An observational study in Osteogenesis Imperfecta, sponsored by Orthofix s.r.l.. Completed at 1 site in France. Open to participants aged 18 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Orthofix s.r.l. · Observational
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.
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.
84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's enrollment of 14 is below the median of 75 across 23 observational studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta studies →Orthofix s.r.l. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric patients older than 18 months suffering from osteogenesis imperfecta.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric patients, older than 18 months, suffering from osteogenesis imperfecta treated with JTIN telescopic nail
Device: JTIN implantation surgery
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.
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.
Time frame: 1 year
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.
Time frame: 1 year
Percentage of Procedures With Bone Union Achievement
This endpoint is measured to evaluate the clinical performance of JTIN.
Time frame: 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.
Time frame: 1 year
The patient information and the collection of the non-opposition form could also be carried out after the patient's treatment, as the study is entirely observational and allows for the inclusion of retrospective patients. This was the case for all patients included in the study: all had undergone surgery with JTIN before the study began and were therefore informed about the study after their treatment.
| Milestone | JTIN Treated Patients |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
The primary endpoint is measured to evaluate the clinical safety profile of JTIN within the scope of its intended purpose.
| percentage of procedures | JTIN Treated Patients |
|---|---|
| Percentage of Procedures With at Least One Serious/Not Serious Adverse Event Certainly or Possibly Related to JTIN | 4.0 (0.1 to 20.4) |
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.
| percentage of not exchanged nails | JTIN Treated Patients |
|---|---|
| Implant Survival Rate: Percentage of Not Exchanged Nails | 100.0 (86.3 to 100.0) |
This endpoint is measured to evaluate the clinical performance of JTIN.
| percentage of procedures | JTIN Treated Patients |
|---|---|
| Percentage of Procedures With Bone Union Achievement | 100.0 (86.3 to 100.0) |
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.
| percentage of patients | JTIN Treated Patients |
|---|---|
| Post-treatment Fracture-free Survival Rate | 35.7 (12.8 to 64.9) |
Collected over The Adverse Event where collected from surgery to last time point indicated in the protocol (1 year + 1 month, total of 13 months post-surgery). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| JTIN Treated Patients | 0/14 (0%) | 9/14 (64.3%) | 10/14 (71.4%) |
| Event | JTIN Treated Patients |
|---|---|
| Bone fracture during or after treatmentInjury, poisoning and procedural complications | 7/14 |
| Non-union, delayed union or malunionMusculoskeletal and connective tissue disorders | 2/14 |
| Migration of the deviceInjury, poisoning and procedural complications | 1/14 |
| Event | JTIN Treated Patients |
|---|---|
| Bone fracture during or after treatmentInjury, poisoning and procedural complications | 10/14 |
| Pain, discomfort or abnormal sensations due to the presence of the deviceInjury, poisoning and procedural complications | 2/14 |
| Residual deformities, persistence or recurrence of the initial condition subject to treatmentMusculoskeletal and connective tissue disorders | 1/14 |
| Stiffness at surgery siteInjury, poisoning and procedural complications | 1/14 |
The study was performed in 14 pediatric patients who had a regular indication for surgical intervention with JTIN and in this document are reported the results obtained in 25 surgical procedures.
| Age, Continuous(years) | JTIN Treated Patients |
|---|---|
| Age at surgery | 5.4 ± 3.0 |
| Age at study inclusion | 7.5 ± 3.0 |
| Sex: Female, Male(Participants) | JTIN Treated Patients |
|---|---|
| Female | 5 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | JTIN Treated Patients |
|---|
| Region of Enrollment(Participants) | JTIN Treated Patients |
|---|---|
| France | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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