Retrospective Study on Clinical Performance and Safety Profile of MJ-Flex Elastic Nail (NCT06412913) | Clinical Trial Compass
TerminatedNot Applicable
Retrospective Study on Clinical Performance and Safety Profile of MJ-Flex Elastic Nail
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.
United Kingdom6 participantsStarted 2024-07-19
Plain-language 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.
Who can participate
Age range18 Months – 18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Patient who had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet.
What they're measuring
1
Percentage of procedures that have achieved bone union at the "bone consolidation assessment" visit
Timeframe: After 5 month (approximately) from surgery
2
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
3
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
✕. 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.