Trials / Completed
CompletedNCT03730207
Xpede Clinical Study
A Prospective, 1: 1 Randomized, Single Blind, Multi-center Human Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
Conditions
- Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder)
- Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Xpede™ Bone Cement | Xpede™ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae. |
| DEVICE | Mendec Spine Bone Cement | Mendec Spine Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae. |
Timeline
- Start date
- 2018-12-18
- Primary completion
- 2021-10-14
- Completion
- 2021-10-14
- First posted
- 2018-11-05
- Last updated
- 2023-01-10
- Results posted
- 2023-01-10
Locations
3 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03730207. Inclusion in this directory is not an endorsement.