A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System

Launched by CHRISTIAN CANDRIAN · Jul 28, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new system called ADAPT, which helps surgeons perform better surgeries for patients with a specific type of hip fracture known as a proximal femur fracture. The ADAPT system uses special software to create a 3D image of the hip without exposing patients to extra radiation. This technology helps surgeons place screws more accurately and may also make the surgery quicker and safer.

To participate in this study, you need to be between 50 and 85 years old and be having surgery for a hip fracture at a specific hospital in Lugano. You should also have a body mass index (BMI) between 18 and 35 and be able to understand and follow the study procedures. If you join the study, you can expect to receive care that may help improve your surgery experience. However, certain medical conditions or personal circumstances might prevent you from participating, such as severe health issues or difficulties in following the study's requirements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients undergoing unilateral primary intramedullary nailing at the Ospedale Regionale di Lugano.
• • Patients aged 50-85 years old.
• • Patients with a BMI \>18 and \<35.
• • Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
• • Radiological evidence of proximal fracture of the femur, AO classified as 31 A1.3, 31 A2.1, 31 A2.2, 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3.
• Exclusion Criteria:
• • Other clinically significant concomitant disease states (e.g. renal failure, major hepatic dysfunction, life-threatening cardiovascular disease, etc..).
• • Known or suspected non-compliance, drug or alcohol abuse.
• • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• • Previous enrolment into the current study.
• • Enrolment of the investigator, his/her family members, employees and other dependent persons.