Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT04056351
Eligibility Criteria:
Inclusion Criteria:
* Ageā„ 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04056351
Study Brief:
Protocol Section:
NCT04056351