population. The selection criteria ensure that only subjects 
that exactly match the target population will be included in the CI. 

 
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xii. 
VULNERABLE POPULATIONS, PREGNANT AND/OR BREASTFEEDING WOMEN 
The target population of SAGITTA® EVL R rods as defined in Chapter 2.F.i does not include any 
vulnerable populations. In addition, the selection criteria as mentioned in chapters 6.C.i to 6.C.iii make it 
possible to ensure the non-inclusion of vulnerable patients and respect for the target population. 
 
D. PROCEDURES 
i. 
DESCRIPTION OF ANY HF-RELATED PROCEDURES TO WHICH SUBJECTS ARE SUBJECTED (INCLUDING 
DEVIATIONS FROM STANDARD CARE)  
Only an additional procedure that is neither heavy nor invasive is required when participating in this HF 
compared to the standard care provided as part of the systematic follow-up during hip replacement 
revision surgery in the investigation center in question. Namely, a quality of life questionnaire (SHO-12 
forgotten hip score) and a functional score (HHS Harris Hip Score) are requested in addition. These can 
be completed in part by the patient or collected by the investigator. 
As far as the retrospective part is concerned, all the necessary data will be collected directly from the 
patients' medical records, the subjects having already undergone the following visits: preoperative visit, 
intervention, immediate postoperative follow-up. Depending on the date of the operation, one or more 
intermediate postoperative follow-ups may have been performed. Data on these interim follow-ups will 
not be collected. Only relevant data in terms of serious adverse events will be collected for these interim 
follow-ups. 
For the prospective part, which concerns only the medium-term postoperative follow-up (minimum 4 years  
) taking place after the inclusion of patients in the study, the procedures to which the subjects participating 
in HF will be subjected are listed and briefly described below. These procedures are the same as those 
performed as part of the systematic follow-up of a hip replacement in the investigation center in question. 
At the end of the investigation, the subjects continue to be monitored according to the habits of the center. 
 
Inclusion of subjects in the CI 
Patients scheduled for their usual follow-up visit will be selected (detailed process available in Chapter 
13) and at the end of the screening process, the patient will be included if he or she consents to participate 
in the study. 
 
Follow-up visits 
The follow-up visit will take place as follows: the subject meets the investigator for the systematic clinical 
examination as carried out in the investigation center, with a search for signs indicating the possible 
presence of a complication in the operated hip and the evaluation of the patient's satisfaction. The pain 
experienced by the subject will be reported via the HHS score. HHS and SHO-12 functional scores are 
collected by the investigator via the appropriate questionnaires submitted to the patient (see Appendices 
5 and 6 and section 6.A.iii). Bone reconstruction and osseointegration are evaluated on the X-ray 
performed prior to the follow-up visit to document a complication. If a revision, removal or change of 
implant is necessary or in the case of the detection of a complication, the investigator records this in the 
patient's file. 
 
Summary of the Study 
1. 
Identification of eligible participants: 
During a medium-term postoperative follow-up consultation (minimum 4 years ) in orthopedic surgery 
(performed as a clinical routine) for patients implanted with a SAGITTA® EVL R revision rod during the 
period under consideration, they will be offered to participate in the study 

 
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2. 
Information and collection of consent from people agreeing to participate in the medical 
consultation 
3. 
Acquisition of clinical data during the follow-up visit 
4. 
End of participation for the participant. 
 
ii. 
DESCRIPTION OF ACTIVITIES CARRIED OUT BY THE PROPONENT'S REPRESENTATIVES (EXCLUDING 
MONITORING) 
The sponsor's representatives carry out the following tasks prior to the start of the CI (obtaining all 
necessary authorisations):  
- 
Selection, definition of roles and responsibilities and verification of the necessary experience of the 
various stakeholders and collection of possible conflicts of interest; 
- 
Documentary preparation of the study and obtaining the necessary authorizations through the 
required regulatory submissions; 
- 
Registration of the CI on a public database.  
During the conduct of the study, the proponent's activities are: 
- 
Documentation of exchanges between stakeholders as well as competent authorities in charge of 
CI; 
- 
Evaluation of adverse events reported by the investigator and transmission of the required 
information to the competent authorities in charge of the HF, as well as to other stakeholders; 
- 
Drafting, documentation of any amendments, as well as obtaining the necessary authorizations if 
applicable; 
- 
Update if necessary the risk analysis of HF according to the complications observed; 
- 
Communication with investigators of HF advancement; 
- 
Collection of questions from investigators, transmission and documentation of answers to 
investigators. 
When the HF is completed (last visit to last follow-up of the last patient), the sponsor is responsible for 
the following activities: 
- 
Closure of the CI according to the procedures provided; 
- 
Carrying out the analysis of the data generated; 
- 
Issue of the investigation report. 
The monitoring activities for which SERF is responsible are discussed in §6.E. 
iii. 
ANY KNOWN OR FORESEEABLE FACTORS THAT MAY AFFECT THE EFFECTS OR INTERPRETATION OF THE 
RESULTS 
The observational nature of HF and its duration can have several consequences on its outcomes. First, 
a high number of patients who have been lost to follow-up or died are expected.  
However, replacement of patients who have been lost to follow-up or who have died is not considered 
due to the ambispective nature of the study.  
The bias inherent in the retrospective part could also limit the quality of the data collected. 
As the study is observational, factors such as age, associated comorbidities or any other confounding 
factors, will be taken into account during the analysis of the data.  
E. MONITORING PLAN 
The monitoring and audit procedures described in the Good Clinical Practices will be respected. 
The monitoring plan is consistent with SERF's usual practices for CI monitoring.  
It includes at least one opening visit to the IC, one (or more if necessary) monitoring visits and a closing 
visit. All monitoring activities will be carried out and/or taken care of by SERF. 

