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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorChristian Candrian

About this trial

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 femoral head, helping the surgeon to achieve an optimal proximal screw positioning in the femoral head. The investigators want to verify if with the addition of the ADAPT system the investigators can improve screw placement and reduce surgery time and radiation exposure.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intramedullary nailing with ADAPT system
  • Intramedullary nailing without ADAPT system

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Christian Candrian

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution