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Corticosteroid

CORTOSS for Spinal Fracture

N/A
Waitlist Available
Research Sponsored by Orthovita d/b/a Stryker
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

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.

Eligible Conditions
  • Spinal Fracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Early and sustained decrease in pain (efficacy prong of primary endpoint) at 24 months compared to pre-treatment baseline using the Visual Analog Scale (VAS)
Maintenance or improvement in function (efficacy prong of primary endpoint) at 24 months compared to pre-treatment baseline using the Oswestry Disability Index (ODI)
Maintenance vertebral height and alignment (efficacy prong of primary endpoint) at 24 Months compared to 1-month post-vertebropalsty baseline radiographs
+1 more
Secondary outcome measures
Ambulatory status
Maintenance or improvement in quality of life (secondary endpoint) at 24 months compared to baseline using the SF-12
Patient satisfaction

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CORTOSSExperimental Treatment1 Intervention
Patients prospectively randomized to be treated with Cortoss constitute treatment group.
Group II: PMMAActive Control1 Intervention
Patients prospectively randomized to be treated with PMMA constitute active control group.

Find a Location

Who is running the clinical trial?

Orthovita d/b/a StrykerLead Sponsor
4 Previous Clinical Trials
380 Total Patients Enrolled
Maarten Persenaire, M.D.Study DirectorOrthovita, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Georgia
How old are they?
65+
What site did they apply to?
Emory Orthopaedics and Spine Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis
2004. "A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00290862.
All > Osteoporosis
~12 spots leftby Apr 2025
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