Trials / Completed
CompletedNCT00211211
FREE Study - Fracture Reduction Evaluation
An International Multicentric, Multidisciplinary Prospective and Randomized Study to Compare Minimally Invasive Reduction and Fixation Using the KyphX System and Radiopaque PMMA Cement to Medical Therapy Alone for the Treatment of Painful, Acute Osteopenic Vertebral Body Compression Fractures
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (planned)
- Sponsor
- Medtronic Spine LLC · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Balloon Kyphoplasty |
Timeline
- Start date
- 2003-02-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2005-09-21
- Last updated
- 2017-12-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00211211. Inclusion in this directory is not an endorsement.