Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Pati… (NCT05612139) | Clinical Trial Compass
CompletedNot Applicable
Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
France14 participantsStarted 2024-08-27
Plain-language 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.
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.
Who can participate
Age range18 Months – 18 Years
SexALL
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Inclusion Criteria:
* 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.
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 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.
What they're measuring
1
Percentage of Procedures With at Least One Serious/Not Serious Adverse Event Certainly or Possibly Related to JTIN