Trials / Completed
CompletedNCT01847898
Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting
Study to Evaluate the Clinical Performance of the VBS System for the Treatment of Osteoporotic Vertebral Fractures in a Multicenter, Randomized, Controlled Setting
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Synthes GmbH · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine. The randomized, controlled trial (RCT) will compare patients with VBS and Balloon Kyphoplasty.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Vertebral Body Stenting (VBS) | Vertebral Augmentation with a Stent |
| PROCEDURE | Balloon Kyphoplasty | Vertebral Augmentation with a Balloon (device not specified) |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2015-12-31
- Completion
- 2015-12-31
- First posted
- 2013-05-07
- Last updated
- 2017-03-14
Locations
5 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT01847898. Inclusion in this directory is not an endorsement.