Clinical Trials Directory

Trials / Completed

CompletedNCT01143675

Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures

The Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures

Status
Completed
Phase
Study type
Observational
Enrollment
148 (actual)
Sponsor
AO Clinical Investigation and Publishing Documentation · Academic / Other
Sex
All
Age
50 Years – 90 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with proximal humerus fractures treated with open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).

Detailed description

More than 70% of patients with a proximal humerus fracture are older than 60 years, up to three quarters are women and the incidence of low-energy fractures increases exponentially with age. The standard diagnostic method for classifying osteoporosis is the measurement of Bone Mineral Density at specific body sites - hip, vertebra or distal radius. Despite the fact that osteoporotic fractures are very frequent at the shoulder, no study investigated the correlation between local bone quality and fracture treatment at the proximal humerus. There is a concern among the clinicians that osteoporotic bone in proximal humerus fractures increases the risk of treatment complications. However, to our knowledge this has not yet been evaluated in clinical studies. One major reason for this lack of studies is the fact that no standardized method exists for the determination of bone density at the proximal humerus.

Conditions

Timeline

Start date
2007-03-01
Primary completion
2010-04-01
Completion
2010-04-01
First posted
2010-06-14
Last updated
2020-08-12

Locations

10 sites across 4 countries: Austria, China, Germany, Switzerland

Source: ClinicalTrials.gov record NCT01143675. Inclusion in this directory is not an endorsement.