NCT01847508

PHILOS Augmented - a Multicenter Randomized Controlled Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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 that augmentation could reduce mechanical failures in patients. While a few clinical studies have already been performed with augmented trochanteric nails in proximal femur fractures, no clinical studies exist with the use of Proximal Humerus Internal Locking System (PHILOS) and (PMMA) augmentation for the treatment of fractures in the proximal humerus. In this study a new standardized technique for augmentation of screw tips using high viscous PMMA cement (Traumacem V+) with the PHILOS plate will be applied. Fracture treatment with PHILOS Screw Augmentation will be compared with treatment with PHILOS without augmentation.

Conditions

• Humerus Fractures
• Closed Fracture of the Proximal Humerus

Interventions

Type	Name	Description
DEVICE	PHILOS+	Proximal Humerus Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).
DEVICE	PHILOS	Proximal Humerus Internal Locking System (PHILOS).

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-11-03
• Completion: 2018-07-01
• First posted: 2013-05-07
• Last updated: 2020-08-13

Locations

9 sites across 4 countries: Austria, Belgium, Germany, Switzerland