Clinical trial
FREE Study - Fracture Reduction Evaluation
NCT00211211 · Medtronic Spine LLC, Industry · Completed
Key facts
| NCT number | NCT00211211 |
|---|---|
| Title | FREE Study - Fracture Reduction Evaluation |
| Official title | 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 |
| Lead sponsor | Medtronic Spine LLC, Industry |
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Osteopenia, Osteoporosis, Multiple Myeloma, Bone Neoplasms |
| Intervention type | Device |
| Interventions | Balloon Kyphoplasty |
| Enrollment | 300 |
| Start date | Feb 1, 2003 |
| Primary completion | Dec 1, 2007 |
| Completion | Dec 1, 2007 |
| First posted | Sep 21, 2005 |
| Last update posted | Dec 8, 2017 |
| Countries | United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: