A Single Center Post-market Clinical Follow-up (PMCF) Observational Study Evaluating the Clinical Performance and the Safety Profile of the JuniOrtho™ Telescopic Intramedullary Nail (JTIN) for the Treatment of Pediatric Patients Suffering From Osteogenesis Imperfecta
Conditions: Osteogenesis Imperfecta
Sponsor: Orthofix s.r.l.

Study code: OCI_2201
Protocol date: 02/08/2024
Protocol version: 1.1
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Post-Market Clinical Follow-up Observational Study Protocol
Protocol OCI_2201 Version 1.1 02/08/2024
Study code: OCI_2201
A single center post-market clinical follow-up (PMCF) observational 
study evaluating the clinical performance and the safety profile of the 
pediatric patients suffering from Osteogenesis Imperfecta
ClinicalTrials.gov ID: NCT05612139
Confidential Material
The information in this document is the property of Orthofix S.r.l. and is confidential. Neither the document 
nor the information contained therein be reproduced or disclosed outside Orthofix S.r.l. without the written 
consent of the company.

Study code: OCI_2201
Protocol date: 02/08/2024
Protocol version: 1.1
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PROTOCOL AUTHORS / CONTRIBUTORS SIGNATURES PAGE 
Tommaso Marano, Author
Clinical Research Coordinator
Orthofix srl
Signature
Date 
Doris Barnier-Ripet, Contributor
Regulatory Project Manager
Axonal
Signature
Date
Daniela Cangiano, Reviewer
Clinical Program Manager
Orthofix srl
Signature
Date 

Study code: OCI_2201
Protocol date: 02/08/2024
Protocol version: 1.1
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INVESTIGATOR SIGNATURE PAGE
By my signature below, I acknowledge that I have read this protocol and I agree that it contains 
all necessary details for carrying out the study described therein. Furthermore, I agree to 
conduct this study in compliance with said study protocol, the ICH Good Clinical Practice 
guideline and ISO 14155, as well as with any applicable national or local laws and regulations 
and with my contractual obligations towards Orthofix S.r.l. or its representatives.
Site code: FRA01
Principal Investigator: 
Dr. Zagorka Pejin
Orthopedic Surgeon at Chirurgie orthopédique et traumatologie 
pédiatrique
______________________________       __________________
Signature
Date
Site contact details:
Investigation site: Necker-Enfants Malades Hospital
Address: 149 rue de Sèvres, 75015 Paris - France
Phone: +33 1 44 49 40 00 (Hospital Landline)
            +33 1 44 49 42 07 (Chirurgie orthopédique et traumatologie pédiatrique)
Fax:      +33 1 44 49 42 40
Unit Email: rdv.orthopedie@nck.aphp.fr
PI Email: zagorka.pejin@aphp.fr

Study code: OCI_2201
Protocol date: 02/08/2024
Protocol version: 1.1
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1.
CONTACT INFORMATION
Sponsor 
Orthofix S.r.l., 
Via Delle Nazioni 9
37012 Bussolengo (Verona), Italy
Contact Person: Edo Knijff
email: edoknijff@orthofix.it
Office landline: (+39) 045 6719 000
SAE Reporting
& Safety Related Issues
safetyclinicalstudiesintl@orthofix.com
Device Deficiency & 
Complaint Reporting
complaintintl@orthofix.com
CRO
High Research S.r.l
Viale Abruzzi 13/a
20131 Milan, Italy
Contact person: Marina Chiesa
email: m.chiesa@evidenze.com
Phone: (+39) 02 66712580
Local CRO
Axonal
215 avenue Georges Clemenceau
92000 Nanterre, France
Contact person: Marie-Lou Camut
Email: mlcamut@axonal.com
Phone: +33 (0)1 56 38 21 50
Project Manager 
Tommaso Marano
Address: 
Via delle Nazioni 9, 37012 
Bussolengo, Italy
Phone:
(+39) 045 6719 000
Email:
tommasomarano@orthofix.it
Fax:
(+39) 045 6719 380

Study code: OCI_2201
Protocol date: 02/08/2024
Protocol version: 1.1
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2.
TABLE OF CONTENTS
1.
CONTACT INFORMATION.......................................................................................................... 4
2.
TABLE OF CONTENTS ............................................................................................................... 5
3.
LIST OF ABBREVIATIONS ......................................................................................................... 7
4.
SYNOPSIS.................................................................................................................................... 8
4.1
Visits and Assessments Schedule .............................................................................. 12
4.2
Schematic Diagram ..................................................................................................... 13
5.
INTRODUCTION ........................................................................................................................ 14
5.1
Background Information .............................................................................................. 14
5.2
Rationale of the study.................................................................................................. 15
6.
STUDY OBJECTIVES................................................................................................................ 16
6.1
Primary Objective ........................................................................................................ 16
6.2
Secondary Objectives ................................................................................................. 16
6.3
Exploratory Objectives ................................................................................................ 16
7.
STUDY DESIGN......................................................................................................................... 17
7.1
Research Type ............................................................................................................ 17
7.2
Subjects and Sites Numbers....................................................................................... 17
7.3
Study duration ............................................................................................................. 17
7.4
Measures to Minimize or Avoid Bias ........................................................................... 18
7.4.1
Blinding and Randomization ........................................................................ 18
7.4.2
Subject Identifier .......................................................................................... 18
7.5
End of Study (EOS)..................................................................................................... 18
8.
SELECTION AND WITHDRAWAL OF SUBJECTS.................................................................. 19
8.1
Subject Inclusion Criteria............................................................................................. 19
8.2
Subject Exclusion Criteria ........................................................................................... 19
8.3
Subject Withdrawal...................................................................................................... 19
9.
TREATMENT OF SUBJECTS ................................................................................................... 21
9.1
Study Investigational Product...................................................................................... 21
Configurations or variants........................................................................................................... 22
Key functional elements.............................................................................................................. 22
Implantable devices..................................................................................................... 22
9.1.1
Packaging and Labelling.............................................................................. 23
9.1.2
Investigational Products Accountability and Storage................................... 23
9.2
Concomitant Treatments and Rescue Medications .................................................... 24
9.2.1
Permitted Concomitant Treatments (Medications and Therapies) .............. 24
9.2.2
Contraindications according to Manufacturer IFU ....................................... 24
10.
STUDY PROCEDURES ............................................................................................................. 25
10.1
Description of Procedures ........................................................................................... 25
10.2
Visits Description ......................................................................................................... 25
10.2.1
Visit 0 - Screening........................................................................................ 25
10.2.2
Visit 1 - Surgery (Day 0)............................................................................... 26
10.2.3
Visit 2 - Discharge (1 week ± 2 days) .......................................................... 26
10.2.4
Visit 3 - Plaster or Immobilizer Removal (2 months ± 2 weeks) .................. 26
10.2.5
Visit 4 - Bone Consolidation Assessment (5 months ± 2 months)............... 26
10.2.6
Visit 5 - 2nd Follow-up Visit (9 months ± 1 month)........................................ 26
10.2.7
Visit 6 - 3rd Follow-up Visit (1 year ± 1 month)............................................. 26
11.
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ....................................................... 27
11.1
Adverse Events ........................................................................................................... 27

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11.1.1
Definition of Adverse Event (AE) ................................................................. 27
11.1.2
Definition of Serious Adverse Event (SAE).................................................. 27
11.1.3
Definition of Adverse Device Effect (ADE)................................................... 28
11.1.4
Definition of Serious Adverse Device Effect (SADE)................................... 28
11.1.5
Possible Adverse Device Effect according to Manufacturer IFU ................. 28
11.1.6
Possible ADE incidence, mitigation, and treatment ..................................... 28
11.1.7
Relationship between an AE/SAE and the use of the medical device......... 29
11.1.8
Medical Device Deficiency (MDD) ............................................................... 30
11.1.9
Incident......................................................................................................... 30
11.1.10
Procedures for Reporting and Recording AE, SAE and Medical 
Device Deficiencies...................................................................................... 30
11.1.11
Notification deadlines................................................................................... 31
Notification to Authorities ............................................................................................................ 31
12.
STATISTICS ............................................................................................................................... 32
12.1
Statistical and Analytical Plans.................................................................................... 32
12.1.1
Population(s) of analysis.............................................................................. 32
12.1.2
Efficacy, Safety and Other Variables ........................................................... 32
12.1.2.1
Efficacy Variables .................................................................... 32
12.1.2.2
Safety Variables ...................................................................... 33
12.1.2.3
Other Variables........................................................................ 33
All variables reported in the Table above (Section 4.1) will be included, as per 
scheduling assessment................................................................................ 33
12.2
Statistical Evaluation ................................................................................................... 33
12.2.1
Evaluation of Safety ..................................................................................... 33
12.2.2
Evaluation of Efficacy................................................................................... 33
12.2.3
Exploratory Analyses ................................................................................... 33
12.3
Determination of the Sample Size............................................................................... 34
12.4
Interim Analysis ........................................................................................................... 34
12.5
Dictionaries.................................................................................................................. 34
13.
ETHICS AND REGULATORY REQUIREMENTS ..................................................................... 35
13.1
Approval ...................................................................................................................... 35
13.2
Subject Information and Non-opposition ..................................................................... 35
13.3
Subject Confidentiality................................................................................................. 36
14.
STUDY MANAGEMENT AND ADMINISTRATION ................................................................... 37
14.1
Supplies....................................................................................................................... 37
14.2
Monitoring.................................................................................................................... 37
14.3
Direct Access to Source Data/Documents .................................................................. 37
14.4
Audit and Inspection.................................................................................................... 37
14.5
Adherence to Protocol................................................................................................. 38
14.6
Data Handling and Retention ...................................................................................... 38
14.7
Clinical Study Report................................................................................................... 39
14.8
Insurance and Liability................................................................................................. 39
14.9
Financial Disclosure .................................................................................................... 39
14.10
Publication ................................................................................................................... 39
15.
REFERENCES ........................................................................................................................... 41
16.
APPENDICES............................................................................................................................. 43
16.1
Appendix 1: Investigational Device items catalog number.......................................... 43
List of Figures
Figure 4:1
Study schematic diagram....................................................................................... 13

