Trials / Completed
CompletedNCT02461810
Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques
A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- Vexim SA · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vertebral fracture surgery SpineJack® | Vertebral augmentation for one osteoporotic vertebral compression fracture |
| PROCEDURE | Balloon Kyphoplasty |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2018-02-20
- Completion
- 2018-02-20
- First posted
- 2015-06-03
- Last updated
- 2019-02-22
Locations
13 sites across 5 countries: France, Germany, Italy, Spain, Switzerland
Source: ClinicalTrials.gov record NCT02461810. Inclusion in this directory is not an endorsement.