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.