A Research Study to Understand and Predict the Failure of Shoulder Fracture Fixations Using Computer Simulations (PHILOS-SIM)
Proximal Humeral Fracture
About this trial
This is an interventional screening trial for Proximal Humeral Fracture focused on measuring humerus, fracture, locking plate, PHILOS, fixation failure risk, computer simulation, patient activity tracking
Eligibility Criteria
Inclusion Criteria:
- Age≥ 50 years
- Radiologically confirmed closed fracture of the proximal humerus and treatment within 10 days after injury
- Any displaced or unstable 3- or 4-part fracture of the proximal humerus except isolated displaced fractures of the greater or lesser tuberosity
- Completed primary fracture treatment with a PHILOS plate with or without cement augmentation of the screws
- Ability to understand the content of the patient information / informed consent form
- Willingness and ability to participate in the clinical investigation including imaging, activity tracking and other FU procedures
- Signed informed consent
Exclusion Criteria:
- Previous proximal humerus fracture on the ipsilateral side
- Splitting fracture of the humeral head or humeral head impression fracture
- Fibula grafting, bone block or any other non-cement augmentation of the PHILOS plate fixation
- Any serious fracture fixation issue (serious malreduction, too long screw or screw perforating through the humeral head, broken screw or implant) that are recognized on the immediate post-OP x-rays, independently of being re-operated or not
- Associated nerve or vessel injury
- Any severe systemic disease: class 4 - 5 of the American Society of Anesthesiologists (ASA) physical status classification
- Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- Pregnancy
- Pacemaker
Sites / Locations
- Medical University of Innsbruck
- UZ Leuven
Arms of the Study
Arm 1
Other
Cohort of 50 enrolled patients
The following visits will be performed: direct post-OP, 3 weeks, 6 weeks, 3 months and 6 months after surgery. Surgical details will be assessed from the surgical notes. Medical images will be collected according to the standard of care. A post-OP CT scan will also be acquired when the treating surgeon requests it as per standard of care, or additionally, as a study specific imaging procedure for the rest of the participants. Patient activity will be estimated based on various factors, including questionnaires on demographics, activity level, comorbidity score and contralateral grip strength. The actual post-OP shoulder activity will be measured by motion tracking by means of sensors attached to upper arm of the treated side and on the chest for 6 weeks and by grip strength assessed at the treated arm at week 6. Fixation failure status will be determined 6 months post-OP. Imaging and details regarding the fixation failure event will be sent to ARI.