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3.
LIST OF ABBREVIATIONS
ADE
Adverse Device Effect
AE
Adverse Event
ASADE
Anticipated Serious Adverse Device Effect
CE
Conformité Européenne (European Conformity)
CRF
Case Report Form
CRO
Contract Research Organization
CV
Curriculum Vitae
GCP
Good Clinical Practice
GP
General Practitioner
ICH
International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use
IEC
Independent Ethics Committee
JTIN
MDDs
Medical Device Deficiencies
MDR
Medical Device Regulation (EU 2017/745)
OT
Operative Technique
OI
Osteogenesis Imperfecta
PMCF
Post-Market Clinical Follow-up
IFU
Instruction for Use
ITT
Intention-To-Treat
PP
Per-Protocol
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SDV
Source Data Verification
TMF
Trial Master File
ROM
Range of Motion
SOA
State-of-art
USADE
Unanticipated Serious Adverse Device Effect
WBP
Weight Bearing Protocol

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4.
SYNOPSIS
TITLE
A single center post-market clinical follow-up (PMCF) observational 
study evaluating the clinical performance and the safety profile of the 
for the treatment of 
pediatric patients suffering from Osteogenesis Imperfecta
ACRONYM
JTIN
RATIONALE
This study has been planned as part of the Orthofix Srl post-market 
active surveillance plan for the collection of data on both the clinical 
performance and the safety profile of the JTIN. 
The rationale of the proposed study is to update and support the pre-
market clinical evaluation of the JTIN with Real World Evidence 
clinical data in a real-life surgical setting, in order to confirm the 
benefit/risk ratio of this medical device and to keep the CE mark under 
Medical Device Regulation (MDR) requirements.
INVESTIGATIONAL 
DEVICE
.
The JTIN is a self-extending intramedullary nail (telescopic rod) 
designed to address the specific demands of osteosynthesis in 
pediatric patients suffering from osteogenesis imperfect (OI). It is 
intended for the fixation of femoral and/or tibial fractures, osteotomies, 
malunions and non-unions. The design of the JTIN includes a female 
and a male component, which are anchored to the proximal cortex 
and distal epiphysis through screw-type fixation in femurs, and fixation 
in proximal and distal epiphysis in tibias. These two components slide 
from each other, allowing for extension of the JTIN as the bone 
structures remodel and patient growth occurs.
PROCEDURES
One selected site, experienced in the treatment of pediatric patients 
with OI, where the usage of JTIN is already part of the normal clinical 
practice, will participate in this study. Investigator will screen patients
treated (or planned to be treated) with JTIN to verify inclusion and 
exclusion criteria, to achieve the enrollment of 25 cases. With lost to 
follow-up percentage estimated at 20%, this will lead to a total of 20
evaluable cases, i.e. 20 implanted JTIN (some patients may 
contribute for more than one implant). Patients are prospectively and 
retrospectively enrolled in the study: they may have undergone JTIN 
implantation from the 1st of January 2022.
Enrolled patients, since this study is non-interventional and 
observational, will follow the standard medical practice of the site: no 
requirements regarding the treatment of patients will be imposed on 
the site or Principal Investigator and the Sponsor will not in any 
manner influence the treatment decisions. Data of enrolled subjects 
will be collected for this study up to 1 year from surgery.
The hospital standard care usually, but not exclusively, includes:
surgery, discharge and plaster removal visits, and then 3 other follow 
up visits up to 1 year from surgery (see
S
Visits frequency is estimated as average of the site 
normal clinical practice, actual visit timing for each patient will be 
performed according to investigators and hospital staff evaluation.
The patient data will be systematically collected by the investigator in 
eCRF. 
PLANNED
INVESTIGATION PERIOD
Preparation:
4 months for ethics committee submission preparation and approval.

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Enrolment period:
6 months from site initiation.
Live phase:
Total of 1,5 year (18 months), i.e. 6 months of enrollment period plus 
1 year of clinical data collection until the last patient completed follow-
up.
Final phase:
6 months including final monitoring, database closure and Statistical 
and Clinical Study Report writing.
OBJECTIVES
Primary objective: to evaluate the safety of the JTIN, in terms of
percentage of procedures with at least one serious/not serious 
adverse event certainly or possibly related to JTIN up to 1 year follow-
up.
Secondary objectives: to evaluate clinical safety and performance of 
the JTIN, in terms of: implant survival for safety, bone union 
achievement and fracture-free survival for performance.
Exploratory objective: The Gillette Functional Assessment 
Questionnaire will be collected at different times to evaluate the 
changes after treatment.
TYPE OF THE 
INVESTIGATION
This study on JTIN device is a post-market, prospective and 
retrospective, observational, single-center study, namely a PMCF 
study. The design will contain a single arm, will be open label and will 
not involve randomization nor any additional procedure compared to 
routine practice.
PLANNED INVESTIGATION 
PERIOD 
First patient
First visit
Q3
2023
Last patient
First visit
Q3 
2023
Last patient
Last visit
Q4
2024
STUDY DURATION PER 
SUBJECT
The Study initiation for the subject is to be intended after patient's 
information and non-opposition (that can be also after the JTIN 
application surgery). The subject will be treated by the means of JTIN 
application and will follow standard clinical care of the selected site. If 
the information and non-opposition occur after the JTIN surgery,
previous data will be collected retrospectively. The data from the 
standard care will be collected for this study up to 1 year follow-up 
visit.
CENTER(S)
/ COUNTRY(IES) 
Hospital
Country 
(EU)
City
Principal Investigator
1
France
Paris
Dr. Zagorka Pejin
PATIENTS / GROUPS
Clinical data will be collected only on patients with a regular indication 
for JTIN as per IFU (no off-label use will be included). The JTIN is 
indicated for fractures, osteotomies, malunions and non-unions in 
femur and tibia in pediatric patients suffering from osteogenesis 
imperfecta. The JTIN is intended to be used in pediatric patients, older 
than 18 months.
INCLUSION CRITERIA
A patient will be included in the study if:
is in pediatric age ((> 18 month and < 18 years) at the time of 
surgery;
is skeletally immature;
has a diagnosis for OI;

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has a regular indication for surgical intervention with JTIN to 
treat femoral and/or tibial fractures, osteotomies, malunions 
and non-unions;
Patient and/or legal representative/guardian is duly informed 
.
EXCLUSION CRITERIA
A patient will not be included in the study who:
has a medical condition that is a contraindication according to 
has any 
interfere with the study execution or due to which the patient 
should not participate for safety reasons;
requires the application of, or has already in-situ concomitant 
devices that cannot be safely removed (except for permitted 
concomitant devices);
is participating in other clinical trial or has taken part in any 
clinical study in the last 3 months with exception of analytical 
trials on genetics study related to OI (i.e. studies that do not 
include an investigational treatment for the patient such as 
new drugs or other medical devices);
is likely to be lost to follow up
opinion.
CONCOMITANT 
MEDICATION/CON-
COMITANT DEVICE
K-wires, bone graft and any other concomitant devices, e.g. bone 
screws, that were applied to fix any bone fragments but that were not 
considered critical for the maintenance of treated bone alignment, are 
permitted during the treatment. It is understood that any necessary 
medical devices applied on any other bones other than the one 
treated by JTIN are permitted as well.
SAFETY ENDPOINTS
Safety endpoints: The safety profile of JTIN will be assessed by the 
following safety endpoints:
Percentage (%) of procedures with at least one serious/not 
serious adverse event certainly or possibly related to JTIN up 
to 1 year follow-up (primary);
Implant survival rate: it is the percentage of not exchanged 
nails up to 1 year follow-up.
EFFICACY ENDPOINTS
Efficacy endpoints: the clinical performance of the JTIN will be 
assessed by the means of the:
Bone union achieved;
Post-treatment fracture-free survival up to 1 year follow-up;
EXPLORATORY 
ENDPOINT
Gillette Functional Assessment Questionnaire will be collected before 
the surgery and then at bone consolidation assessment and at 1 year 
follow-up. 
CLINICAL PARAMETERS
Age at surgery
Gender, height, weight
OI classification
Co-morbidities (other acquired or congenital deformities) and 
family diseases history
Concomitant Medication, if applicable
Treated Bone/s (femur / tibia)
Surgery details (operation time, fluoroscopy time, device 
variant, other devices, complications
including blood loss)
Intraoperative measures (for corrections):
o
Number of osteotomies
o
Rotational correction
o
Varus / valgus correction
o
Shortening

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Postoperative radiographic measures to assess any 
deviations from intraoperative measures
ROM and WBP
Bone union assessment
Safety events (AE and MDD)
STATISTICAL 
METHODOLOGY FOR 
SAMPLE SIZE 
CALCULATION
A revision of the literature on the complication rates has been made. 
The scientific literature reports that the percentage of procedures 
which develop at least one serious/not serious adverse event certainly 
or possibly related to the procedure itself is between 9% and 60%, 
with a mean of 31%. Assuming a complication rate aligned or better 
than the mean observed in literature (31%), but also considering 
alignment
rate (bone 
union), a sample size of 20 procedures will be sufficient to estimate 
the adverse event rate with 95% confidence interval of the upper limit 
fund in literature. Considering a drop-out or a non-evaluable rate of 
20% of the procedures, a total of 25 procedures should be collected 
for this study.

