MJ-FLEX Study
Research type
Research Study
Full title
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
IRAS ID
334519
Contact name
Eduard Adrianus Knijff
Contact email
Sponsor organisation
Orthofix S.r.l.
Duration of Study in the UK
1 years, 2 months, 28 days
Research summary
The study will be conducted in two investigational sites, one in France and one in United Kingdom, both experienced in the treatment of paediatric patients with diaphyseal fractures in the clavicle and in upper and lower limbs, where the usage of the MJ-FLEX device was part of the normal clinical practice.
Investigators at 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 who have undergone MJ-FLEX implantation from February 2018 to December 2022. The observation period of study subjects will comprise from the surgery to the follow up visit after device removal.
Medical records of the participating sites are expected to contain all the required information. No study visit will be required.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
24/WM/0060
Date of REC Opinion
24 Apr 2024
REC opinion
Further Information Favourable Opinion