Stopped: This observational, retrospective study was discontinued as part of a strategic decision to reallocate resources to new product development. All patients had completed treatment before the study start.
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.
Age range
18 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Percentage of procedures that have achieved bone union at the "bone consolidation assessment" visit
Timeframe: 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)
Timeframe: 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
Timeframe: from the date of surgery until the last follow-up, assessed up to 1 year
Post-treatment fracture-free survival
Timeframe: up to 1 year