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5.
INTRODUCTION
A manufacturer of a medical device must demonstrate that the intended purpose(s) and 
claim(s) made in relation to safety and performance of a medical device are achieved. As a 
general rule, such demonstration will require clinical data. Clinical data are relevant to the 
various aspects of the clinical safety and performance of the device. This may include data 
from prospective and retrospective clinical investigations of the concerned device as well as 
market experience of the same or equivalent devices and medical procedures and information 
from the scientific literature.
The aim of the present study is to collect post-market clinical evidence (post-market clinical 
follow up PMCF) on the use of the medical device JuniOrtho
Telescopic Intramedullary Nail 
(JTIN).
This document is a PMCF study protocol for a human research study to be conducted 
according to the last update of: international standard ISO 14155, the European Community 
guideline on Good Clinical Practice (CPMP/ICH/135/95, ICH-E6, ICH-E11), MDR 2017/745, 
GDPR- 679/2016, declaration of Helsinki, local applicable regulations and any further update.
5.1
Background Information  
Osteogenesis Imperfecta (OI), also called brittle bone disease, is a group of genetic disorders 
that affect connective tissue due to a lack of type I collagen. The classical Sillence types of OI 
(types I-IV) with autosomal dominant inheritance comprise about 80-85% of cases and are 
caused by mutations in the genes that encode type I collagen, COL1A1 and COL1A2. 
Osteogenesis imperfecta is a very polymorphic condition, apart from the classical autosomal 
dominant forms, there are also recessive forms, often severe. Forms with hyperthrophic 
calluses (type V DA), and others associated with joint contractures (Bruck's syndrome). 
Currently, more than twenty affections are identified clinically and by molecular biology 
studies. The incidence of forms recognizable at birth is 1:10-20,000. The hallmark feature of 
OI is bone fragility, with susceptibility to fracture from minimal trauma, as well as bone 
deformity and growth deficiency. Secondary features include dentinogenesis imperfecta (DI), 
cardiopulmonary complications and, in adult years, hearing loss. The clinical features of OI 
represent a continuum ranging from perinatal lethality to individuals with severe skeletal 
deformities, mobility impairments, and very short stature to nearly asymptomatic individuals 
with a mild predisposition to fractures, normal dentition, normal stature, and normal life span. 
Fractures can occur in any bone but are most common in the limbs.
Management is ideally done by a multidisciplinary team including specialists in medical 
management of OI, clinical genetics, orthopedics, endocrinologist, rehabilitation medicine, 
paediatric dentistry, otology/otolaryngology, and mental health.
Intramedullary nails have an important role for bone stabilization and fracture prevention in 
patients with OI, who suffer from bone fragility and recurrent fractures. Long bones in the lower 
limbs of OI patients are especially prone to deformities that develop as a result of bone 
deformability or from malunion in fractures. Thus, it is important to provide structural support 
to the weakened bones of these patients, which is better accomplished with the use of 
intramedullary devices.
The objectives of long bone rodding in OI patients are to:
-
Fracture treatment;
-
Correct deformity;

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-
Improve function;
-
Restore bone density through functional load bearing. 
5.2
Rationale of the study
Orthofix Srl put the JTIN on the European market (2021) by the mean of a pre-market clinical 
evaluation made under the Medical Device Directive (MDD) requirements that was based on 
the analysis of the scientific literature of equivalent devices. 
This study has been planned as part of the Orthofix Srl post-market active surveillance plan 
for the collection of data on both the clinical performance and the safety profile of the JTIN in 
a representative population of patients and users. 
The rationale of the proposed study is to update and support the pre-market clinical evaluation 
of the JTIN with real-word-evidence clinical data, in order to confirm the benefit/risk ratio of 
this medical device and to keep the CE mark under Medical Device Regulation (MDR) 
requirements.
The uniqueness of the pediatric population manifests itself in specific indications for lower 
extremity reconstruction, due to osteogenesis imperfecta; different approach in compliance 
with operative and postoperative care in addition to need for adaptability to rapid growth and 
development. The 
Telescopic Intramedullary Nail (JTIN) is an established, 
marketed device, commercially available and used as standard device in orthopedic surgeries.  
The post-marketing, prospective study with CE-
Telescopic 
Intramedullary Nail (JTIN) is designed for gathering real-world medical data from treatment of 
fractures, osteotomies/ bone deformities, malunions and non-unions in femur and tibia in 
pediatric patients (older than 18 months) suffering from osteogenesis imperfecta.
All data will be gathered from standard medical documentation from patients who have already 
been successfully treated with JTIN. Additionally, all procedures that patients underwent are 
justified by standard of care. 
Constant identification of serious or unexpected serious risk related to the use of the device, 
especially in real-world experience may bring additional data, that can contribute to the safety 
of future patients. 
In conclusion, patients will not directly benefit from the participation in this study but no 
additional risk related to the study participation is to be recognized.

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6.
STUDY OBJECTIVES
6.1
Primary Objective
The primary objective of the study is to evaluate the clinical safety profile of JTIN within the 
scope of its intended purpose, when used according to the manufacturer IFU on a 
representative population of subjects and users.
To fulfill this objective, one safety endpoint will be evaluated:
Percentage (%) of procedures with at least one serious/not serious adverse event 
certainly or possibly related to JTIN up to 1 year follow-up.
The primary endpoint is used to calculate the sample size of the study.
6.2
Secondary Objectives
The secondary objective of the study is to evaluate the clinical safety and performance of JTIN 
by the three following endpoints, when the MD is used within the scope and according to the 
manufacturer IFU:
Implant survival rate: percentage of not exchanged nails up to 1 year follow-up (safety);
Bone union achievement (performance);
Post-treatment fracture-free survival up to 1 year follow-up (performance)
These variables will be visually compared with data available on other devices on the market 
(state-of-the-art).
The sample size was calculated also to provide a significant sample for the evaluation of the 
following main performance endpoint: bone union achievement.
6.3
Exploratory Objectives
The Gillette Functional Assessment Questionnaire will be collected, according to hospital 
standard care, before the surgery Visit 0 (screening) and then at bone consolidation 
assessment (Visit 4) and at 1 year follow up (Visit 6), to evaluate the changes after treatment.
The questionnaire is performed by the investigator the first time (i.e. before the surgery) 
observing the patient (in presence or eventually via telemedicine), and for the follow-up it can 
be performed by the investigator by telephone or by email with the parent (or legal 
representative).
The Gillette Functional Assessment Questionnaire is not specific developed for OI patients 
but it is used in the hospital because no other score is currently available specifically for OI 
patients. The hospital is aware that other factors for OI patient can interfere with the score.

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7.
STUDY DESIGN
7.1
Research Type
This is a Post Market Clinical Follow-up (PMCF) study which is prospective and retrospective,
observational, single-center, not controlled.
No requirements regarding the treatment of patients will be imposed on the Site or Principal 
Investigator and the Sponsor will not in any manner influence the treatment decisions of 
Principal Investigator (i.e. non-interventional). The enrollment of patients and their treatment, 
including diagnostics and monitoring, will be guided solely by the principles of normal medical 
will ensure that the Device is used in accordance with normal medical practice and the 
instructions for use. The subjects will not undergo additional visit nor non-invasive, invasive or 
burdensome procedures additional to those performed under the normal clinical practice.
7.2
Subjects and Sites Numbers
This study will be conducted only on patients with a regular indication for JTIN as per IFU (no 
off-label use will be included): the nail is indicated for fractures, osteotomies, malunions and 
non-unions in femur and tibia in pediatric patients suffering from osteogenesis imperfecta. The 
JTIN is intended to be used in pediatric patients, older than 18 months.
This study includes only one site (monocentric) located in Paris, France. The site was chosen 
for this study due to the number of subject devices already implanted, and the wideness of the 
indications covered by the surgeries. The site was also positively evaluated by sponsor for the 
appropriate qualification and competency of the investigator and of the staff, and availability 
of facilities and equipment.
The enrollment objective for this study is of 20 evaluable cases (i.e. procedures, see
defined as one implanted JTIN nail in one treated bone. Each case can be evaluated and 
sessments 
if this happens before 
paragraph).
Therefore, a single patient at the clinical site can contribute for more than one case e.g.: a 
patient can have several JTIN each implanted in a different bone, or can have more JTIN 
implanted in the same bone but at different times.
7.3
Study duration
The study duration at the site is planned for 1,5 years (18 months), that includes the enrollment 
period of 6 months plus 1 year of data collection up to last patient last visit.
The study duration for each subject implant is approximately 1 year from the date of surgery, 
according to the visit schedule. Since the subjects will follow standard clinical care of the site

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and due to the observational character of the study, the study duration for each subject can 
be slightly different according to the standard of care.
7.4
Measures to Minimize or Avoid Bias
7.4.1
Blinding and Randomization
The present observational study is an un-controlled, single arm and open-label study 
therefore, no pre-defined subgroups are planned for the enrolled patients and no stratification, 
nor randomization, nor blinding procedures will be used. 
7.4.2
Subject Identifier
Each time a patient is planned to be treated with JTIN (or has been treated with JTIN after the 
1st of January 2022, i.e. retrospectively), he/she is considered potentially eligible for the study
and will be screened by the clinical site team to check if they satisfy all inclusion and exclusion 
criteria. Only if they satisfy the criteria, they will be informed about the study and asked if they 
want to participate.
-opposition to the participation to the study and data collection 
of the single specific implantation of JTIN will be duly documented in medical records. After
non-opposition documentation the site staff will create a record in the eCRF that generates a
consecutive identification number (ID), related to the procedure. The ID will be registered in 
the patient log. If the same patient agrees to participate for another JTIN procedure: another 
ID will be created and a reference to the first ID is made in the dedicated field in the eCRF and 
in the patient log.
7.5
End of Study (EOS)
The sponsor has the right to close this observational study at any time. 
The study will be terminated prematurely in the following cases:
-
If the enrolment rate and data collection are significantly delayed;
-
If the sponsor will be informed that the activities related to the study are conducted in 
conflict with the present protocol;
-
Any other reason for the sponsor to deem that the prosecution of the study will harm 
r rights.

