This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery. Aim of the study is the validation and comparison of the innovative medical device with the current standard method.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Siemens AG Healthcare Sector
Erlangen, Germany
Number of screw replacements in both treatments arms
The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B)
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
Comparison of the investigational method to the standard of care regarding radiation time.
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
Number of adverse events and serious adverse events during the clinical investigarion.
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
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