 
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7. STATISTICAL CONSIDERATIONS 
A. DATA ANALYSIS 
The data will be analyzed for the population as treated, since the implantation is performed prior to the 
start of the HF (retrospective part), in accordance with the purely descriptive nature of the objectives.  
The final analysis will take place when the prospective part of the HF is completed, i.e., when the last 
patient has been seen again during the follow-up visit and the various requests made during the 
monitoring activities have been closed. 
B. DATA DESCRIPTION 
Demographic data of the included population and surgery, as well as endpoints and safety data, will be 
presented descriptively: 
- 
Discrete qualitative and quantitative data will be summarized by their number, percentages, and 
percent confidence interval for each modality; 
- 
Continuous quantitative data will be summarized by their mean, standard deviation, mean 
confidence interval, median, minimum and maximum. 
 Clinical data will be analyzed before and after surgery at each follow-up visit (functional measures) when 
available, including in terms of HHS and SHO-12 functional score if available, calculating score changes 
between preoperative and follow-up states. The confidence interval of the observed differences will make 
it possible to quantify the improvement or deterioration of the clinical status. 
Radiological data will be analyzed before and after surgery at the follow-up visit. X-rays will document 
possible cases of complications (causal link with the bone defect), and provide information in terms of 
osseointegration/bone reconstruction.  
Failure and revision rates will be analyzed by a Kaplan-Meier survival curve, with any revision surgery 
with removal or change of the SAGITTA EVL-R rod and/or locking keys as the inflection point. If several 
causes are identified, specific survival rates can be calculated. 
The safety data related to the medical device will be presented throughout the duration of the follow-up. 
The complications observed can be grouped according to the data describing them provided and their 
etiology. 
 
C. ANALYTICAL PROCEDURES 
i. 
CALCULATION OF CONFIDENCE INTERVALS 
All confidence intervals will be calculated at 95%, i.e.: 𝑧ഀ
మൌ1.96 
The confidence intervals for discrete qualitative and quantitative variables will be calculated using the 
following formula:  
𝐼𝐶ଽହൌ ቎𝑝െ𝑧ఈ
ଶൈඨ𝑝ൈሺ1 െ𝑝ሻ
𝑛
 ; 𝑝൅𝑧ఈ
ଶൈඨ𝑝ൈሺ1 െ𝑝ሻ
𝑛
቏ 
With:  
- 
𝐼𝐶ଽହ, the 95% confidence interval  
- 
p, the proportion observed; 
- 
𝑧ഀ
మൌ1.96, the value derived from the normal distribution for a risk α 5%; 
- 
n, the sample size.  
 

 
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The confidence intervals for the means of the continuous quantitative variables will be calculated using 
the following formula:  
𝐼𝐶ଽହൌ ൤𝑚െ𝑧ఈ
ଶൈ𝜎
√𝑛 ; 𝑚൅𝑧ఈ
ଶൈ𝜎
√𝑛൨ 
With:  
- 
𝐼𝐶ଽହ, the 95% confidence interval  
- 
m, the observed mean; 
- 
σ, the standard deviation observed 
- 
𝑧ഀ
మൌ1.96, the value derived from the normal distribution for a risk α 5%; 
- 
n, the sample size.  
 
ii. 
II. CALCULATION OF THE REVISION RATE 
Thus, the all-cause revision rate will be calculated as follows: 
𝑇𝑎𝑢𝑥ൌ 𝑛
𝑁 
Where n is the number of patients who underwent revision surgery and N is the total number of patients 
included in HF.  
Specific revision rates will be calculated using the following formula: 
𝑇ோൌ 𝑛௜
𝑁 
With:  
- 
nor, the number of patients who required revision surgery for reason i;  
- 
N, the sample size;  
 
The confidence interval of each revision rate thus observed (one for each reason for revision) will also be 
calculated as mentioned above. 
iii. 
CALCULATION OF THE SURVIVAL RATE 
The Kaplan-Meier analysis is based on the calculation of cumulative conditional probabilities. The survival 
rate will be calculated using the following formula: 
𝑆௧ሺ௜ሻൌ 
ෑ
𝑆௧ሺ௜ሻ
௧ሺ௜ିଵሻ
௧ሺ௜ିଵሻழ௧ሺ௜ሻ
ൌ 
ෑ
1 െ𝐷௜
𝑁௜
௧ሺ௜ିଵሻழ௧ሺ௜ሻ
 
 
With: 
- 
𝑆௧ሺ௜ሻ, the probability of having the implant in place so far;𝑡ሺ௜ሻ 
- 
𝑆೟ሺ೔ሻ
೟ሺ೔షభሻ
, the probability of still having the implant in place knowing that the implant was in place at 
;𝑡ሺ௜ାଵሻ 𝑡ሺ௜ሻ 
- 
𝐷௜ൌ1 െ 𝑁௦ሺ௜ሻ, the number of subjects who required removal or change of implant, observed at 
the time;𝑡ሺ௜ሻ  
- 
𝑁ௌሺ௜ሻ, the number of subjects with their implant still in place at the time observed at the time;𝑡ሺ௜ሻ  
- 
𝑁௜ൌ 𝑁ௌሺ௜ିଵሻെ 𝐷௜െ 𝐶௜, the number of subjects at risk of implant removal or change, observed at 
time;𝑡ሺ௜ሻ  
- 
𝐶௜, the number of censored subjects (lost to follow-up, deceased, having left the study) observed 
between time and ;𝑡ሺ௜ିଵሻ𝑡ሺ௜ሻ 
D. DEGREES OF SIGNIFICANCE AND STRENGTH OF THE CI 
The objectives of this CI are descriptive regarding the use of SAGITTA® EVL-R rods; Thus, no statistical 
test is performed to compare the results with a comparator device. 