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8.
SELECTION AND WITHDRAWAL OF SUBJECTS
8.1
Subject Inclusion Criteria
A patient will be included in the study if:
is in pediatric age (> 18 month and < 18 years) at the time of surgery;
is skeletally immature;
has a diagnosis for OI;
has a regular indication for surgical intervention with JTIN to treat femoral and/or 
tibial fractures, osteotomies, malunions and non-unions; 
participation.
8.2
Subject Exclusion Criteria
A patient will not be included in the study who:
instruction for use;
execution or due to which the patient should not participate for safety reasons;
requires the application of, or has already in-situ the application of concomitant 
devices that cannot be safely removed (except for permitted concomitant devices 
paragraph);
is participating in other clinical trials or has taken part in any clinical study in the last 3 
months with exception of analytical trials on genetics study related to OI (i.e. studies 
that do not include an investigational treatment for the patient such as new drugs or 
other medical devices);
8.3
Subject Withdrawal
Premature discontinuation from the study will occur when an enrolled patient (namely a patient 
who 
) will not undergo the final follow-up visit. 
At any time patients may prematurely discontinue from this study for any reason, without 
explanation and without losing the right to future medical care. The participation of the patient 
may, at any moment, be terminated by the Investigator as well, if considered appropriate (i.e. 
l interest). 
patients. Possible reasons for withdrawal of a patient from the study are:
-
lack of adequate therapeutic response resulting in an unacceptable risk;
-
major protocol violation;
-
an inclusion or exclusion criteria that becomes invalid; 
-
serious or intolerable AE preventing the patient from continuing the study;

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-
refusal of the patient to continue the treatment and/or protocol procedures;
-
decision by the Investigator if it would not be in the best interest of the patient to 
continue the study;
-
lost to follow-up;
-
death of the patient.
It is understood by all concerned that an excessive rate of withdrawals can render the study 
not interpretable, therefore, withdrawals of patients should be carefully assessed. However, 
if a patient decides to withdraw for any reason, all efforts will be made to complete and 
n end-of-
study visit page that will be available in the electronic Case Report Form (eCRF).
Any subject withdrawal, including lost to follow-up, must be traced by the investigator in the 
patient medical file and in the eCRF, including the possible reasons.
Until such time that the enrolment period is officially closed by the Sponsor, any withdrawn 
patients may be replaced by recruitment in accordance with the aforementioned protocol to 
reach the planned number of evaluable cases. The screening number assigned to the 
withdrawn patient will not be reassigned to another patient.

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9.
TREATMENT OF SUBJECTS
9.1
Study Investigational Product
The JTIN is indicated for fractures, osteotomies/deformities treatment, malunions and non-
unions in femur and tibia in pediatric patients (older than 18 months) suffering from 
osteogenesis imperfecta. The nail is designed for self-extension, adjusting the length of the 
device, in order to follow the patient growth as it occurs.
The nail includes the telescopic rod, which consists of two parts (male and female) and bone 
anchors, which could be either a cap or an epiphyseal screw suitable to the anatomical 
application or a pin for distal tibial anchorage.
The nail is available in five diameters, identified by the outer diameter of the female part of the 
rod, 3.5mm, 4.0mm, 4.5mm, 5.0mm and 6.0mm. Each diameter model is available in five 
lengths, from 100mm up to 350mm.
Application and removal of JTIN can be performed with Orthofix general orthopedic 
instrumentation.
The implants are made from AISI316LVM stainless steel, conforming to ASTM F138 and ISO-
5832.
Please refer to Appendix 1 for the implantable investigational device items catalog number.
Classification and Regulatory status
The JTIN is a CE marked device under European Union MDD 93/42, Annex IX, Classification 
criteria, as amended by 2007/47/EC)
The JTIN system consists of components classified as IIb, IIa, Ir and Is.
Manufacturer of the Investigational Device
Orthofix Srl
Via delle Nazioni 9 - 37012 Bussolengo (VR) Italy
Tel. 0039 (0) 45 6719000 - Fax 0039 (0) 45 6719380
Instruction for Use (IFU) and Operative Technique (OT)
Being JTIN a market device, the summary of the necessary training and experience needed 
to use the investigational device is described in the Manufacturer IFU, constantly published 
and updated by the manufacturer.
The description of the specific medical and surgical procedures involved in the use of the 
investigational device are described in the OT published and updated by the Manufacturer.
Current IFU and OT will be attached to the study documentation, and can also be found at the 
following link:
https://ifu.orthofix.it/home/index
Principle of operation of the device 
Telescopic intramedullary nails are often used to stabilize fractures, or multiple level 
osteotomies, whilst permitting continued longitudinal growth.
Based on the intramedullary nailing principle, a nail is inserted into the intramedullary 
channel of the femur and tibia. Thus, the nail provides a solid connection between bone 
segments while the bone anchors lock the nail to the bone.
Novel features
BONE AXIAL ALIGNMENT PRESERVATION

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The connection of female part of the rod and drill bit by means of a thread allows the 
surgeon to drive the nail into the intramedullary channel of the femur, through all the 
osteotomy sites, without loosening the bone position or without introducing additional 
hardware into the canal made by drilling.
The drill makes the path for the insertion on the rod which will immediately fill the gap 
with the female part. Competitor technique needs sequential insertion of male and 
female parts, this is not optimal because, even if the female part is guided by the male 
one, a bone dis-alignment leads to a difficult path to follow for the female part.
RETROGRADE FEMUR APPROACH
The JTIN is intended to be applied into intramedullary channel of the femur in a 
retrograde way.  This technique is newly used in OI and allows an easier bone 
alignment and deformity correction. Retrograde approach gives access to both the 
anchor points of the nail allowing for a better fixation and precise positioning into the 
knee (whereas is not possible with the current nails on the market).
SELF LOCKING CAP
The cap is used as bone anchorage, afterwards it must be connected to the rod in 
order to work properly. In a similar device as Bailey-Dubow nail the T-piece is 
connected by plastic deformation of the connection by means of pliers; the JTIN has a 
self-locking feature that enables the thread to gain stability without further 
manipulations. 
RETENTION ON DRIVER
The bone anchors, both the cap and the male part, have a threaded connection for 
instrument engaging. This allows the screwdriver to firmly grab the implant helping in 
manipulation and positioning.
Configurations or variants
JTIN includes a number of stainless steel rods, characterized by:
Diameter (of the female part of the rod)
Length (of the female part of the rod)
JTIN includes also stainless steel bone anchors to connect the rod to the bone. The bone 
anchor could be either a cap or an epiphyseal screw or epiphyseal pin, depending on the 
anatomical application.
Such bone anchors are provided together with the rod ready to be assembled.
Key functional elements
Implantable devices
The JTIN includes three different parts, intended to be assembled together to shape the 
device.
Figure 1 - JTIN assembled device
The parts of the JTIN device are:
Male part, a solid shaft with a built-in bone anchor for bone connection; the bone 
anchor has the same design of the cap.

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Female part, a hollow shaft designed to host the male part.
Bone anchors, that could be either one of the following items depending on the 
application:
o
Cap, a self-locking screw to be connected in a stable way with the female part 
of the rod at the opposite extremity respect the one the male part is inserted
o
Epiphyseal pin, a threaded pin to be inserted into the distal extremity hole in
order to hold the female part of the rod in position
Figure 2 - JTIN device exploded view
Figure 3 - JTIN assembled device with epiphyseal pin option
The male and female parts are intended to be coupled in order to build the telescopic rod. 
Male and female are free to move both axially and rotationally; this allow the nail to extend 
axially as the patient growth occurs and rotate for screw the built-in anchor of the male part 
into the bone.
9.1.1
Packaging and Labelling
This is a post-market and observational study: the investigational medical device labels is 
provided to the clinical site trough the approved and controlled commercial channels, 
therefore packaged and labelled according to marketed CE marked devices. 
9.1.2
Investigational Products Accountability and Storage
JTIN is provided to the clinical site trough the approved and controlled commercial channels 
and is part of clinical sites normal equipment repertoire. For this reason a dedicated 
investigational products accountability is not required. and the storage will be in charge of 
the site pharmacy as per manufacturer IFU. 

