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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 up to 5 years
Awards & highlights
No Placebo-Only Group

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 ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

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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.
~12 spots leftby Nov 2025