NCT06412913

Retrospective Study on Clinical Performance and Safety Profile of MJ-Flex Elastic Nail

Multicenter Retrospective Observational Study to Assess the Clinical Performance and Safety Profile of MJ-FLEX in Paediatric Patients Who Have Suffered Diaphyseal Fractures of Long Bones in Daily Practice: MJ-FLEX Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Orthofix s.r.l. · Industry
• Sex: All
• Age: 18 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the MJ-FLEX elastic nail used in pediatric patients according to the manufacturer Instructions For Use (IFU) in the time frame from the time of surgery until the last follow-up visit available at the hospitals.

Detailed description

The study is planned to be conducted in two investigational sites, one in France and one in United Kingdom, both experienced in the treatment of pediatric patients with diaphyseal fractures in the clavicle and in upper and lower limbs, where the usage of MJ-Flex The New Metaizeau Nail (known as MJ-Flex) was part of the normal clinical practice. Investigator of both study sites will provide data for a maximum of 61 patients meeting inclusion and exclusion criteria (Considering a drop-out or a non-evaluable rate of 10% of the procedures) that will contribute for approximately 61 procedures in which MJ-Flex was used. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied. The study has been designed to analyze medical records of patients where study data was collected as part of their routine clinical practice. Therefore, patients will be retrospectively enrolled in the study. Patients who have undergone MJ-Flex implantation from 02/2018 to 12/2022 are considered for the study The observation period of study subjects will comprise from surgery until the last follow up visit available. Medical records of the participating sites are expected to contain all the required information. In United Kingdom, no study visit will be required but according to local legislation, it will be essential that before collecting any information from medical records, participants or their guardians are asked for specific informed consent to be signed by them before any collection of patient information takes place. However, in France, due to the use of primary data and the foreseen exemption of the informed consent (IC) form (see Section 14.2 Informed Consent), no study visit will be required.

Conditions

• Fractures, Bone

Interventions

Type	Name	Description
DEVICE	MJ-Flex The New Metaizeau Nail	Intramedullary implantation of the MJ-Flex elastic nail in long bones to provide bone fixation

Timeline

• Start date: 2024-07-19
• Primary completion: 2025-03-28
• Completion: 2025-03-28
• First posted: 2024-05-14
• Last updated: 2025-08-28

Locations

1 site across 1 country: United Kingdom