A multicenter randomized controlled trial to investigate the treatment outcome of PHILOS Screw Augmentation compared to PHILOS without augmentation in older adult patients with proximal humerus fractures - Philos+

AO Documentation and Publishing Foundation0 个研究点目标入组 144 人开始时间: 2014年1月15日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•= 65 years
•Low energy trauma (eg, fall from standing height)
•Radiologically confirmed closed fracture (= 10 days) of the proximal humerus
•Any displaced or unstable 3- or 4-part fracture of the proximal humerus (ie, segment displacement >0.5 cm or angulated > 45°) except isolated displaced fractures of the greater or lesser tuberosity
•Primary fracture treatment with a PHILOS plate
•Ability to understand the content of the patient information / informed consent form
•Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs)
•Signed informed consent

•Bilateral or previous proximal humerus fractures on either side
•Splitting fracture of the humeral head or humeral head impression fracture
•Cuff-arthropathy of the contra- or ipsilateral proximal humerus
•Associated nerve or vessel injury
•Any known clotting disorders, severe cardiac and/or pulmonary insufficiency
•Known hypersensitivity or allergy to any of the components of Traumacem V+ Cement Kit
•Any severe systemic disease: class 4 - 6 of the American Society of Anesthesiologists (ASA) physical status classification
•Any not medically managed severe systemic disease: class 3 of the ASA physical status classification
•Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
•Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
•Intraoperative decision to use implants other than PHILOS/PHILOS Screw Augmentation

发起方

AO Documentation and Publishing Foundation