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PHILOS Augmented - a Multicenter Randomized Controlled Trial

NCT01847508 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-08-13

No results posted yet for this study

Summary

The primary objective is to compare the mechanical failure risks in the first year after treatment.

Conditions

  • Humerus Fractures
  • Closed Fracture of the Proximal Humerus

Interventions

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).

Sponsors & Collaborators

  • AO Clinical Investigation and Publishing Documentation

    lead OTHER

Principal Investigators

  • Andreas Faeh · AO Clinical Investigation and Documentation, Davos, Switzerland

  • Franz Kralinger, PD, MD · Medical University of Innsbruck, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-11-03
Completion
2018-07-31

Countries

  • Austria
  • Belgium
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847508 on ClinicalTrials.gov