Fracture Monitor - Femur

Launched by AO INNOVATION TRANSLATION CENTER · Jun 7, 2022

Keywords

ClinConnect Summary

The Fracture Monitor - Femur trial is studying a new device called the Fracture Monitor T1, which is designed to help doctors understand more about femoral fractures (thigh bone fractures) and how well the treatment works. The study will involve 37 patients who have been diagnosed with a femoral fracture that requires surgery with a specific type of plate. During the surgery, the Fracture Monitor will be attached to the plate, and after surgery, it will connect to a smartphone app to collect data on the healing process. This information will be securely stored and reviewed to ensure the device is safe and effective, but neither the patients nor their doctors will see the data during recovery to avoid influencing treatment decisions.

To be eligible for this trial, participants must be 18 years or older, have a specific type of femoral fracture, and be able to bear weight after surgery. They should also be willing to undergo a second surgery to remove the monitor if it is not taken out during the first surgery. Throughout the study, participants will receive standard care, and their safety will be monitored for six months after surgery. This trial aims to gather valuable safety and performance information about the Fracture Monitor T1, which could help improve treatments for future patients with similar injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older
• • Closed growth plates at time of injury
• * Femoral fracture requiring osteosynthesis and treated with one of the following plates:
• • DePuy Synthes LCP® 4.5/5, Broad
• • DePuy Synthes LCP® 4.5/5, Broad Curved
• • DePuy Synthes LCP® Condylar Plate 4.5/5.0
• • DePuy Synthes VA-LCP® Condylar Plate 4.5/5.0
• • DePuy Synthes LCP® Distal Femur
• • DePuy Synthes LCP® Proximal Femoral Plate 4.5/5.0
• • DePuy Synthes LCP® Proximal Femur Hook Plate
• • 41medical AG, Biphasic Plate DF
• • ASA score 1-3
• • Full weight-bearing capacity prior to the injury
• • The patient is foreseen to be capable of postoperative weight bearing of at least 15 kg
• • Willingness to undergo an additional surgery to remove the Fracture Monitor T1 if its removal is not done together with the fixation plate within two years according to standard of care
• • Ability to provide written informed consent
• Preoperative exclusion Criteria:
• • Concomitant fractures in the contralateral leg
• • Electromagnetic hypersensitivity
• • Implanted electromagnetic bone stimulators
• • Pregnancy (determined by pregnancy test)
• • Prisoner
• • Known history of substance abuse (eg, recreational drugs and alcohol) that would preclude reliable assessments
• • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present clinical investigation
• Intraoperative exclusion criteria:
• • Use of compression lag screw across fracture fragment
• • Compression osteosynthesis
• • Precontouring of implant at the area of the attachment of Fracture Monitor T1
• • Double-plating technique
• • Soft-tissue coverage \> 6 cm above the data logger
• • Concurrent use of intramedullary nail
• • Patients foreseen to require magnetic resonance imaging scanning at any part of the body or shockwave therapy at the proximity of the Fracture Monitor T1
• • Fracture Monitor T1 not functional according to the instruction for use (IFU, section 24, A) and no functional replacement implant available