A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System
NCT ID: NCT04494672
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2020-09-28
2025-08-01
Brief Summary
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Detailed Description
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The ADAPT system has been developed with the aim to reduce the rate of complications in intramedullary nailing and its usefulness has been previously explored only in two underpowered randomized controlled trials. Thanks to the possibility to track screw placement in real-time, allowing improved screw placement, the ADAPT system could be a valid tool, in order to minimize radiation exposure, surgical time, and rate of complications.
All the patients undergoing intramedullary nailing at the Ospedale Regionale di Lugano satisfying the eligibility criteria reported at section 7.1 will be enrolled in the study and randomly allocated (allocation ratio 1:1) to receive preoperatively:
* Intramedullary nailing with ADAPT system (arm-A)
* Intramedullary nailing without ADAPT system (arm-B) Patients and physicians evaluating the results will be blinded to the assigned group.
The total number of patients enrolled will be 96 (48 arm-A, 48 arm-B). After surgery, data about duration of the procedure, intraoperative blood loss, satisfaction of the surgeon and radiation exposure time will be collected.
Fracture healing, and rate of complications (cut-through and cut out) will be evaluated during all the follow-up visits, alongside VAS and a functional evaluation of the injured hip through the Oxford Hip score.
All treatment related adverse events will be reported up to follow-up visit 4, i.e. up to 12 ± 1 months.
Every patient will be involved in the trial for 1 year. The expected time to complete the trial is 4 years: 3 years for patient enrolment and 1 year to complete the last follow-up
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intramedullary nailing with ADAPT system (arm-A)
A commercial product, namely ADAPT will be used as investigation product in arm-A
Intramedullary 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
Intramedullary nailing without ADAPT system (arm-B)
No aid in performing intramedullary nailing for proximal femoral fractures will be implemented in arm-B
Intramedullary nailing without ADAPT system
Intramedullary nailing without ADAPT system
Interventions
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Intramedullary 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
Intramedullary nailing without ADAPT system
Intramedullary nailing without ADAPT system
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
85 Years
ALL
No
Sponsors
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Christian Candrian
OTHER
Responsible Party
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Christian Candrian
Prof. Dr. Med.
Principal Investigators
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Christian Candrian, MD
Role: PRINCIPAL_INVESTIGATOR
Ente Ospedaliero Cantonale, Bellinzona
Locations
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Christian Candrian
Lugano, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ORL-ORT-015
Identifier Type: -
Identifier Source: org_study_id
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