Status:
COMPLETED
PHILOS Augmented - a Multicenter Randomized Controlled Trial
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Humerus Fractures
Closed Fracture of the Proximal Humerus
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The primary objective is to compare the mechanical failure risks in the first year after treatment.
Detailed Description
Biomechanical tests have shown that augmentation of screws or nails with polymethylmethacrylate (PMMA) leads to increased mechanical properties of the bone-implant complex, leading to the assumption t...
Eligibility Criteria
Inclusion
- Age ≥ 65 years
- Low energy trauma (e.g. 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 (i.e. segment dis-placement \> 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 fol-low-up procedures
- Signed informed consent
- Preoperative
Exclusion
- 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 (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
- Intraoperative
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01847508
Start Date
October 1 2013
End Date
July 1 2018
Last Update
August 13 2020
Active Locations (9)
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1
Medical University of Innsbruck
Innsbruck, Austria, 6020
2
UZ Leuven
Leuven, Belgium, 3000
3
University Hospital RWTH Aachen
Aachen, Germany, 52074
4
University Medical Center Freiburg
Freiburg im Breisgau, Germany, 79095