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The PRIORi-T Trial--Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation

NCT01480167 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-01-20

No results posted yet for this study

Summary

The objective of this post market clinical investigation is to evaluate the clinical effectiveness of a minimally invasive vertebral augmentation procedure, Radiofrequency-Targeted Vertebral Augmentation (RF-TVA) as compared to non-operative management (NOM) for the treatment of appropriately diagnosed acute (≤ 8 weeks) painful osteoporotic vertebral compression fractures (VCF).

Conditions

  • Painful Osteoporotic Vertebral Compression Fractures (VCF)

Interventions

DEVICE

Vertebral Augmentation (STABILIT)

Vertebral Augmentation with the STABILIT Vertebral Augmentation System

OTHER

Non-operative Management

Conservative Care

Sponsors & Collaborators

  • DFINE Inc.

    lead INDUSTRY

Principal Investigators

  • Allan Brook, M.D. · Montefiore Hospital/Einstein Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT01480167 on ClinicalTrials.gov