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9.2
Concomitant Treatments and Rescue Medications
9.2.1
Permitted Concomitant Treatments (Medications and Therapies)
K-wires, bone graft and any other concomitant devices, i.e. bone screws, that were applied 
to fix any bone fragments but that were not considered critical for the maintenance of treated 
bone alignment, are permitted during the study.
Examples of not permitted devices on the same JTIN-treated bone: plates providing fixation; 
external fixators; other intramedullary nails or elastic nails.
It is understood that any necessary medical devices applied on any other bones than the 
one treated by JTIN are permitted.
9.2.2
Contraindications according to Manufacturer IFU
The JTIN system must not be used if a surgical candidate exhibits or is predisposed to any 
of the following contraindications:
Active or suspected latent infections in or near the surgical area
Compromised bone stock, potentially leading to inadequate or unstable fixation of the 
device
Suspected or documented metal sensitivity reactions
Sepsis
Mental or physiological conditions, who are unwilling or incapable of following 
postoperative care instructions as it could result in a treatment failure in the intended 
population

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10.
STUDY PROCEDURES
10.1 Description of Procedures
Throughout the pre-study meetings, it was assessed and confirmed that the clinical data 
collected for the study purpose are part of the standard clinical practice for the participating 
investigational site. As this is an observational study, there are no change or influence on the 
normal clinical practice of the investigator and patients, and no interference with the local 
hospital standard of care guidelines and/or the internal therapeutic protocols set and 
established at the investigational site.
For the purpose of the study, the investigators will screen both:
patients that have undergone JTIN implantation surgery from the 1st of January 2022
patients that will receive JTIN implantation surgery (prospectively enrolled);
The investigators shall collect clinical data from the medical record of the subjects, concerning 
the screening criteria, the surgery (MD application) and 5 following visits: hospital discharge, 
plaster or immobilization removal, bone consolidation assessment and two follow-up visits.
Data from 
observation are gathered according to the site practice, therefore timelines 
and visit frequency presented in this protocol are estimated as average of the site normal 
clinical practice, actual visit timing for each patient will be performed according to investigators 
and hospital staff evaluation. The subjects will not undergo additional visit nor non-invasive, 
invasive or burdensome procedures additional to those performed under the normal clinical 
practice.
will be systematically collected by the investigator in the eCRF provided by 
Sponsor.   
10.2 Visits Description
10.2.1 Visit 0 - Screening
During the screening visit the investigator will evaluate the eligibility of the patients, checking 
all inclusion and exclusion criteria. Those patients who do not meet any of the criteria must 
not be enrolled and are considered as screening failures.
Only to patients who meet all inclusion and exclusion criteria the investigator will ask if he/she 
is willing to participate to the study and provide the Information sheet to the patient (and to the 
legal representative/guardian if applicable). Together with providing the Information sheet, the 
investigator (or an authorized designee) must also orally inform the patient (and the legal 
representative/guardian if applicable) about the objectives, procedures and duration of the 
study as well as the foreseeable risks and potential benefits deriving from participation in the 
same.
For each procedure for which the patient 
to participate in for the study, a 
unique enrolment number will be assigned, which becomes the procedure identification (ID) 
number as reported in the eCRF and will be registered in the patient log in the ISF. If the same 
patient agrees to participate for another JTIN procedure: another ID will be created and a 
reference to the first ID is made in the dedicated field in the eCRF and in the patient log.
Only for the enrolled patient, the Investigator will collect the demographic data and the medical 
history of the patient including information concerning the limb to be treated with JTIN
(baseline) such as the radiographic images, clinical examination (including WBP expressed 
by qualitative means and ROM as applicable) and the Gillette Functional Assessment 
questionnaire, according to hospital standard care.

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10.2.2 Visit 1 - Surgery (Day 0)
The investigator will collect information regarding the applied JTIN and the surgical 
intervention itself, including the intraoperative application time of fluoroscopy, previous device 
removal (if applicable) and eventual blood transfusion. The investigator will also collect X-
ray/fluoroscopy images, to assess the treatment outcome, and the medication prescribed after 
the surgery. From this visit and for the rest of the visits, the Investigator will collect information 
about adverse events (AEs) and medical device deficiency (MDD).
10.2.3 Visit 2 - Discharge (1 week ± 2 days)
The investigator will collect information regarding changes in the concomitant medication, AEs 
and MDDs, if any.
10.2.4 Visit 3 - Plaster or Immobilizer Removal (2 months ± 2 weeks)
The investigator will collect information regarding changes in the concomitant medication, AEs 
and MDDs, if any. The investigator will also collect x-ray images of the treated limb, clinical 
examination , and also the weight-bearing protocol assigned to the patient. The bone 
consolidation will be assessed by surgeon experience and evaluating corticalization of at least 
three sides of the callus on the radiographs. The WBP for this visit and the following ones will 
be expressed by qualitative means (e.g. non-weight bearing / partial weight bearing / full 
weight bearing).
10.2.5 Visit 4 - Bone Consolidation Assessment (5 months ± 2 months)
The investigator will collect information regarding changes in the concomitant medication, AEs 
and MDDs, if any. The investigator will also collect x-ray images of the treated limb, clinical 
examination will be performed, measure the Knee, Hip, Ankle ROM (as applicable) and also 
the weight-bearing protocol assigned to the patient. The bone consolidation will be assessed 
by surgeon experience and evaluating corticalization of at least three sides of the callus on 
the radiographs. 
10.2.6 Visit 5 - 2nd Follow-up Visit (9 months ± 1 month) 
The investigator will collect information regarding changes in the concomitant medication, AEs 
and MDDs, if any. The investigator will also perform clinical examination, and also the weight-
bearing protocol assigned to the patient.
10.2.7 Visit 6 - 3rd Follow-up Visit (1 year ± 1 month) 
The investigator will collect information regarding changes in the concomitant medication, AEs 
and MDDs, if any. The investigator will also collect x-ray images of the treated limb, clinical 
examination, measure the Knee, Hip, Ankle ROM (as applicable) and also the weight-bearing 
protocol assigned to the patient. The bone consolidation will be assessed by surgeon 
experience and evaluating corticalization of at least three sides of the callus on the 
radiographs. The Gillette Functional Assessment questionnaire is collected and can 
performed by the investigator in presence or also by telephone or by mail with the parent (or 
legal representative) in a different day from the visit, according to hospital standard care.

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11.
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS
11.1 Adverse Events
11.1.1
Definition of Adverse Event (AE)
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users, or other persons, whether or not related to the investigational 
medical device and whether anticipated or unanticipated.
Conditions or diseases diagnosed before subject inclusion in the study that are chronic but 
stable should not be recorded on AE pages of the CRF but they are a part of the Medical 
History. Chronic diseases which are diagnosed during subject participation in the study shall 
be recorded as AE/SAE.
11.1.2
Definition of Serious Adverse Event (SAE)
In accordance with ISO 14155:2020, a Serious Adverse Event (SAE) is an adverse event that 
led to any of the following:
a) death,
b) serious deterioration in the health of the subject, that either resulted in users, or
other persons as defined by one or more of the following:
a life-threatening illness or injury, or
a permanent impairment of a body structure or a body function including chronic 
diseases, or
in-patient or prolonged hospitalization, or
medical or surgical intervention to prevent life-threatening illness or injury, or 
permanent impairment to a body structure or a body function,
c) led to fetal distress, fetal death or, a congenital abnormality, or birth defect including physical 
or mental impairment.
Planned hospitalization for a pre-existing condition, or a procedure required by the protocol 
without serious deterioration in health, is not considered a serious adverse event. If a subject 
is hospitalized to undergo a medical or surgical procedure as a result of an AE, the event 
responsible for the procedure, not the procedure itself, should be recorded as the event. 
Hospitalizations for the following reasons will not be recorded as SAEs:
Hospitalization or prolonged hospitalization for diagnostic or elective surgical 
procedures for preexisting conditions if not associated with the new occurrence of 
AE/SAE
Hospitalization or prolonged hospitalization required to allow outcome measurement 
for the study if not associated with the new occurrence of AE/SAE
Hospitalization or prolonged hospitalization for scheduled therapy of the target disease 
of the study if not associated with the new occurrence of AE/SAE.

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11.1.3
Definition of Adverse Device Effect (ADE)
An adverse device effects describes an adverse event related to the use of an investigational 
medical device.
This includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational 
medical device.
This includes any event resulting from use error or from intentional misuse of the 
investigational medical device.
11.1.4
Definition of Serious Adverse Device Effect (SADE)
SADE are any adverse device effect that has resulted in any of the  characteristics of a serious 
adverse event (see above).
USADE are serious adverse device effect which by its nature, incidence, severity or outcome 
has not been identified in the current risk assessment.
Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, 
severity or outcome has been identified in the risk assessment.
11.1.5
Possible Adverse Device Effect according to Manufacturer IFU 
List of possible Adverse Device Effect expected from Manufacturer IFU (ASADE):
Non-union, delayed union or malunion
Superficial infection
Deep infection
Bending, breakage or migration of the device
Bone fracture during or after treatment
Damage to bone vascularization (e.g. proximal femoral epiphysis)
Damage to surrounding tissues due to surgical trauma
Pain, discomfort or abnormal sensations due to the presence of the device 
Possible lesion to the growth plates
Residual deformities, persistence or recurrence of the initial condition subject to 
treatment
Wound healing complications
Stiffness at surgery site
Problems related to telescopic functioning
Events caused by intrinsic risks associated with anesthesia and surgery
11.1.6
Possible ADE incidence, mitigation, and treatment 
The incidence of the possible ADE identified by the Manufacturer is not available for 
investigational device (JTIN) because the present study is the first systematic clinical data 
collection on the device. The following table provides a pooled complication rates from 
published literature.

