RecruitingNot ApplicableNCT04494672

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

Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial

Sponsor

Christian Candrian

Enrollment

96 participants

Start Date

Sep 28, 2020

Study Type

INTERVENTIONAL

Conditions

Femoral Fracture

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 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

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria5

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.

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Interventions

PROCEDUREIntramedullary nailing with ADAPT system

Stryker ADAPT®system (ADAPT, Stryker Leibinger GmbH \& Co. KG, Freiburg, Germany) is a computer navigation system which can reconstruct a 3D model of the femoral head from the positional information oriented by bidirectional fluoroscopic views. ADAPT shows the distance from the tip of the screw to the surface of the femoral head, tip-to-head-surface distance (TSD), and tip-apex distance (TAD) intraoperatively

PROCEDUREIntramedullary nailing without ADAPT system

Intramedullary nailing without ADAPT system