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NCT01847898
Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting
Phase 4 trial testing Vertebral Body Stenting (VBS) in Vertebral Body Fractures in 100 participants. Completed in 31 December 2015.
31 December 2015
Quick facts
| Lead sponsor | Synthes GmbH |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 September 2009 |
| Primary completion | 31 December 2015 |
| Estimated completion | 31 December 2015 |
| Sites | 5 locations across Austria, Germany |
Drugs / interventions tested
- Vertebral Body Stenting (VBS)
- Balloon Kyphoplasty
Conditions studied
- Vertebral Body Fractures — all drugs for Vertebral Body Fractures →
Sponsor
Synthes GmbH
Who can join
50 and older, any sex, with Vertebral Body Fractures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01847898
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01847898 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Synthes GmbH
- Last refreshed: 14 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01847898.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing