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

NCT06412913 | Terminated

• 2 other identifiers: OCI_2303334519
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fractures, Bone

Keywords

nail; elastic; elastic nailing; intramedullary; pediatric

Outcome Measures

Primary Outcomes (4)

• 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 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

• 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

• Post-treatment fracture-free survival

  This outcome will be used to measure safety

  up to 1 year

Study Arms (1)

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

Interventions

MJ-Flex The New Metaizeau Nail DEVICE

Intramedullary implantation of the MJ-Flex elastic nail in long bones to provide bone fixation

Also known as: Elastic Nail

Patients in pediatric age (> 18 month and < 18 years) at the time of surgery

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).
• Patients who had a regular indication for surgical intervention with MJ-Flex according to the manufacturer's IFU.
• Patients in pediatric age (\> 18 month and \< 18 years) at the time of surgery.
• Patients skeletally immature.
• Patients who underwent surgery performed with MJ-Flex.
• 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.
• The patient had surgery at least 1 year before enrollment.

You may not qualify if:

• Patient who had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet.
• Patient who had/has a concomitant not permitted device which cannot be safely removed.
• 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.
• The patient had surgery less than 1 year before enrollment.

Sponsors & Collaborators

• Orthofix s.r.l.: lead

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Sara Dorman, MD

  Sheffield Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 14, 2024
• Study Start: July 19, 2024
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)