Trial Outcomes & Findings for Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients (NCT NCT05612139)

Results Overview

The primary endpoint is measured to evaluate the clinical safety profile of JTIN within the scope of its intended purpose.

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

1 year

Results posted on

2026-01-26

Participant Flow

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.

Unit of analysis: implants (i.e. procedures)

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	14 25
Overall Study COMPLETED	14 25
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JTIN Treated Patients n=14 Participants 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.
Age, Continuous Age at surgery	5.4 years STANDARD_DEVIATION 3.0 • n=14 Participants
Age, Continuous Age at study inclusion	7.5 years STANDARD_DEVIATION 3.0 • n=14 Participants
Sex: Female, Male Female	5 Participants n=14 Participants
Sex: Female, Male Male	9 Participants n=14 Participants
Region of Enrollment France	14 Participants n=14 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 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.

The primary endpoint is measured to evaluate the clinical safety profile of JTIN within the scope of its intended purpose.

Outcome measures

Outcome measures
Measure	JTIN Treated Patients n=25 Implants (i.e. procedures) 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.
Percentage of Procedures With at Least One Serious/Not Serious Adverse Event Certainly or Possibly Related to JTIN	4.0 percentage of procedures Interval 0.1 to 20.4

SECONDARY outcome

Timeframe: 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure	JTIN Treated Patients n=25 Implants (i.e. procedures) 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.
Implant Survival Rate: Percentage of Not Exchanged Nails	100.0 percentage of not exchanged nails Interval 86.3 to 100.0

SECONDARY outcome

Timeframe: 1 year

Population: 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.

This endpoint is measured to evaluate the clinical performance of JTIN.

Outcome measures

Outcome measures
Measure	JTIN Treated Patients n=25 Implants (i.e. procedures) 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.
Percentage of Procedures With Bone Union Achievement	100.0 percentage of procedures Interval 86.3 to 100.0

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Outcome measures
Measure	JTIN Treated Patients n=14 Participants 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.
Post-treatment Fracture-free Survival Rate	35.7 percentage of patients Interval 12.8 to 64.9

Adverse Events

JTIN Treated Patients

Serious events: 9 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	JTIN Treated Patients n=14 participants at risk 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.
Musculoskeletal and connective tissue disorders Non-union, delayed union or malunion	14.3% 2/14 • Number of events 2 • 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.
Injury, poisoning and procedural complications Bone fracture during or after treatment	50.0% 7/14 • Number of events 7 • 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.
Injury, poisoning and procedural complications Migration of the device	7.1% 1/14 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	JTIN Treated Patients n=14 participants at risk 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.
Injury, poisoning and procedural complications Bone fracture during or after treatment	71.4% 10/14 • Number of events 17 • 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.
Injury, poisoning and procedural complications Pain, discomfort or abnormal sensations due to the presence of the device	14.3% 2/14 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Residual deformities, persistence or recurrence of the initial condition subject to treatment	7.1% 1/14 • Number of events 1 • 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.
Injury, poisoning and procedural complications Stiffness at surgery site	7.1% 1/14 • Number of events 1 • 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.

Additional Information

Clinical Affairs Operation

Orthofix s.r.l.

Phone: +39 045 6719000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER