Prospective First in Human Clinical Investigation to Evaluate the Safety of the Fracture Monitor T1 in Patients with Femur Fractures Treated with a Locking Compression Plate

What this Trial Is About

Researchers are evaluating the safety and performance of the Fracture Monitor T1, an implantable device used in patients with femoral fractures treated with locking compression plates. This prospective interventional study involves 37 patients who will be monitored to collect safety data and assess device handling and usability. The study aims to provide important clinical evaluation data for regulatory approval and improved fracture treatment monitoring. During surgery, the Fracture Monitor T1 device will be attached to the locking plate used for femoral fracture fixation. Before hospital discharge, the device will be connected to a smartphone app, either on the patient's phone or one provided by the sponsor. The device continuously collects data sent via Bluetooth to an encrypted cloud server. The app will have a basic interface without data visualization, and neither patients nor surgeons will access the data during rehabilitation to avoid influencing treatment decisions. Participants will be followed for 6 months after surgery as per standard care, including monitoring of adverse events and device performance measures related to implant load and bone healing. If device removal occurs after 6 months, an additional safety follow-up will be conducted. The study includes clinical assessments, patient-reported outcomes, and radiographic scores, with all data compiled into a clinical evaluation report.

Fracture Monitor - Femur