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Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques

NCT02461810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2019-02-22

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.

Conditions

  • Spinal Fractures
  • Vertebral Compression Fractures
  • Back Injuries
  • Osteoporosis

Interventions

DEVICE

Vertebral fracture surgery SpineJack®

Vertebral augmentation for one osteoporotic vertebral compression fracture

PROCEDURE

Balloon Kyphoplasty

Sponsors & Collaborators

  • ACES Ing.-GmbH

    collaborator OTHER

  • Vexim SA

    lead INDUSTRY

Principal Investigators

  • Marie-Pierre HONTAS, Director Clinical Affairs · Vexim SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-02-20
Completion
2018-02-20

Countries

  • France
  • Germany
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT02461810 on ClinicalTrials.gov