Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients

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.

Inclusion Criteria:is in pediatric age ((> 18 month and < 18 years) at the time of ICF 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;is compliant in participating to the study and the legal representative/guardian is compliant in signing the ICF .Exclusion Criteria: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;is likely to be lost to follow up, according to investigator's opinion.