 
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E. SAMPLE SIZE 
According to the available data, 120 SAGITTA® EVL R revision rods were implanted at the Rouen 
University Hospital – Charles Nicolle Hospital between 01/01/2016 and 31/12/2018. The final sample size 
will reflect the current practice of the selected investigation center based on the patient base as observed 
over the inclusion period and meeting the selection criteria.  
The total sample size will depend on the number of subjects who do not object to participation and data 
collection, the number of subjects who have died and have been lost to follow-up.  
F. LEARNING CURVE AND DATA CONSIDERATION 
No learning curve will be considered due to the retrospective nature (previously implanted subjects), the 
experience of the surgeon who implanted the patients, and the number of annual rod insertions in the 
selected investigation centers. All patients who meet the inclusion criteria and do not object to participation 
and data collection will be included.  
G. HF PASS/FAIL CRITERIA 
The nature of HF is observational and its objectives are only descriptive, no statistical criterion defines 
the success or failure of the investigation. 
H. INTERIM ANALYSES AND DISCONTINUATION OF CI FROM A STATISTICAL POINT OF 
VIEW 
i. 
INTERIM ANALYSES 
No interim analysis is envisaged because the prospective part of the study is limited to the patient's only 
and last follow-up visit. 
ii. 
CESSATION OF HF BASED ON STATISTICAL CRITERIA 
The nature of HF is observational, ambispective, and since its objectives are only descriptive, there is no 
statistical criterion that defines its early termination. 
I. ACCOUNTING FOR BIASES  
i. 
STATISTICAL BIAS 
The statistical biases usually limited by the use of a comparator arm with a randomized distribution for 
each arm and double-blind conduct cannot be implemented for this HF due to its ambispective non-
interventional non-comparative and therefore non-randomized, open-label nature.  
However, the subjects included in this study will constitute an ongoing and exhaustive series.  
ii. 
CONFOUNDING FACTORS 
Medical and surgical history, as well as intercurrent pathologies, or any other factor such as age, weight, 
etc. and that may impact clinical outcomes will also be considered during multivariate analysis. 
iii. 
SPECIFYING SUBGROUPS FOR ANALYSIS 
Subjects can optionally be classified by assembly for analysis.  
In addition, an analysis according to etiology (revision, revision with reconstruction) is envisaged. For this 
purpose, the CCAM codes related to the surgical procedure will be recovered. 

 
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iv. 
CHECKING AND ADJUSTING ERROR PROBABILITIES 
The purpose of this clinical investigation is to describe current practice, with descriptive objectives for the 
use of SAGITTA EVL-R rods; Thus, no statistical tests or adjustments to these tests are performed. 
J. HANDLING MISSING, UNUSED OR ERRONEOUS DATA, INCLUDING ABANDONMENTS 
AND WITHDRAWALS 
i. 
DATA INCLUSION METHODOLOGY 
 
The simple imputation replacement method can be used if necessary: replace the missing data with a 
plausible value (mean/median of the variable for the follow-up under consideration, for example) if less 
than 10% of the data are missing.. 
ii. 
EXPLORATORY AND SENSITIVITY ANALYSES 
The purpose of this clinical investigation is to describe current practice, the objectives being descriptive 
concerning the use of SAGITTA® EVL-R rods; Thus, an exploratory analysis and/or sensitivity analysis 
may be carried out but will not be mandatory. 
K. PROCEDURES FOR REPORTING ANY DEVIATIONS FROM THE ORIGINAL STATISTICAL 
PLAN 
All deviations observed and/or achieved from the statistical plan mentioned above will be presented, 
justified and their impact analyzed, in the study report.  
L. IN THE CASE OF MULTICENTRE INVESTIGATIONS, MINIMUM AND MAXIMUM NUMBER 
OF SUBJECTS TO BE INCLUDED FOR EACH CENTRE 
Not applicable, CI is monocentric. 
8. DATA MANAGEMENT 
A. DATA ENTRY AND COLLECTION METHODS 
The data will be collected from the patient records in the paper CRF directly by the investigator. The CRF 
data will then be entered into a database by a representative of the sponsor.  
In accordance with applicable laws and regulations, data confidentiality will be ensured by appropriate 
security means:  
• Patients will be identified in the CRF and the clinical database by a numerical identifier combining the 
number of the center and the number of the patient. Only the centres will keep a confidential list of included 
patients that will link the patient's ID to their identity.  
• No personal data will be collected. 
 