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Surgical revision
22.22% - 50% [Rosenberg, 2018]; [Sarikaya, 2019]; [Scollan, 2017]
Bone deformity
4.3% - 30% [Lee K, 2015]; [Scollan, 2017]; [Shin, 2018]
Repeat fractures
11.11% - 37.29% [Popkov, 2020]; [Rosenberg, 2018]; [Sarikaya, 
2019]; [Scollan, 2017]; [Shin, 2018]
Hardware 
displacement/ 
breakage/bending
32% - 33% [Lee K, 2015]; [Scollan, 2017]; [Shin, 2018]
Non-union/delayed 
union
8.47% - 36% [Lee K, 2015]; [Scollan, 2017]; [Shin, 2018]
Osteomyelitis
(infection)
3.85% [Rosenberg, 2018]
Limited/absent 
telescoping
11.11% - 40% [Rosenberg, 2018]; [Sarikaya, 2019]
Repeat fractures is the most commonly reported complication with the use of intramedullary 
nails, although that might be due to the inherent bone fragility associated with OI. 
Among the hardware-related complications, rod migration was the most reported one that 
might lead to an increased rate of surgical revision.
The Manufacturer has developed the novel feature the JTIN system to mitigate these two more 
commonly reported complications. JTIN system features and the retrograde technique, newly 
used in OI, allow to obtain stable bone fixation and an easier bone alignment and correct 
deformities (see chapter 9.1 Study Investigational Product
All AE/ADE and any device deficiency will be treated by the clinical center according to the 
clinical standard practice of the hospital, since this is an observational study. All events will be 
recorded and reported in the case report form as appropriate, see following paragraphs.
11.1.7
Relationship between an AE/SAE and the use of the medical device
All AE/SAE will be judged by both the reporting Investigator and the sponsor as having a 
reasonable causal relationship to the investigational medical device. The relationship between 
the AE/SAE and the investigational medical device is considered 
-
Certain when the AE/SAE occurs in a plausible time relation to the application of the 
device and cannot be explained by a concurrent disease or other devices, drugs or 
chemicals. The response to withdrawal of the device (de-challenge) should be clinically 

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plausible. The event must be definitive using a satisfactory re-challenge procedure if 
necessary;
-
Possible when the AE/SAE occurs with a reasonable time relation to the application of 
the device, but it could also be explained by a concurrent disease or other devices, drugs 
or chemicals. Information on device withdrawal (de-challenge) may be lacking or unclear;
The AE/SAE is Not Related to the use of the investigational device in case of:
-
existence of a clear alternative explanation, and/or
-
unreasonable temporal relationship between application and/or
-
non plausibility.
11.1.8
Medical Device Deficiency (MDD)
quality, durability, reliability, usability, safety or performance, such as malfunction, misuse or 
related to the device and ancillary tools used for the clinical investigation (for the present study 
it is the JTIN and ancillary tools used for implantation and extraction, see Appendix 1 for 
ancillary tools) and, when applicable, related to the comparative devices as well (for this study
the comparative devices is not applicable).
Device deficiencies include malfunctions, use errors, and inadequacy in the information 
supplied by the manufacturer including labelling.
11.1.9
Incident
Incident means any malfunction or deterioration in the characteristics or performance of a 
device made available on the market and related ancillary tools used for implantation and 
extraction, including use-error due to ergonomic features, as well as any inadequacy in the 
information supplied by the manufacturer and any undesirable side-effect; Incidents will be 
followed according to routine materiovigilance requirements.
11.1.10 Procedures for Reporting and Recording AE, SAE and Medical Device Deficiencies
The investigator will follow the standard clinical practice to record data in the medical file.
He/she will follow the national applicable vigilance procedures for any applicable case of AE
or incident, and the manufacturer instruction to report any MDDs or AE as appropriate.
In addition to the above-mentioned requirements, the investigator will also record the AEs and 
MDDs in the eCRF. For both cases the investigator, when reporting the event in the eCRF will 
describe:  
-
date of the event;
-
treatment;
-
resolution;

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-
whether or not it is Serious and 
-
whether or not it is related to the use of the investigational device and the related 
procedure
When applicable, the investigator should also provide any available information and diagnostic 
measurements (laboratory test, X-ray etc) related to the AE and store it in the eCRF.
11.1.11
Notification deadlines
Notification to Sponsor
Serious MDDs and SAEs related to the investigational medical device and related procedure
must be notified by the Investigator to the Sponsor through the appropriate form (Safety 
Reporting Form PO218-02) provided with the study documentation immediately, or within 2 
calendar days from awareness, at the latest. This timeline applies only to prospective 
investigational data.
Please email the completed Safety Reporting Form Device deficiency and Compliant to 
Orthofix Srl at the following:
Safety Contact Information
safetyclinicalstudiesintl@orthofix.com
complaintintl@orthofix.com
Notification to Authorities
All SAEs related to an investigational procedure leading to death or imminent threat to death, 
a serious injury or disease, requiring a rapid corrective action must be notified by the sponsor 
to Competent Authority immediately or within 2 days at the latest.
Other SAEs must be notified by the sponsor to Competent Authority immediately or within 7 
days at the latest.
The same guidance applies to complementary information related to these events.
In addition, as this is a PMCF observational study regarding a CE-marked device, the sponsor 
will comply with Articles 87 to 90 of MDR and detailed in MDCG 2023-3 (published in February 
2023)
According to mentioned articles and guidelines, the sponsor will report to the competent 
authority all incidents that will occur during the use of the medical device covered by this study 
by specific reporting. For serious incidents with the most urgency, the reporting will be through 
Manufacturer Incident Report MIR 7.2.1 and sent to the competent authority with the most 
urgency and in any case no later than 10 days as well as to the local EC. For all other incidents, 
this timeline is within 30 days.

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12.
STATISTICS
12.1 Statistical and Analytical Plans
Clinical data collected throughout the study will be analyzed by descriptive statistics to assess 
the study objectives. Descriptive statistics will be provided in summary tables according to the 
type of variable summarized:
-
Quantitative variables will be summarized by using n (sample size), arithmetic mean, 
standard deviation (SD), median, minimum and maximum.
-
Categorical variables will be summarized by using frequency distribution and 
percentages.
The design of the proposed study does not involve randomization, so no pre-defined 
subgroups of subjects are planned to be enrolled. 
For time-to-event variables, cumulative freedom from event will be evaluated using Kaplan-
Meier (KM)
method. The degree of uncertainty will be expressed with 95% confidence limits (calculated 
per the method proposed by Greenwood). KM graphs will be presented along with the number 
of case-at-risk at exact time points.
Unless otherwise specified, the significance level used for other statistical testing (for 
descriptive purposes) will be 0.05 and two-sided tests will be used. 
The Statistical Analysis Plan (SAP) could be issued before database lock with more technical 
and detailed elaboration of the principal features of statistical analyses. Any deviations from 
the original statistical plan (including unplanned analyses) will be documented in the Clinical 
Study Report.
12.1.1
Population(s) of analysis
The following populations will be defined:
-
The Full Analysis Set (FAS) population will consist of all enrolled patients treated by 
the means of JTIN application and who 
. The FAS 
population will be used for all the analyses of the study that are presented at subject 
level.
-
The Full Analysis Implant Set (FAIS) population will consist of all JTIN applications 
performed on subjects belonging to the FAS population. The FAIS population will be 
used for all the analyses of the study that are presented at implant level.
12.1.2
Efficacy, Safety and Other Variables
12.1.2.1 Efficacy Variables
Efficacy variables will include:
1.
Bone union achievement;
2.
Post-treatment fracture free survival.

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12.1.2.2 Safety Variables
Safety variables will include:
1.
Any complications;
2.
Re-operation/Revision;
3.
Implant survival;
4.
Any expected/unexpected AE (see Section 11.1.5 for details).
12.1.2.3
Other Variables
All variables reported in the Table above (Section 4.1) will be included, as per scheduling 
assessment.
12.2 Statistical Evaluation
12.2.1
Evaluation of Safety
To evaluate the primary safety objective of the analysis, the number of all AEs, SAEs and 
MDDs and the number and the percentage of implants with subsequent AEs, SAEs and MDDs 
will be summarized (primary endpoint), together with the information about relationship 
(certainly or possibly related) to JTIN.
In addition, a similar analysis will be performed at subject level (number and percentage of 
subjects with at least one implant with subsequent adverse events).
Furthermore, as secondary safety endpoint, the implant survival rate will be evaluated and 
reported as percentage of implants with no exchanged nails up to 1 year follow-up.
12.2.2
Evaluation of Efficacy
The first efficacy endpoint (Bone union achievement) will be analyzed reporting the number 
and the proportion of procedures with bone union achieved (Success) together with the 
relative 95% confidence interval.
The second efficacy endpoint (Post-treatment fracture-free survival) will be analyzed reporting 
the number and the proportion of procedures with fracture(s) occurred in the treated bone up 
to 1 year follow-up together with the relative 95% confidence interval.
The cumulative freedom from fracture will be also evaluated using Kaplan-Meier (KM) method, 
the degree of uncertainty will be expressed with 95% confidence limits (calculated per the 
method proposed by Greenwood) and a KM graph will be presented along with the number of 
case-at-risk at exact time points.
12.2.3
Exploratory Analyses
Change in Gillette Functional Assessment Questionnaire from Screening to bone 
consolidation assessment visit and to 1 year follow up will be analyzed by means of 

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descriptive statistics as a continuous variable. Pre-post comparisons will be performed by 
means of paired t-test.
12.3 Determination of the Sample Size
Due to the observational nature of the study, no formal sample size calculation has been done, 
but a revision of the literature on the complication rates (intended as at least one serious/not 
serious adverse event certainly or possibly related to the procedure up to 1 year follow-up)  
has been made. The scientific literature reports that the percentage of procedures which 
develop at least one serious/not serious adverse event certainly or possibly related to the 
procedure itself is between 9% and 60%, with a mean of 31%. Assuming a complication rate 
aligned or better than the mean observed in literature (31%), a sample size of 15 procedures 
will be sufficient to estimate the adverse event rate with the upper limit of the 95% confidence 
interval equal or lower than the worst complication rate seen in literature (i.e. 60%).
Starting from this sample size, to also assume that the success rate (intended as proportion 
of procedures that result in a bone union achieved) is aligned or better than the mean observed 
in literature (80%), 20 procedures will be needed.
Considering a drop-out or a non-evaluable rate of 20% of the procedures, a total of 
approximately 25 procedures should be made. Each subject could have from 1 to 4 
procedures. Assuming the worst scenario of no more than 1 procedure for subjects, a 
maximum of 25 subjects needs to be enrolled. Anyway, the enrolment will stop when the total 
number of the procedures is reached. 
12.4 Interim Analysis
No interim analysis is planned.
12.5 Dictionaries
Medical/Surgical history, concomitant diseases and AEs will be coded using Medical 
Dictionary for regulatory activities (MedDRA) dictionary and reported in separate tabulations. 
Frequency distributions and percentages will be summarized by System Organ Class (SOC) 
and Preferred Term (PT).
Prior and/or concomitant medications will be coded using World Health Organization Drug 
Dictionary and reported in separate tabulations. Frequency distributions and percentages will 
be summarized by Anatomical Main Group (1st level of the Anatomical Therapeutic Chemical 
(ATC) classification), Chemical Subgroup (4th level of the ATC classification) and Preferred 
Name.

