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.
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.
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.
Parallel
Intramedullary nailing with ADAPT system
Procedure/SurgeryStryker 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/SurgeryIntramedullary nailing without ADAPT system
TAD (tip to apex) index at the post-operative X-Ray control prior discharge
The primary outcome of the study is the TAD (tip to apex) index at the post-operative X-Ray control prior discharge. The TAD is the tip-apex distance, which is the sum of the distance from the tip of the lag screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. The percentage of cut-outs has been correlated directly to both the severity of proximal femoral fractures and the TAD.
time of the procedure
time
intraoperative blood loss
intraoperative blood loss
intraoperative radiation time
intraoperative radiation time
surgeon satisfaction on the satisfaction Numerical Rating Scale (NRS scale)
The satisfaction NRS is a self-assessment scale in which surgeons rate their satisfaction on an 11-point numerical scale from 0 (completely dissatisfied) to 10 (completely satisfied). The satisfaction NRS will be administered after surgery
re-fracture rates
re-fracture rates
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Christian Candrian
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Sponsor institution
