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

Sponsor: Christian Candrian • ClinicalTrials.gov ID: NCT04494672

Registry updated: 2026-09-09

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Description

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.

Interventions

Intramedullary nailing with ADAPT system (Procedure)
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
Intramedullary nailing without ADAPT system (Procedure)
Intramedullary nailing without ADAPT system

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.

Conditions

Femoral Fracture

Locations

Christian Candrian — Lugano, Switzerland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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