 
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B. PROCEDURES FOR EXAMINING DATA, CLEANING UP DATABASES, AND ISSUING AND 
RESOLVING DATA QUERIES 
The data will be collected from the CRFs into the study database directly in the investigator center during 
a monitoring visit.  At a minimum, the date of collection of the CRF or the request and the identification 
number of the subject will be reported. A form collecting the CRFs entered will be signed by the monitor 
and countersigned by the investigator to attest to the integrity of the data entered. 
Data entry may result in requests for clarification called "queries", to which the investigator will respond 
by confirming or modifying the data concerned. These requests for clarification are annexed to the CRF 
at the investigator and the sponsor. 
C. PROCEDURES FOR VERIFYING, VALIDATING AND SECURING ELECTRONIC CLINICAL 
DATA SYSTEMS 
i. 
GENERAL 
In order to ensure the verification, validation and security of the electronic systems generating, or 
managing the clinical data entered into the above-mentioned database, SERF has put in place the 
following elements: 
- 
Update monitoring system; 
- 
Host proxy system; 
- 
Individual workstations equipped with anti-virus software with automatic updates; 
- 
Locking, password access and encryption of mobile workstation partitions; 
- 
Triple level of backups: real-time synchronization of virtual machines, backup to a production 
server and daily encryption and transfer to a backup hosting site; 
- 
Secure erasure of SERF disks prior to disposal by physical destruction; 
- 
Network protected by a security box (VPN).  
ii. 
SPECIFIC 
Backups are encrypted by private keys, and access to the study's production server is protected by NTFS 
rights. 
Clinical data is hosted on the same server as the rest of the SERF information system, but accessible 
only by the sponsor's clinical department staff and hierarchy. 
Access to the clinical data entry system is through username/password authentication. Passwords are 
controlled for complexity and should be changed regularly. 5 unsuccessful attempts block access to the 
account. 
Any connection to the system and any changes in clinical data are recorded for the duration of the study. 
D. MAINTAINING CONFIDENTIALITY AND RESPECTING THE PRIVACY OF SUBJECTS 
The confidentiality of the subjects will be ensured by pseudonymization using a patient number (with 3 
incremented digits) assigned to the person who is willing to participate in the research and communicated 
on all the documents necessary for the research; or by erasing by appropriate means nominative data on 
copies of source documents, intended for research documentation. 
E. DATA RETENTION 
The investigator should maintain all study documents in accordance with Good Clinical Practice and 
regulations. The records will be kept until SERF authorizes their destruction. If the investigator declines 
this responsibility, the retention of records will be assigned to an individual who accepts this responsibility. 
In the event of a transfer of responsibility or place of storage, the sponsor must be informed in writing. 

 
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Data archiving after the completion of the study will be performed in accordance with SERF procedures 
for archiving clinical data from an investigation. The database that gave rise to the statistical analysis will 
also be locked and archived by the person responsible for the analysis (paper or computer). 
F. RETENTION PERIOD 
In accordance with Annex XV Chapter 3.3 of Regulation (EU) 2017/745 on medical devices, which sets 
out the retention period by the sponsor and the investigator of the documents and data, the data retention 
period shall be 15 years after the end of the investigation. 
G. OTHER ASPECTS OF CLINICAL QUALITY ASSURANCE 
In accordance with the General Data Protection Regulation, an impact assessment of the study will be 
carried out by SERF; The study will also be registered in a specific register.  
In addition, as part of the implementation of its quality management system, an internal SERF auditor 
may be required to carry out an audit of the investigating centre. This audit will ensure compliance with 
the procedures envisaged by this protocol during the conduct of the investigation.  
The health authorities may also be required to carry out audit activities of the investigating centre.  
9. AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
All amendments to the protocol will be made known to all investigators involved in the research. 
Amendments will be notified to the competent authorities and the Ethics Committee in accordance with 
the regulations in force.  
Investigators sign each amendment prior to implementation and after approval by any authority that 
previously approved the protocol. Finally, the investigators undertake to respect the content. 
Any amendment that modifies the coverage of the subjects or the benefits, risks and constraints of 
research will be the subject of a new information letter and the signing of a non-opposition form, the 
collection of which follows the same procedure as that mentioned in the chapter 13. 
10. 
DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
A. STATEMENT THAT THE INVESTIGATOR IS NOT AUTHORIZED TO DEVIATE FROM THE 
ICP 
The investigator is not allowed to deviate from the Clinical Investigation Plan, except in the context of 
protecting the subject's rights, safety, and well-being under emergency conditions. In this case, any 
deviations must be documented and forwarded to the sponsor as soon as possible. 
B. PROCEDURE FOR RECORDING, REPORTING AND GAP ANALYSIS IN RELATION TO THE 
CIP 
This study will be carried out in accordance with the requirements of the protocol. Any deviation from 
these criteria will be justified and carefully documented. The deviation will be considered a major deviation 
and considered for the final analysis of the study if it relates to any of the following: 
- 
Information and consent procedure; 
- 
Inclusion/non-inclusion criteria. 
- 
Follow-up visit not carried out; 

 
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- 
Primary outcome. 
Major deviations from the protocol will be recorded and will be mentioned in the final report.  
In the event of a discrepancy in the subject's information or consent, the investigator must immediately 
correct the deviation by following the steps outlined in Chapter 13. 
In all cases, the investigator should justify the deviation during a monitoring visit, by means of the 
appropriate documentation.  
C. NOTIFICATION REQUIREMENTS AND DEADLINES 
Notification of a deviation from the protocol must be communicated to the sponsor as soon as possible 
via letter, email or any other means of communication containing the justification and documentation 
relating to the deviation. 
D. CORRECTIVE AND PREVENTIVE ACTIONS AND CRITERIA FOR DISQUALIFICATION OF 
THE PRINCIPAL INVESTIGATOR 
At the first major deviation, intentional or unintentional - except for cases of protection of patients' rights, 
safety and well-being - observed by the sponsor, a reminder of the procedures to be followed will be made 
to the investigator and/or members of the investigating team. 
11. 
DEVICE ACCOUNTING 
Article R1121-3-1 of the Public Health Code only provides for the free supply of devices in cases of 
interventional research.  As the study is carried out after obtaining the CE marking and the device is used 
for its intended use, the requirements of this chapter do not apply.  
A. ACCOUNTING PROCEDURE 
Not applicable. 
 
