Status:
COMPLETED
A Research Study to Understand and Predict the Failure of Shoulder Fracture Fixations Using Computer Simulations
Lead Sponsor:
AO Research Institute Davos
Conditions:
Proximal Humeral Fracture
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Fractures of the shoulder, the so-called proximal humeral fractures, can be treated with locking plates that have shown good results in clinical practice, but complications can occur. In order to furt...
Detailed Description
Older adult patients with complex, displaced and/or unstable proximal humerus fractures treated with the PHILOS plate (DePuy Synthes Inc.) will be recruited. Detailed patient background information wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04056351
Start Date
August 2 2019
End Date
December 31 2022
Last Update
February 1 2023
Active Locations (2)
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1
Medical University of Innsbruck
Innsbruck, Austria
2
UZ Leuven
Leuven, Belgium