DRKS00005261
Recruiting
未知
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 sites144 target enrollmentJanuary 15, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Proximal humerus fractures
- Sponsor
- AO Documentation and Publishing Foundation
- Enrollment
- 144
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\= 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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