B. PROCEDURES AND INSTRUCTIONS FOR THE RETURN OF POTENTIALLY HAZARDOUS 
DEVICES 
Not applicable. 
12. 
DECLARATION OF CONFORMITY  
A. DECLARATION OF HELSINKI 
The study will be conducted in accordance with the ethical principles that are set out in the Declaration of 
Helsinki. 

 
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B. COMPLIANCE WITH ISO 14155 NF AND NATIONAL AND/OR REGIONAL 
REGULATIONS 
The study will be conducted in accordance with the International Conference on Harmonization for Good 
Clinical Practice (ICH/GCP) transposed into the ISO 14155:2020 Standard. 
It will be carried out in accordance with applicable European, national and local regulatory requirements.  
The information of subjects and the processing of data will be carried out in accordance with Regulation 
2017/745 on medical devices, the Data Protection Act of 6 January 1978 in its latest version in force and 
the General Data Protection Regulation (EU) 2016/679 of 27 April 2016. 
 
In accordance with the regulations, a data controller is the referent: 
Nathalie Trétout, the data controller 
Email: rgpd@serf.fr or n.tretout@menix.fr 
 
C. APPROVALS/FAVOURABLE OPINIONS REQUIRED 
The investigation is considered a 4.1 case study according to the French national classifications from the 
ANSM. Consequently, an application must be submitted to a CPP and the ANSM. 
Validation by a CPP and compliance with the MR001 reference methodology are required prior to the 
start of the study. 
D. ADDITIONAL REQUIREMENTS 
Any additional requirements on the part of the Committee for the Protection of Persons or the ANSM will 
be respected and implemented before the start of the investigation. 
E. INSURANCE  
This study is a non-interventional post-marketing study. As such, the sponsor of the study, SERF, in 
accordance with the legislation in force, is not obliged to take out specific insurance for research. 
F. INVESTIGATIVE FUNDING 
The financing plan for the study is drawn up separately from the protocol. 
13. 
PROCESS FOR OBTAINING NON-OPPOSITION 
A. GENERAL PROCESS FOR OBTAINING INFORMED CONSENT 
Informed consent is mandatory for studies meeting the Reference Methodology MR-001. 
Prior to the first inclusion and in compliance with good clinical practices, the study investigator(s) are 
trained by the sponsor in the patient information process as well as in the collection of informed consent 
during the study set-up visit.  
During a patient's visit planned as part of the systematic follow-up of hip replacements, the investigator 
offers to participate in HF if he or she meets the selection criteria.  

 
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To do this, the investigator provides the information relating to the oral test and gives the information letter 
(see Appendix 3). The investigator also answers any questions he may have. After the subject has been 
able to consider all the information and has been given the newsletter, and after the reflection period that 
has been given to him, he then has the choice to give his consent to his participation in the study and the 
collection of his data. The patient will be able to give consent from the moment he has received all the 
information until his next follow-up visit.  
If the investigator expresses his or her consent, he or she obtains the consent in the form provided (see 
Appendix 3), of which he or she keeps the copy that he or she has imperatively dated and signed, in the 
investigator's binder, and also gives a copy to the subject. The patient is then included in the HF and 
considered as a "subject" participating in the HF. The patient has time to think about it after the 
presentation of the study to give his or her agreement or not to his participation.  
 
A copy of the newsletter is given to the subject. 
B. SPECIAL CASES 
No special case is envisaged because the study is carried out in routine care. 
14. 
ADVERSE EVENTS, ADVERSE DEVICE REACTIONS, AND 
DEVICE DEFECTS 
The term 'complications' used by the investigators includes the different definitions of event, adverse 
reaction, expected or not, serious or not, and dysfunction.  
A. DEFINITIONS OF ADVERSE EVENTS AND ADVERSE REACTIONS TO THE DEVICE 
Adverse event (AE): any adverse event, unintentional illness or injury, or adverse clinical signs, including 
an abnormal laboratory finding, in participants, users, and others, in the course of a clinical investigation, 
whether or not related to the device under clinical investigation  
Serious Adverse Event (SAE): any adverse event that resulted in: 
- 
Death. 
- 
A serious deterioration in the participant's state of health, which is the cause:  
o 
a life-threatening illness or injury, or  
o 
a permanent impairment in anatomical structure or function, or  
o 
hospitalization or prolongation of the patient's hospitalization, or  
o 
a medical or surgical procedure to prevent any life-threatening illness or injury or 
permanent impairment of anatomical structure or function, or  
o 
of a chronic disease. 
- 
Fetal distress, death of the fetus, congenital physical or mental impairment, or birth defect. 
A planned hospitalization due to a pre-existing condition or a procedure required by the clinical 
investigation plan, without a serious deterioration in health, is not considered a serious adverse event. As 
a reminder, the definitions applicable in the context of medical device vigilance (corresponding to post-
marketing surveillance of medical devices). 
Serious incident: any incident that has directly or indirectly caused, likely to have resulted or likely to 
result in:  
- 
The death of a patient, user, or any other person,  
- 
A serious deterioration, temporary or permanent, in the state of health of a patient, a user or any 
other person, 

 
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A serious threat to public health. 
Serious Adverse Device Reaction (SAE): An  adverse reaction to the device that results in one of the 
characteristic consequences of a serious adverse event.  
Unexpected serious adverse reaction of the device (EIGID): a  serious adverse reaction of the device 
whose nature, impact, severity and consequences have not been identified in the current risk assessment. 
 
B. DEFINITION OF DEFECTS AND MALFUNCTIONS OF THE DEVICE 
Malfunction: Failure of the medical device under investigation to function in accordance with its intended 
use when used in accordance with the instructions, clinical investigation plan, or investigator's brochure. 
 
