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

NCT05612139 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2026-01-26

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Orthofix s.r.l.

    lead INDUSTRY

Principal Investigators

  • Zagorka Pejin, MD · Necker-Enfants Malades Hospital

Eligibility

Min Age
18 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-27
Primary Completion
2025-02-20
Completion
2025-02-20

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05612139 on ClinicalTrials.gov