A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis
A Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of CORTOSS® Synthetic Cortical Bone Void Filler in Vertebral Augmentation
1 other identifier
interventional
256
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 10, 2006
CompletedFirst Posted
Study publicly available on registry
February 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedOctober 15, 2008
October 1, 2008
February 10, 2006
October 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
Maintenance vertebral height and alignment (efficacy prong of primary endpoint) at 24 Months compared to 1-month post-vertebropalsty baseline radiographs
24 Months
No device-related subsequent surgical intervention at study treated level
24 Months
Secondary Outcomes (3)
Maintenance or improvement in quality of life (secondary endpoint) at 24 months compared to baseline using the SF-12
24 Months
Ambulatory status
24 Months
Patient satisfaction
24 Months
Study Arms (2)
CORTOSS
EXPERIMENTALPatients prospectively randomized to be treated with Cortoss constitute treatment group.
PMMA
ACTIVE COMPARATORPatients prospectively randomized to be treated with PMMA constitute active control group.
Interventions
Study eligible patients with painful osteoporotic compression fractures will be randomized to percutaneous vertebroplasty with CORTOSS (treatment group) or PMMA (active control group).
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Scottsdale Medical Center
Scottsdale, Arizona, 85251, United States
Core Orthopaedic Medical Center, P.C.
Encinitas, California, 92024, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
St. John's Spine Institute
Santa Monica, California, 90404, United States
Indian River Radiology
Vero Beach, Florida, 32960, United States
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329, United States
Millenium Pain Center
Bloomington, Illinois, 61701, United States
Northwestern University
Chicago, Illinois, 60611, United States
The Spine Institute of Louisiana
Shreveport, Louisiana, 71101, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Hospital for Special Surgery (HSS)
New York, New York, 10021, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Mission Hospitals
Asheville, North Carolina, 28801, United States
Dayton Interventional Radiology
Kettering, Ohio, 45409, United States
Edmond Medical Center
Oklahoma City, Oklahoma, 73034, United States
Mercy Health Center
Oklahoma City, Oklahoma, 73120, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Endovascular Center of Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maarten Persenaire, M.D.
Orthovita, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 10, 2006
First Posted
February 13, 2006
Study Start
September 1, 2004
Study Completion
March 1, 2009
Last Updated
October 15, 2008
Record last verified: 2008-10