Device Defect: Any defect in the identity, quality, durability, reliability, safety, or performance of a device 
under investigation, including any malfunction, misuse, or defect in the information provided by the 
manufacturer. 
 
Incident: any malfunction or alteration of the characteristics or performance of a device made available 
on the market, including an error in use due to ergonomic features, as well as any defect in the information 
provided by the manufacturer and any undesirable side effects. 
 
Serious incident: any incident that has directly or indirectly caused, likely to have resulted or likely to 
result in:  
- 
The death of a patient, user, or any other person,  
- 
A serious deterioration, temporary or permanent, in the state of health of a patient, a user or any 
other person, 
- 
A serious threat to public health. 
C. EVENTS, SERIOUS ADVERSE REACTIONS, SERIOUS ADVERSE REACTIONS TO THE 
DEVICE, SERIOUS UNEXPECTED ADVERSE REACTIONS TO THE DEVICE, PUBLIC 
HEALTH THREATS 
See Chapter B.  
D. LIST OF UNDESIRABLE REACTIONS THAT MAY NOT BE REPORTED 
Only events that are not causally related (see below) to the device being investigated, comparator, or 
investigation procedure may not be reported to SERF.  
Causality is determined by the definitions below: 
 
Unbound 
- 
No temporal link,  
- 
Does not follow a known and biologically improbable DM reaction pattern, 
- 
Interruption/reduction and reintroduction does not affect SAE, 
- 
Site or organ not affected by the MD or procedure, 
- 
Other cause identified, 
- 
SAE not related to a misdiagnosis result by the MD in HF. 
Possible 
Weak link but cannot be totally excluded (includes cases for which causality cannot be 
assessed or no information could be obtained) 
Probable 
The link seems relevant and/or no other cause can explain the SAE 
Causal 
link 
- 
Temporal link, 
- 
Known side effect for this category of MD or this type of procedure, 

 
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- 
Known DM reaction pattern, 
- 
Site or organ affected by the MD or procedure, 
- 
Interruption/reduction and reintroduction affects SAE, 
- 
Possible other causes have been excluded, 
- 
SAE due to a user error, 
- 
SAEs related to a misdiagnosis result by the MD in HF. 
 
In all other cases: 
- 
Any serious adverse event (SAE) with a proven or reasonably foreseeable causal link; 
- 
Any defect or malfunction or incident of a device that could have resulted in a SAE in the 
absence of appropriate measures or intervention, or if the circumstances had been less 
favourable; 
- 
Any new information concerning the 2 previous points,  
The investigator reports the complication to the sponsor according to the deadlines and procedures 
provided for below. 
E. REPORTING DEADLINES  
F. DETAILS OF THE ADVERSE EVENT REPORTING PROCESS 
For unrelated adverse events (see Chapter 14.D), the investigator enters the complication directly in the 
report form.  
In all other cases (adverse effects), the investigator completes the dedicated form (see Appendix 4) 
present in the patient's observation form, taking care to transmit all the requested information relating to 
the complication. The investigator forwards the form to the person in charge of the study at SERF, whose 
contact details are specified in the chapter I below and within the time limits (see above). The form can 
be sent either by fax or by email (form scanned legibly). 
Any information concerning the evolution (resolution, worsening of the patient's condition, etc.) of a 
reported event must also be sent to the person in charge of the study at SERF via the complication 
declaration form.  
 
If, for any reason, an adverse reaction (of any kind) is identified during monitoring and has not been 
reported to SERF, the adverse event reporting form will be completed from the patient's medical record 
or case report form if the information is included.  
Event 
MDR Article 
Method 
of 
notification 
Time 
limit 
for 
notification 
to 
the 
sponsor 
Unrelated AE  
NA 
In 
the 
case 
report book 
No immediate notification 
SAEs with a plausible or proven 
causal link to risk of death/serious 
illness or injury 
Art.80 
Declaration form 
Immediate 
notification 
and within a maximum of 
3 days  
SAEs with a plausible or proven 
causal relationship with no risk of 
death/serious illness or injury 
Art.80 
Declaration form 
Follow-up of any previously reported 
events 
Art.80 
Declaration form 
Serious incident  
Arts 87 to 90 
Declaration form 

 
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SERF will record on the database of each study the adverse events of the patients participating in the 
study.  
G. DETAILS OF THE DEVICE DEFECT REPORTING PROCESS 
This study is an observational study. The reports of defects in the device under study were made by each 
centre according to their usual procedure.  
However, as part of the medium-term follow-up (minimum 4 years postoperative years) of this HF, any 
defect in the device must be communicated to SERF by the investigator who fills in the dedicated form 
present in the patient's observation form. The investigator sends the form to the person in charge of the 
study at SERF, whose contact details are specified in Chapter I. The form can be sent either by fax or by 
email (form scanned legibly). 
H. LIST OF FORESEEABLE ADVERSE EVENTS AND EXPECTED ADVERSE REACTIONS OF 
THE DEVICE 
Known adverse events and reactions related to hip replacement and SAGITTA® EVL R implantation are 
listed in Chapter 4. 
The respective incidences and means of treatment of these complications are known and listed in the 
clinical evaluation of the device, available upon request.  
I. EMERGENCY CONTACT INFORMATION 
All serious or non-serious and/or unexpected adverse events and effects related to the device must be 
reported via the dedicated form, contained in the CRF, to the person in charge of the investigation within 
the SERF clinical department: 
Lydie BONNEVAY 
Fax: 04.72.02.19.18 
Email: clinical@serf.fr  
J. INFORMATION RELATED TO THE DATA MONITORING COMMITTEE IF ESTABLISHED 
Not applicable, no data monitoring committee has been established as part of this investigation due to its 
observational nature. 
15. 
VULNERABLE POPULATION 
A. DESCRIPTION OF THE VULNERABLE POPULATION TO BE INCLUDED 
No vulnerable populations are planned to be included for this clinical investigation.  
B. DESCRIPTION OF THE SCREENING PROCESS TO IDENTIFY AND PROTECT 
VULNERABLE POPULATIONS 
No vulnerable populations are planned to be included for this clinical investigation.  

