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

Status unconfirmed · Not applicable

Conditions studied: Spinal Fractures

In brief

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.

Key facts

Study ID

NCT00290862

Run by

Orthovita d/b/a Stryker

People needed

256

Starts

2004-09-01

Expected to finish

2009-03-01

Last updated by the study team

2008-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Are at least 18 years of age
• Have sustained a painful osteoporotic vertebral compression fracture (VCF) for at least 4 weeks but no longer than 1 year or have radiographic evidence of at least 5% worsening vertebral collapse as compared to previous radiographic evidence
• Give written Informed Consent to participate in the study and be willing to comply with protocol requirements
• Have pain requiring the regular use of analgesics or have a substantially altered life-style due to pain or disability
• Have central pain over the spinous process upon palpation at the planned level(s)
• Are appropriately communicative to verbalize and differentiate with regard to location and intensity of their pain
• Are physically and mentally willing and able to comply with the clinical and radiographic follow-up schedule
• Have radiographic evidence of one or two, Grade 1 or greater according to Genant's criteria, osteoporotic VCF(s) between (and including) the level of the sixth (6th) thoracic to the fifth (5th) lumbar
• Have an acute or persistent (not healed) fracture demonstrated by magnetic resonance imaging (MRI) or bone scan
• Have a patient self-assessment VAS score >= 50 mm at the pre-treatment visit
• Have a 30% or greater disability score on the baseline ODI (version 2.0).

You may not qualify if…

• Have significant vertebral collapse defined as more than 70% of original vertebral height, or a burst or pedicle fracture with posterior cortical wall disruption
• Have posterior vertebral wall displacement occupying more than 20% of the cross sectional area of the spinal canal
• Have neurologic symptoms or deficits, or radiculopathy related to the VCF
• Have pain based on a clinical diagnosis of herniated nucleus pulposus, high energy trauma, severe spinal stenosis as evidenced by progressive weakness or paralysis, or bone tumor at the level(s) of pathology as evidenced by computed tomography (CT) scan
• Have indications of instability related to the VCF at the level to be treated (e.g., neurologic deficit, kyphosis > 30º, translation > 4 mm, and/or interspinous process widening)
• Have canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level(s) to be treated
• Have a bleeding disorder, including coagulopathy
• Have severe cardiopulmonary deficiencies
• Have an active systemic or local infection
• Are currently being treated for cancer or HIV
• Have a known allergy to acrylics (e.g., methyl methacrylate)
• Subject is currently an alcohol, solvent or drug abuser
• Female patients who are pregnant or nursing, or of childbearing potential not using a reliable contraceptive method
• Are involved in medical litigation
• Are prisoners
• Have participated in another investigational study within 30 days prior to inclusion

Where it is running

• Scottsdale Medical Center — Scottsdale, Arizona, United States
• Core Orthopaedic Medical Center, P.C. — Encinitas, California, United States
• Eisenhower Medical Center — Rancho Mirage, California, United States
• St. John's Spine Institute — Santa Monica, California, United States
• Indian River Radiology — Vero Beach, Florida, United States
• Emory Orthopaedics and Spine Center — Atlanta, Georgia, United States
• Millenium Pain Center — Bloomington, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• The Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Washington University Medical Center — St Louis, Missouri, United States
• Hospital for Special Surgery (HSS) — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Mission Hospitals — Asheville, North Carolina, United States
• Dayton Interventional Radiology — Kettering, Ohio, United States
• Edmond Medical Center — Oklahoma City, Oklahoma, United States
• Mercy Health Center — Oklahoma City, Oklahoma, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Endovascular Center of Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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