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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fractures, Bone
• Intervention / Treatment: Device: MJ-Flex The New Metaizeau Nail

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.

• Study Type: Observational
• Enrollment (Estimated): 61

Contacts and Locations

• Study Contact: Name: Edo Knijff; Phone Number: +390456719000; Email: EdoKnijff@orthofix.it
• Study Contact Backup: Name: Tommaso Marano; Phone Number: +390456719000; Email: tommasomarano@orthofix.it

Study Locations

• United Kingdom
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's NHS Foundation Trust
    • Contact: Sara Dorman, MD; Phone Number: +441142717000; Email: sara.dorman@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The full analysis set includes all paediatric patients who that have been treated for diaphyseal fractures of long bones with the MJ-FLEX the will be systematically consecutive screened at the centers.

Description

Inclusion Criteria:

1. The patient has been adequately informed by providing the PIS. 1.1 The patient expressed his willingness to participate in the Study by signing and dating informed consent (valid only for UK patients according to local law).
2. Patients who had a regular indication for surgical intervention with MJ-Flex according to the manufacturer's IFU.
3. Patients in pediatric age (> 18 month and < 18 years) at the time of surgery.
4. Patients skeletally immature.
5. Patients who underwent surgery performed with MJ-Flex.
6. Patients with clinical data registered in her/him medical records sufficient to assess the safety and efficacy endpoint of the study: in particular, the patient has at least one follow-up at minimum 3 months from the surgery where is possible for the investigator to assess the consolidation of the treated bone.
7. The patient had surgery at least 1 year before enrollment.

Exclusion Criteria:

1. Patient who had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet.
2. Patient who had/has a concomitant not permitted device which cannot be safely removed.
3. Patient for whom there are other concurrent medical or other conditions that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study.
4. The patient had surgery less than 1 year before enrollment.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients in pediatric age (> 18 month and < 18 years) at the time of surgery; The full analysis set includes all paediatric patients who that have been treated for diaphyseal fractures of long bones with the MJ-FLEX the will be systematically consecutive screened at the centers.	Device: MJ-Flex The New Metaizeau Nail; Intramedullary implantation of the MJ-Flex elastic nail in long bones to provide bone fixation; Other Names: Elastic Nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of procedures that have achieved bone union at the "bone consolidation assessment" visit	The measurement of efficacy will be mande with the percentage of procedures that have achieved bone union	After 5 month (approximately) from surgery
Percentage of procedures who experienced at least one MDDs that caused an effect on the patient	This outcome will be used to measure safety	from the date of surgery until the last follow-up, assessed up to 1 year
Percentage of procedures with at least one serious/not serious adverse event certainly related or possibly related to MJ-FLEX (ADEs/SADEs)	This outcome will be used to measure safety	from the date of surgery until the last follow-up, assessed up to 1 year
Post-treatment fracture-free survival	This outcome will be used to measure safety	up to 1 year

Collaborators and Investigators

• Sponsor: Orthofix s.r.l.
• Investigators: Principal Investigator: Sara Dorman, MD, Sheffield Children's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; nail; intramedullary; elastic; elastic nailing
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: OCI_2303; 334519 (Other Identifier: IRAS project ID (UK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No