MedTrace Logo

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

NCT01847898 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-03-14

No results posted yet for this study

Summary

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.

Conditions

  • Vertebral Body Fractures

Interventions

PROCEDURE

Vertebral Body Stenting (VBS)

Vertebral Augmentation with a Stent

PROCEDURE

Balloon Kyphoplasty

Vertebral Augmentation with a Balloon (device not specified)

Sponsors & Collaborators

  • Synthes GmbH

    lead INDUSTRY

Principal Investigators

  • Paul F. Heini, Prof. Dr. med. · Klinik Sonnenhof, Bern, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-01
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847898 on ClinicalTrials.gov