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13.
ETHICS AND REGULATORY REQUIREMENTS
13.1 Approval
As a PMCF observational study conducted on a CE-marked medical device used according 
to its intended use with no additional procedure, t
2017/745 nor French Jardé law on Research that implies human beings.
As Data Controller, the sponsor commits to comply with GDPR- 679/2016 and Title II Chapter 
3 Section 3 of French Data Protection law of January 6th, 1978 regarding data processing.
According to Article 73 of French Data Protection law, considering that data processing related 
to this study complies with CNIL
reference methodology MR-004, for which the Sponsor, as 
Data Controller, has previously registered a compliance commitment with the French data 
protection body, authorization from CNIL is not mandatory for data processing and study start. 
Sponsor has also submitted the study to APHP Research Ethical Committee.
13.2 Subject Information and Non-opposition
The screened patients, who has undergone JTIN implantation according to the standard-of-
care and comply to all inclusion and exclusion criteria, should not oppose to participate in this 
study. Prior to being enrolled into the study, each patient, according to the age range, and 
his/her parents/legal representative, will be informed by the Investigator or his/her designee
regarding the purpose of the study and the clinical data that will be collected. The Investigator 
will deliberate that, considering this is an observational study, there are no additional 
foreseeable risks and potential benefits resulting from study participation compared to normal 
clinical practice. 
Each patient/parents/legal representative will be informed by the Investigator that he/she is 
free to refuse to participate in the study and, if he/she chooses to participate, that he/she may 
withdraw from the study at any time without providing reasons. In addition, the 
patient/parents/legal representative will be informed that, in some necessary cases, the 
Investigator may prematurely terminate their participation providing an appropriate reason. 
The Investigator will provide the patient/parents/legal representative with her/his contact 
details in case they need further information after inclusion.
Each patient/parents/legal representative will be informed that his/her medical records will be 
Subject to review by the Sponsor representatives and may be subject to review from auditor
and regulatory authorities. 
The data collected during the treatment period, will be systematically entered by the 
investigator in eCRF.
The patients/parents/legal representative will be informed during their participation to the 
study about any new information eventually available about the medical device by the 
investigator.
concerned 

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13.3 Subject Confidentiality
All information and data concerning patients participating in this study will be considered 
confidential according to the requirements of EU GDPR regulations and national applicable 
regulations. The Information sheet shall describe the process of subject data protection in 
details. 
Each enrolled subject will be assigned to a unique study ID number for each procedure, which 
is pre-configured in the EDC and all data collected in EDC will be identified only by this ID 
number.  Records of the subject/study ID number relationship will be maintained only by the 
study center. 
The study ID number is to be recorded on all study documents to link them to
personal identifiers should not be recorded on any study document entered in EDC. In the 
blinded as applicable. 
Confidentiality of data will be observed by all parties involved at all times throughout the 
study.  All data shall be secured against unauthorized access.  The privacy of each subject 
and confidentiality of his/her information shall be preserved in reports and when publishing 
any data.

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14.
STUDY MANAGEMENT AND ADMINISTRATION
14.1 Supplies
After the required approval will be obtained before the site will be initiated, the sponsor, also 
through its appointed partners, will provide the site with the following supplies:
-
A paper and electronic copy of this protocol; 
-
Copies of the Information sheet to be provided to the enrolled Subjects;
-
Blank copies of the non-opposition form to be signed by the Investigator or his/her 
designee;
-
The Investigator Site File (ISF) containing all the study related documents;
-
An eCRF platform and the credential to enter the system to upload clinical data.
14.2 Monitoring
The sponsor planned to perform a 100% source data verification (SDV) on inclusion/exclusion 
the SDV will be performed by random spot check (20% of the total visits entered in the eCRF). 
Before each visit the monitors will contact the investigator/center to schedule the visit and will 
send a written confirmation and the related agenda.
In order to fulfill its responsibility of assuring the proper conduct of the study regarding 
adherence to the protocol and the completeness and accuracy of the data recorded on the 
case report forms, the sponsor planned to perform at least the following monitoring visits:
Site Initiation Visit (SIV), to be performed after EC/administrative approval;
4 monitoring visits throughout the life phase of the study;
A detailed description of the monitoring activities will be provided in a separate Monitoring 
Plan. In case of need the investigational site is subjected to additional monitoring visits. The 
Investigator and/or study staff is expected to be available for at least a portion of the 
monitoring visit to answer to questions and to provide any missing information.
14.3 Direct Access to Source Data/Documents
With all efforts to ensure that pa
-anonymity and confidentiality is respected, 
the Investigator will permit the clinical monitors to have direct access to all study records, 
including hospital records, all source documents and ISF.
14.4 Audit and Inspection
There may be a possibility that the Quality Assurance Department of the sponsor or the 
Regulatory Authorities may audit or inspect the site to verify compliance to protocol,
procedures and applicable regulations.
The investigator will permit to be audited/inspected by sponsor personnel and/or Regulatory 
Authorities during and/or after the study has been completed. 

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14.5 Adherence to Protocol
Protocol deviations will be reported to the sponsor who will assess their significance (Major 
and Minor) with regards to the impact on the rights, safety, and well-being of human subjects, 
and to the impact on quality and data integrity. All deviations will be reported and discussed 
in the study report.
In case of a protocol amendment, before the suggested modifications will be implemented, 
the sponsor will notify the new version of the protocol to the relevant IEC and authorities, 
specifying whether the modifications are substantial/not-substantial and, if applicable, will put 
the study on hold until the re-approval will be obtained, if applicable.
14.6 Data Handling and Retention
The sponsor and the investigator assume the responsibility to assure that the clinical data will 
be collected according to the CIP requirements (no additional data will be collected), local laws 
and obligations and the World Medical Association Declaration of Helsinki. The clinical data 
obtained as a result of this study is considered confidential between the site and the sponsor: 
disclosures to third part are prohibited or, if necessary for example to perform statistical 
analysis with contracted vendors, will be protected by non-disclosure agreements.
Before the Site Initiation Visit, the sponsor will provide an eCRF system (Castor) that is 
validated according to applicable laws and regulations, including 21 CFR Part 11, EU Annex 
11, General Data Protection Regulation (GDPR), HIPAA (US), ISO 9001 and ISO 27001. The 
Sponsor will provide training to the Investigators/CRA about the data entry procedures and 
queries solving. The clinical data entered in the eCRF must come from the source data, that 
is all information in original (or certified copies) reported in source documents (for example: 
The investigator assumes the responsibility to assure that the last data will be entered within 
1 month after the last patient last visit (including all queries resolution).  
The investigator will have to keep all study related documentation for the longest possible 
duration, but at least for 15 years after the completion or premature termination of the study. 
No data should be destroyed without agreement with the sponsor. The Sponsor will maintain 
all documentation pertaining to the study for the lifetime of the product.  
Sponsor and investigators shall take measures to prevent accidental or premature destruction 
of these documents and they may rely on a third part for documents retention by a non-
disclosure agreement to protect data confidentiality.

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14.7 Clinical Study Report
The clinical study report shall be completed by the sponsor, or a designed delegate by the 
means of a non-disclosure agreement, even if the study will be terminated prematurely, only 
after:
-
all queries concerning the eCRF will be closed;
-
the database will be locked;
-
the statistical report will be written and approved.
The sponsor will draft the clinical study report after the finalization of the statistical report. The 
clinical study report will be reviewed and approved by the investigator and, as soon as 
available, shall be provided to the relevant IEC and authorities (when applicable).
14.8 Insurance and Liability
No additional procedures for the patients nor for the investigational team members are 
planned for the present observational study with respect to the normal clinical practice, that 
actually comprises a retrospective and prospective data collection. The sponsor, therefore, is 
not requested to put in place an additional dedicated liability insurance covering this study.
14.9 Financial Disclosure
Assumed this is a sponsored study, after the relevant IEC and authority approval/authorization
the sponsor will put in place with the hospital administration of the site an agreement that will 
allow to pay the involved department for study execution. 
The information regarding Financial Disclosure of the Investigator will be collected and 
retained in the Trial Master File.
14.10
Publication
The sponsor and the investigator intend to compile a comprehensive publication of study 
results in a peer review journal, within 6 months from study completion or early termination, 
appropriately addressing contributions of co-authors.
Co-authors will be designated by the investigator (study staff at the hospital e.g. sub-
investigator) and by the sponsor from the staff involved in the design and conduction of the 
study. 