 
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C. DESCRIPTION OF THE SPECIFIC PROCESS FOR OBTAINING INFORMED CONSENT  
No vulnerable populations are planned to be included for this clinical investigation.  
D. DESCRIPTION OF THE SPECIFIC RESPONSIBILITY OF THE ETHICS COMMITTEE 
Not applicable. 
E. DESCRIPTION OF ANY MEDICAL CARE PROVIDED TO SUBJECTS AFTER HF IS 
COMPLETED 
Refer to Chapter 6.D. 
16. 
PREMATURE TERMINATION OR SUSPENSION OF THE CI 
A. CRITERIA AND PROVISIONS FOR PREMATURE TERMINATION OR SUSPENSION OF 
CLINICAL INVESTIGATION FOR THE ENTIRE INVESTIGATION OR FOR ONE OR MORE 
SITES 
i. 
FOR THE ENTIRE INVESTIGATION 
For reasons of safety of the subjects, in particular in the event of suspension of CE marking for a device, 
resulting in an unacceptable benefit/risk balance, the investigation will be closed prematurely. 
ii. 
FOR ONE OR MORE CENTRES 
- 
At the initiative of the center or the investigator: 
o 
Change of the investigating team that does not allow the continuation of the study and the 
follow-up of the subjects; 
o 
Force majeure (death of the investigator, climatic incidents, etc.) 
In this case, the investigator will forward all relevant documentation to SERF. 
 
- 
At the initiative of the promoter:  
o 
Study progress not respected. 
o 
Major deviations from protocol and/or regulations and good clinical practices.  
o 
Inability of the investigator to include subjects according to the planned schedule. 
o 
Lack of patient consent.  
B. CRITERIA FOR SETTING UP AND BREAKING THE BLINDING CODE DUE TO 
SUSPENSION OR EARLY TERMINATION OF IC 
Not applicable, the IC is conducted in open-label. 
C. SUBJECT TRACKING REQUIREMENT 
Any subject with an adverse event should be followed until resolution or stabilization of the event.  
In all cases (exclusion of the patient from the investigation, premature termination of HF, withdrawal of 
consent, etc.), the investigator continues to monitor the subject and provide appropriate medical care for 
his condition. 

 
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17. 
PUBLICATION POLICY 
A. REGISTRATION OF THE STUDY IN A PUBLICLY AVAILABLE DATABASE 
This clinical investigation will be registered on the EUDAMED database when it is functional, as well as 
on the public database (ClinicalTrials.gov). 
B. STATEMENT THAT THE RESULTS WILL BE PUBLICLY AVAILABLE 
This study may be published. If this is the case, it is envisaged that the preparation of the publication(s) 
will be carried out by the investigators. 
Nevertheless, the results of this study are intended for SERF for the monitoring of its medical devices. In 
accordance with the legislation in force, it will be possible for the subjects participating in the study to be 
communicated the results of the investigation to them. The results will be published on the EUDAMED 
database when it is functional. 
C. STATEMENT OF THE CONDITIONS UNDER WHICH CI RESULTS WILL BE PUBLISHED 
If there is a publication of the results, all information provided to the investigator by SERF is strictly 
confidential. The investigator agrees to use the information to perform the investigation but not for any 
other purpose without the written permission of SERF. It is understood that it is mandatory to provide 
SERF with all the data obtained during the investigation. 
The information obtained from the CI may be used for further development and may be disclosed to health 
authorities, other investigators and SERF's designated partners as needed. 
These publications will be developed and the list of authors will be determined in accordance with the 
Harvard Guidelines which state that each author must have a substantial and direct intellectual 
contribution to the work carried out (Authorship Guidelines): 
http://www.hms.harvard.edu/fa/guide 
With the recommendations of the ICMJE (International Committee of Medical Journal Editors) which 
indicate that each author must:  
1) have made a significant contribution to the conception and design of the study, to the collection of data, 
or to the analysis, or interpretation of the data,  
2) have participated in the writing of the article or in its proofreading, and  
3) have given their consent for publication.  
 
The main clinical results, intermediate and final, may be reported at the meetings of the national learned 
societies and published in the most appropriate international journal. Authors will include the principal 
investigators, the project methodologist, members of the scientific council, and the local investigators most 
involved in the project. All investigators will be reported in the list of investigators of the investigation. 
In addition, the promoter and the funder(s) of the study will be mentioned in the publications relating to 
this study. 
18. 
BIBLIOGRAPHY 
 
 

 
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APPENDIX 1: LIST AND QUALIFICATIONS OF INVESTIGATORS 
Name and 
surname 
Function 
Department 
and hospital  
Address 
Email 
Telephone 
RPPS 
Number 
Prof. 
DUJARDIN 
Franck 
Orthopedic 
Surgeon 
Rouen 
University 
Hospital Charles 
Nicolle Hospital 
37 boulevard 
Gambetta 
76000 Rouen 
franck.dujardin@chu-
rouen.fr 
0232888007 
10 001 915 734 
 
 
 

 
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APPENDIX 2: PRODUCT INSTRUCTION LEAFLET UNDER REVIEW 
 
 
 

 
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APPENDIX 3: INFORMATION LETTER ON 
 
