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NCT01847898

Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting

Completed Phase 4 Last updated 14 March 2017
What this trial tests

Phase 4 trial testing Vertebral Body Stenting (VBS) in Vertebral Body Fractures in 100 participants. Completed in 31 December 2015.

Timeline
1 September 2009
Primary endpoint
31 December 2015
31 December 2015

Quick facts

Lead sponsorSynthes GmbH
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment100
Start date1 September 2009
Primary completion31 December 2015
Estimated completion31 December 2015
Sites5 locations across Austria, Germany

Drugs / interventions tested

Conditions studied

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.

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Other Synthes GmbH trials

Trials by the same sponsor.

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Data sources for this page

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