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The sponsor recognizes the right and interest of co-authors, to scientifically publish the results 
obtained from the study for non-commercial purposes, even if the effects ascribed to the 
investigational product fail to materialize. All article or scientific presentation from investigator 
and co-authors can be published only after the first publication of the results by the sponsor.
The sponsor, together with the investigator, reserve the right to publish and present the results 
of this study at scientific congresses, to submit these clinical trial data to national and 
international Regulatory Authorities.
At least 30 days before any publication or presentation of study results, co-authors agree in 
submitting a manuscript/abstract of the intended publication or presentation to the sponsor for 
review. The sponsor will provide its revision within 15 working days. Proposals for changes 
and modifications raised by sponsor will be taken into consideration by the participating 
Investigators if such proposals do not interfere with the scientific nature and content of the 
publication. 
The identity of the sponsor and the nature of his contribution to this study shall be disclosed 
in any publication or presentation.
The sponsor, according to current EU regulation (MDR 2017/45) and guidelines (ISO 14155) 
is responsible to register the study in a publicly accessible database. The current status and 
details of the study is publicly accessible on ClinicalTrials.gov at the registration nr. 
NCT05612139. 

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15.
REFERENCES
1.
Azzam KA, Rush ET, Burke BR, Nabower AM, Esposito PW. Mid-term Results of Femoral 
and Tibial Osteotomies and Fassier-Duval Nailing in Children with Osteogenesis 
Imperfecta. J Pediatr Orthop. 2018 Jul;38(6):331-336. doi: 
10.1097/BPO.0000000000000824. PMID: 27379783
2.
Birke O, Davies N, Latimer M, Little DG, Bellemore M. Experience with the Fassier-Duval 
telescopic rod: first 24 consecutive cases with a minimum of 1-year follow-up. J Pediatr 
Orthop. 2011 Jun;31(4):458-64. doi: 10.1097/BPO.0b013e31821bfb50. PMID: 21572286
3.
Landrum, M., Birch, C., & Richards, B. S. Challenges encountered using Fassier-Duval 
rods in osteogenesis imperfect. Current Orthopaedic Practice, 30(4), 2019, 318-322. 
https://doi.org/10.1097/BCO.0000000000000781
4.
Lee K, Park MS, Yoo WJ, Chung CY, Choi IH, Cho T-J. Proximal Migration of Femoral 
Telescopic Rod in Children With Osteogenesis Imperfecta Journal of Pediatric 
Orthopaedics 2015;35:178 84. https://doi.org/10.1097/BPO.0000000000000228
5.
Novacheck, Tom F.; Stout, Jean L.; Tervo, Raymond Reliability and Validity of the Gillette 
Functional Assessment Questionnaire as an Outcome Measure in Children with 
Walking Disabilities. Journal of Pediatric Orthopaedics 2000 PMID: 10641694
6.
. Treatment of 
tibial deformities with the Fassier Duval telescopic nail and minimally invasive 
percutaneous osteotomies in patients with osteogenesis imperfecta type III. Journal of 
Pediatric Orthopaedics B 2019;28:179 85. https://doi.org/10.1097/BPB.0000000000000536
7.
Popkov D, Dolganova T, Mingazov E, Dolganov D, Kobyzev A. Combined technique of 
titanium telescopic rods and external fixation in osteogenesis imperfecta patients: 
First 12 consecutive cases. Journal of Orthopaedics 2020;22:316 25. 
https://doi.org/10.1016/j.jor.2020.05.017
8.
Rosemberg DL, Goiano EO, Akkari M, Santili C. Effects of a telescopic intramedullary rod 
for treating patients with osteogenesis imperfecta of the femur. J Child Orthop 
2018;12:97 103. https://doi.org/10.1302/1863-2548.12.170009
9.
Sarikaya I, Seker A, Erdal OA, Gunay H, Inan M, Guler B. Using a corkscrew-tipped 
telescopic nail in the treatment of osteogenesis imperfecta: a biomechanical study and 
preliminary results of 17 consecutive cases. Journal of Pediatric Orthopaedics B 
2019;28:173 8. https://doi.org/10.1097/BPB.0000000000000537
10. Scollan JP, Jauregui JJ, Jacobsen CM, Abzug JM. The Outcomes of Nonelongating 
Intramedullary Fixation of the Lower Extremity for Pediatric Osteogenesis Imperfecta 

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Patients: A Meta-analysis. Journal of Pediatric Orthopaedics 2017;37:e313 6. 
https://doi.org/10.1097/BPO.0000000000000970
11. Shin CH, Lee DJ, Yoo WJ, Choi IH, Cho T-J. Dual Interlocking Telescopic Rod Provides 
Effective Tibial Stabilization in Children With Osteogenesis Imperfecta. Clin Orthop 
Relat Res 2018;476:2238 46. https://doi.org/10.1097/CORR.0000000000000429
12. Sterian AG, Ulici A. Revision Rates for Osteogenesis Imperfecta Patients Treated with 
Telescopic Nails. A follow-up Study After a 7-year Experience. J Med Life. 2020 Oct-
Dec;13(4):543-547. doi: 10.25122/jml-2020-0161. PMID: 33456604; PMCID: PMC7803301
13. Yong, B., S. De Wouters, and A. Howard, Complications of Elongating Intramedullary 
Rods in the Treatment of Lower Extremity Fractures for Osteogenesis Imperfecta: A 
Meta-Analysis of 594 Patients in 40 Years. J Pediatr Orthop, 2022. 42(3): p. e301-e308

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16.
APPENDICES
16.1 Appendix 1: Investigational Device items catalog number
Sterile version:
Non-sterile version
CATALOG NUMBER
DESCRIPTION 
99-67735100
JTIN TELESCOPIC NAIL L100MM D3.5MM STERILE
99-67735120
JTIN TELESCOPIC NAIL L120MM D3.5MM STERILE
99-67735130
JTIN TELESCOPIC NAIL L130MM D3.5MM STERILE
99-67735140
JTIN TELESCOPIC NAIL L140MM D3.5MM STERILE
99-67735150
JTIN TELESCOPIC NAIL L150MM D3.5MM STERILE
99-67740130
JTIN TELESCOPIC NAIL L130MM D4.0MM STERILE
99-67740155
JTIN TELESCOPIC NAIL L155MM D4.0MM STERILE
99-67740180
JTIN TELESCOPIC NAIL L180MM D4.0MM STERILE
99-67740205
JTIN TELESCOPIC NAIL L205MM D4.0MM STERILE
99-67740230
JTIN TELESCOPIC NAIL L230MM D4.0MM STERILE
99-67745160
JTIN TELESCOPIC NAIL L160MM D4.5MM STERILE
99-67745175
JTIN TELESCOPIC NAIL L175MM D4.5MM STERILE
99-67745190
JTIN TELESCOPIC NAIL L190MM D4.5MM STERILE
99-67745205
JTIN TELESCOPIC NAIL L205MM D4.5MM STERILE
99-67745230
JTIN TELESCOPIC NAIL L230MM D4.5MM STERILE
99-67750250
JTIN TELESCOPIC NAIL L250MM D5.0MM STERILE
99-67750275
JTIN TELESCOPIC NAIL L275MM D5.0MM STERILE
99-67750300
JTIN TELESCOPIC NAIL L300MM D5.0MM STERILE
99-67750325
JTIN TELESCOPIC NAIL L325MM D5.0MM STERILE
99-67750350
JTIN TELESCOPIC NAIL L350MM D5.0MM STERILE
99-67760250
JTIN TELESCOPIC NAIL L250MM D6.0MM STERILE
99-67760275
JTIN TELESCOPIC NAIL L275MM D6.0MM STERILE
99-67760300
JTIN TELESCOPIC NAIL L300MM D6.0MM STERILE
99-67760325
JTIN TELESCOPIC NAIL L325MM D6.0MM STERILE
99-67760350
JTIN TELESCOPIC NAIL L350MM D6.0MM STERILE
CATALOG NUMBER
DESCRIPTION 
67735100
JTIN TELESCOPIC NAIL L100MM D3.5MM
67735120
JTIN TELESCOPIC NAIL L120MM D3.5MM
67735130
JTIN TELESCOPIC NAIL L130MM D3.5MM
67735140
JTIN TELESCOPIC NAIL L140MM D3.5MM
67735150
JTIN TELESCOPIC NAIL L150MM D3.5MM
67740130
JTIN TELESCOPIC NAIL L130MM D4.0MM
67740155
JTIN TELESCOPIC NAIL L155MM D4.0MM
67740180
JTIN TELESCOPIC NAIL L180MM D4.0MM
67740205
JTIN TELESCOPIC NAIL L205MM D4.0MM
67740230
JTIN TELESCOPIC NAIL L230MM D4.0MM
67745160
JTIN TELESCOPIC NAIL L160MM D4.5MM
67745175
JTIN TELESCOPIC NAIL L175MM D4.5MM
67745190
JTIN TELESCOPIC NAIL L190MM D4.5MM
67745205
JTIN TELESCOPIC NAIL L205MM D4.5MM

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Ancillary Tools
67745230
JTIN TELESCOPIC NAIL L230MM D4.5MM
67750250
JTIN TELESCOPIC NAIL L250MM D5.0MM
67750275
JTIN TELESCOPIC NAIL L275MM D5.0MM
67750300
JTIN TELESCOPIC NAIL L300MM D5.0MM
67750325
JTIN TELESCOPIC NAIL L325MM D5.0MM
67750350
JTIN TELESCOPIC NAIL L350MM D5.0MM
67760250
JTIN TELESCOPIC NAIL L250MM D6.0MM
67760275
JTIN TELESCOPIC NAIL L275MM D6.0MM
67760300
JTIN TELESCOPIC NAIL L300MM D6.0MM
67760325
JTIN TELESCOPIC NAIL L325MM D6.0MM
67760350
JTIN TELESCOPIC NAIL L350MM D6.0MM

Study code: OCI_2201
Protocol date: 02/08/2024
Protocol version: 1.1
CONFIDENTIAL
Page 45 of 45
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PO 216-01: Orthofix CIP Template