Spinal Fractures Clinical Trial
Official title:
A Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of CORTOSS® Synthetic Cortical Bone Void Filler in Vertebral Augmentation
Verified date | October 2008 |
Source | Orthovita d/b/a Stryker |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Unknown status |
Enrollment | 256 |
Est. completion date | March 2009 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mission Hospitals | Asheville | North Carolina |
United States | Emory Orthopaedics and Spine Center | Atlanta | Georgia |
United States | Millenium Pain Center | Bloomington | Illinois |
United States | Montefiore Medical Center | Bronx | New York |
United States | Northwestern University | Chicago | Illinois |
United States | Core Orthopaedic Medical Center, P.C. | Encinitas | California |
United States | Endovascular Center of Houston | Houston | Texas |
United States | Dayton Interventional Radiology | Kettering | Ohio |
United States | Hospital for Special Surgery (HSS) | New York | New York |
United States | Edmond Medical Center | Oklahoma City | Oklahoma |
United States | Mercy Health Center | Oklahoma City | Oklahoma |
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | Eisenhower Medical Center | Rancho Mirage | California |
United States | St. John's Spine Institute | Santa Monica | California |
United States | Scottsdale Medical Center | Scottsdale | Arizona |
United States | The Spine Institute of Louisiana | Shreveport | Louisiana |
United States | Washington University Medical Center | St. Louis | Missouri |
United States | Indian River Radiology | Vero Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Orthovita d/b/a Stryker |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 24 Months | ||
Primary | Maintenance or improvement in function (efficacy prong of primary endpoint) at 24 months compared to pre-treatment baseline using the Oswestry Disability Index (ODI) | 24 Months | ||
Primary | Maintenance vertebral height and alignment (efficacy prong of primary endpoint) at 24 Months compared to 1-month post-vertebropalsty baseline radiographs | 24 Months | ||
Primary | No device-related subsequent surgical intervention at study treated level | 24 Months | ||
Secondary | Maintenance or improvement in quality of life (secondary endpoint) at 24 months compared to baseline using the SF-12 | 24 Months | ||
Secondary | Ambulatory status | 24 Months | ||
Secondary | Patient satisfaction | 24 Months |
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