Status:
RECRUITING
A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System
Lead Sponsor:
Christian Candrian
Conditions:
Femoral Fracture
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head without additional radiation. It automatically detects the used implant and its position relative to the f...
Detailed Description
This study is a 2-arm randomized controlled trial comparing intramedullary nailing 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) pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04494672
Start Date
September 28 2020
End Date
August 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Christian Candrian
Lugano, Switzerland, 6900