Osteogenesis ImperfectaJTINNCT05612139
Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
An observational study of Osteogenesis Imperfecta, run by Orthofix s.r.l. at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- JTIN implantation surgery
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2024to 20 Feb 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients older than 18 months suffering from osteogenesis imperfecta.
Who may be able to join
- 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;
- patient and/or legal representative is duly informed and doesn't oppose to participation.
Who cannot join
- has a medical condition that is a contraindication according to the manufacturer's instruction for use;
- has any conditions that in the Investigator's opinion may 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 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);
- is likely to be lost to follow up, according to investigator's opinion.
Trial locations and contacts
1 site in 1 country.
France1 site
Necker-Enfants Malades Hospital
Paris, Île-de-France Region, 75015
About this study
Official title: 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
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. 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.
Read the detailed description
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 "Visits and Assessments Schedule"). 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.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- JTIN implantation surgery
- Keywords
- nailing, nail, Osteogenesis, pediatric, bone, rare disease, brittle, telescopic
- Medical subject headings
- Osteogenesis Imperfecta, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTIN implantation surgeryDevice
The JTIN is a self-extending intramedullary nail (telescopic rod) designed to provide 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. These two components slide from each other, allowing for extension of the JTIN as the bone structures remodel and patient growth occurs.
| Study group | Role | What they receive |
|---|---|---|
| JTIN treated patients | Pediatric patients, older than 18 months, suffering from osteogenesis imperfecta treated with JTIN telescopic nail Receives: Device: JTIN implantation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Procedures With at Least One Serious/Not Serious Adverse Event Certainly or Possibly Related to JTIN
The primary endpoint is measured to evaluate the clinical safety profile of JTIN within the scope of its intended purpose.
Measured: 1 year
Secondary outcomes (3)
Implant Survival Rate: Percentage of Not Exchanged Nails
This endpoint measures how many nails, in percentage, remains functional in the patient without requiring surgical replacement. Specifically, it represents the proportion of implanted nails that do not need to be exchanged during the follow-up period for any reason. A higher implant survival rate indicates better durability, safety for patients and clinical performance. This endpoint is measured to evaluate the clinical safety of JTIN.
Measured: 1 year
Percentage of Procedures With Bone Union Achievement
This endpoint is measured to evaluate the clinical performance of JTIN.
Measured: 1 year
Post-treatment Fracture-free Survival Rate
This endpoint is measured to evaluate the clinical performance of JTIN.
This endpoint is described with the percentage of patients that experienced a fracture of the JTIN-treated bone during the specified time frame.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start27 Aug 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zagorka Pejin, MD, Principal investigator, Necker-Enfants Malades Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612139
- Sponsor's protocol ID
- OCI_2201
- Acronym
- JTIN
- Status last verified
- Jan 2026
- First submitted
- 3 Nov 2022
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27379783Birke 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.
PubMed 21572286Novacheck TF, Stout JL, Tervo R. Reliability and validity of the Gillette Functional Assessment Questionnaire as an outcome measure in children with walking disabilities. J Pediatr Orthop. 2000 Jan-Feb;20(1):75-81.
PubMed 10641694
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05612139
- Acronym / sponsor ID
- JTIN / OCI_2201
- Conditions
- Osteogenesis Imperfecta
- Keywords
- nailing, nail, Osteogenesis, pediatric, bone, rare disease, brittle, telescopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Orthofix s.r.l.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Detailed description
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 "Visits and Assessments Schedule"). 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JTIN treated patients | – | Device: JTIN implantation surgeryPediatric patients, older than 18 months, suffering from osteogenesis imperfecta treated with JTIN telescopic nail |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients older than 18 months suffering from osteogenesis imperfecta.
Key inclusion criteria (5 listed)
- 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;
- patient and/or legal representative is duly informed and doesn't oppose to participation.
Key exclusion criteria (5 listed)
- has a medical condition that is a contraindication according to the manufacturer's instruction for use;
- has any conditions that in the Investigator's opinion may 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 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);
- is likely to be lost to follow up, according to investigator's opinion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JTIN implantation surgeryThe JTIN is a self-extending intramedullary nail (telescopic rod) designed to provide 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. These two components slide from each other, allowing for extension of the JTIN as the bone structures remodel and patient growth occurs. | Device | JTIN treated patients |
Primary outcome
Percentage of Procedures With at Least One Serious/Not Serious Adverse Event Certainly or Possibly Related to JTIN
Time frame: 1 year
The primary endpoint is measured to evaluate the clinical safety profile of JTIN within the scope of its intended purpose.
3 secondary outcomes
Implant Survival Rate: Percentage of Not Exchanged Nails
Time frame: 1 year
Percentage of Procedures With Bone Union Achievement
Time frame: 1 year
Post-treatment Fracture-free Survival Rate
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27379783Azzam 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.
- Background: PubMed 21572286Birke 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.
- Background: PubMed 10641694Novacheck TF, Stout JL, Tervo R. Reliability and validity of the Gillette Functional Assessment Questionnaire as an outcome measure in children with walking disabilities. J Pediatr Orthop. 2000 Jan-Feb;20(1):75-81.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zagorka Pejin, MD principal investigator
Necker-Enfants Malades Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteogenesis Imperfecta, run by Orthofix s.r.l. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Procedures With at Least One Serious/Not Serious Adverse Event Certainly or Possibly Related to JTIN (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612139, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.