 
 

 
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APPENDIX 4: SRIA-CIDT REPORTING FORM 
 
 
 

 
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APPENDIX 5: HARRIS HIP SCORE 
 
PAIN 
 
No 
44 
 
Light, occasional, no limitation of activities 
40 
 
Moderate, no effect on daily activities, may occur 
after unusual activity, use of minor analgesics 
30 
 
Moderate, tolerable, some limitations in ordinary 
activities or at work, taking stronger painkillers   
20 
 
Severe pain, severe limitation of activities 
10 
 
Totally disabled, permanent pain even in bed 
0 
 
 
LIMP 
 
No 
11 
 
Light 
8 
 
Moderate 
5 
 
Severe or unable to walk 
0 
 
 
SUPPORT 
 
None 
11 
 
Rod for long walks 
7 
 
Cane most of the time 
5 
 
A crutch/cane 
3 
 
Two rods 
2 
 
Two canes or unable to walk 
0 
 
 
MARKET SCOPE 
Unlimited 
11 
 
30 minutes 
8 
 
10 – 15 minutes 
5 
 
In the house 
2 
 
From bed to chair 
0 
 
 
ACTIVITIES (shoes, socks) 
With ease 
4 
 
With difficulties 
2 
 
Total incapacity 
0 
 
 
 
 
 
 
 
 

 
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STAIRS 
Normal, without using the ramp 
4 
 
Normal, using the ramp 
2 
 
Possible but unorthodox 
1 
 
Impossible 
0 
 
 
TRANSPORT PUBLIC 
Able to use transport 
1 
 
Unable to use transport 
0 
 
 
SEATED 
Comfortably in a chair for 1 hour 
5 
 
On a chair for 30 minutes 
3 
 
Unable to sit comfortably in a chair 
0 
 
 
ABSENCE OF VICIOUS ATTITUDES 
(4 "Yes" = 4 points; Less than 4 "Yes" = 0 points) 
 
< 30° flessum 
Yes 
 
No 
 
< 10° adductum 
Yes 
 
No 
 
< 10° internal rotation 
Yes 
 
No 
 
Length inequality< 3.2 cm 
Yes 
 
No 
 
 
MOBILITY 
(* Standard amplitude) 
300° - 211° 
210° - 161° 
160° - 101° 
100° - 61° 
61° - 30° 
30° - 0° 
Points 
5 
4 
3 
2 
1 
0 
 
Bending (*140°) 
 
 
 
 
 
 
Abduction (*40°) 
 
 
 
 
 
 
Supply (*40°) 
 
 
 
 
 
 
Belch. External (*40°) 
 
 
 
 
 
 
Belch. Internal (*40°) 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX 6: FORGOTTEN HIP SCORE – SHO12 
 
 
1pt 
2pts 
3pts 
4pts 
5pts 
Are you aware of your hip... 
Never 
Hardly 
ever 
Rarely 
Sometimes 
Often 
1. … in your bed at night? 
☐ 
☐ 
☐ 
☐ 
☐ 
2. … When you sit in a chair for more than 
an hour? 
☐ 
☐ 
☐ 
☐ 
☐ 
3. … When you walk for more than 15 
minutes? 
☐ 
☐ 
☐ 
☐ 
☐ 
4. … when you take a bath or shower? 
☐ 
☐ 
☐ 
☐ 
☐ 
5. … When you travel by car? 
☐ 
☐ 
☐ 
☐ 
☐ 
6. … When you climb the steps of a 
staircase? 
☐ 
☐ 
☐ 
☐ 
☐ 
7. … When you walk on uneven ground? 
☐ 
☐ 
☐ 
☐ 
☐ 
8. … When you get up from a low sitting 
position? 
☐ 
☐ 
☐ 
☐ 
☐ 
9. … When you stand for a long time? 
☐ 
☐ 
☐ 
☐ 
☐ 
10. … When you do housework or 
gardening? 
☐ 
☐ 
☐ 
☐ 
☐ 
11. … When you are walking or hiking? 
☐ 
☐ 
☐ 
☐ 
☐ 
12. … when you practice your favorite 
sport? 
☐ 
☐ 
☐ 
☐ 
☐ 
12b... during your sexual intercourse? 
☐ 
☐ 
☐ 
☐ 
☐ 
 
 
 
 

 
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APPENDIX 7: ENGH SCORE 
 
Fixation 
Appearance of a 
porous border 
 Extensive≥ 50%  
−5 pts 
 Indeterminate 
0 pt  
 None 
+5 pts 
Bone Bridges 
 Absence 
−2.5 pts 
 Indeterminate 
0 pt 
 Presence 
+5 pts 
Score 
………./ 10 
Stability 
Appearance of a 
smooth border 
 Extensive≥ 50% 
−3.5 pts 
 Indeterminate 
 0 pt 
 None 
+5 pts 
Pedestal if distal 
part not locked 
 Presence 
−3.5 pts 
 Indeterminate 
 0 pt 
 Absence 
+2.5 pts 
Calcar 
modification 
 Hypertrophy 
−4 pts 
 Indeterminate 
 0 pt 
 Atrophy 
+3 pts 
Edging 
 Presence 
−2.5 pts 
 Indeterminate 
 0 pt 
 Absence 
+2.5 pts 
Migration >5mm 
 Presence 
− 5 pts 
 Indeterminate 
 0 pt 
 Absence 
+3 pts 
Appearance 
of 
metal particles 
 Presence 
− 5 pts 
 Indeterminate 
 0 pt 
 No 
+1 pt 
Score 
………../ 17 
Total Score (Fixation + Stability) .. ……../ 27