Multicenter Retrospective Observational Study to Assess the Clinical Performance and Safety Profile of Agile Nail in Paediatric Patients Who Have Suffered Femoral Shaft and Subtrochanteric Fractures or Have Performed Prophylactic Nailing of Impending Pathologic Fractures or Have Undergone Fixation of Femurs That Have Been Surgically Prepared for Deformity Correction: Agile Study

The study will be conducted in two investigational sites, one in France and one in United Kingdom, both experienced in the treatment of pediatric patients with femoral shaft and subtrochanteric fractures and deformity correction procedures or have performed prophylactic nailing of impending pathologic fractures, where the usage of AGILE NAIL (known as AGILE) was part of the normal clinical practice.

Investigator of both study sites will provide data for a maximum of 45 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 45 procedures in which AGILE 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 AGILE implantation from 04/2018 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.