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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JTIN treated patients | Pediatric patients, older than 18 months, suffering from osteogenesis imperfecta treated with JTIN telescopic nail |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTIN implantation surgery | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients older than 18 months suffering from osteogenesis imperfecta.
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| Name | Affiliation | Role |
|---|---|---|
| Zagorka Pejin, MD | Necker-Enfants Malades Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necker-Enfants Malades Hospital | Paris | ÃŽle-de-France Region | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27379783 | Background | 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. | |
| 21572286 | Background | 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. |
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | JTIN Treated Patients | Pediatric patients, older than 18 months, suffering from osteogenesis imperfecta treated with JTIN telescopic nail 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | JTIN Treated Patients | Pediatric patients, older than 18 months, suffering from osteogenesis imperfecta treated with JTIN telescopic nail 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A total of 25 implants where analyzed on 14 recruited patients, therefore the population included in the final analysis is 25 implants and 14 patients. | Posted | Number | 95% Confidence Interval | percentage of procedures | 1 year | Implants (i.e. procedures) | Implants (i.e. procedures) |
|
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)
The investigator will follow the standard clinical practice to record data in the medical file. 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; whether or not it is Serious and whether or not it is related to the use of the investigational device and the related procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JTIN Treated Patients | Pediatric patients, older than 18 months, suffering from osteogenesis imperfecta treated with JTIN telescopic nail 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-union, delayed union or malunion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone fracture during or after treatment | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Operation | Orthofix s.r.l. | +39 045 6719000 | clinicalaffairs@orthofix.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2024 | Dec 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2025 | Dec 16, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010013 | Osteogenesis Imperfecta |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| 1 year |
| Percentage of Procedures With Bone Union Achievement | This endpoint is measured to evaluate the clinical performance of JTIN. | 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. | 1 year |
| 10641694 | Background | Novacheck 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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. | A total of 25 implants for 14 patients have been recruited, therefore the population included in the final analysis is 25 implants and 14 patients. | Posted | Number | 95% Confidence Interval | percentage of not exchanged nails | 1 year | Implants (i.e. procedures) | Implants (i.e. procedures) |
|
|
|
| Secondary | Percentage of Procedures With Bone Union Achievement | This endpoint is measured to evaluate the clinical performance of JTIN. | A total of 25 implants for 14 patients have been recruited, therefore the population included in the final analysis is 25 implants and 14 patients. | Posted | Number | 95% Confidence Interval | percentage of procedures | 1 year | Implants (i.e. procedures) | Implants (i.e. procedures) |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of patients | 1 year |
|
|
|
| 0 |
| 14 |
| 9 |
| 14 |
| 10 |
| 14 |
| Bone fracture during or after treatment | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Migration of the device | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain, discomfort or abnormal sensations due to the presence of the device | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Residual deformities, persistence or recurrence of the initial condition subject to treatment | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stiffness at surgery site | Injury, poisoning and procedural complications | Systematic Assessment |
|
The sponsor recognizes co-authors' right to publish non-commercial study results after the sponsor's first publication. Co-authors must submit manuscripts or abstracts to the sponsor at least 30 days before publication; the sponsor will provide comments within 15 working days. The sponsor and investigator may also publish results and submit data to regulatory authorities. The sponsor's identity and contribution must be disclosed in all publications.
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |