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A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis

NCT00290862 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2008-10-15

No results posted yet for this study

Summary

Doctors are studying an investigational treatment to be used during the vertebroplasty procedure when treating vertebral compression fractures (spine fractures) that may help to reduce pain and restore mobility. If one has experienced back pain for at least 4 weeks but not longer than 1 year, he/she may be eligible to participate.

The purpose of this protocol is to describe the methods for the clinical evaluation of Cortoss for vertebroplasty in patients with painful osteoporotic compression fractures.

Eligible patients with painful osteoporotic compression fractures of the spine are divided into two groups. Each enrolled patient will have the vertebroplasty procedure; however one group of patients will have the vertebroplasty procedure using polymethylmethacrylate \[PMMA\] (a Food and Drug Administration \[FDA\]-approved bone cement) and the other group of patients will have the vertebroplasty procedure using a relatively new (investigational) biomaterial called Cortoss.

Conditions

  • Spinal Fractures

Interventions

DEVICE

Percutaneous Vertebral Augmentation of compression fractures

Study eligible patients with painful osteoporotic compression fractures will be randomized to percutaneous vertebroplasty with CORTOSS (treatment group) or PMMA (active control group).

Sponsors & Collaborators

  • Orthovita d/b/a Stryker

    lead INDUSTRY

Principal Investigators

  • Maarten Persenaire, M.D. · Orthovita, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Completion
2009-03-31

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 NCT00290862 on ClinicalTrials.gov