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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Orthovita d/b/a Stryker.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Orthovita d/b/a Stryker
ClinicalTrials.gov Identifier:
NCT00290862
First received: February 10, 2006
Last updated: October 13, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention
Spinal Fractures
Device: Percutaneous Vertebral Augmentation of compression fractures

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of CORTOSS® Synthetic Cortical Bone Void Filler in Vertebral Augmentation

Resource links provided by NLM:


Further study details as provided by Orthovita d/b/a Stryker:

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) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Maintenance or improvement in function (efficacy prong of primary endpoint) at 24 months compared to pre-treatment baseline using the Oswestry Disability Index (ODI) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Maintenance vertebral height and alignment (efficacy prong of primary endpoint) at 24 Months compared to 1-month post-vertebropalsty baseline radiographs [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • No device-related subsequent surgical intervention at study treated level [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maintenance or improvement in quality of life (secondary endpoint) at 24 months compared to baseline using the SF-12 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Ambulatory status [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Enrollment: 256
Study Start Date: September 2004
Estimated Study Completion Date: March 2009
Arms Assigned Interventions
Experimental: CORTOSS
Patients prospectively randomized to be treated with Cortoss constitute treatment group.
Device: Percutaneous Vertebral Augmentation of compression fractures
Study eligible patients with painful osteoporotic compression fractures will be randomized to percutaneous vertebroplasty with CORTOSS (treatment group) or PMMA (active control group).
Other Names:
  • CORTOSS, a Bis-GMA composite material, a vertebral augmentation strengthening agent.
  • PMMA, commercially available poly methyl methacrylate material, on-label for vertebral augmentation.
Active Comparator: PMMA
Patients prospectively randomized to be treated with PMMA constitute active control group.
Device: Percutaneous Vertebral Augmentation of compression fractures
Study eligible patients with painful osteoporotic compression fractures will be randomized to percutaneous vertebroplasty with CORTOSS (treatment group) or PMMA (active control group).
Other Names:
  • CORTOSS, a Bis-GMA composite material, a vertebral augmentation strengthening agent.
  • PMMA, commercially available poly methyl methacrylate material, on-label for vertebral augmentation.

Detailed Description:

This is a prospective, multi-center randomized, controlled study designed to evaluate the safety and effectiveness of Cortoss® Synthetic Cortical Bone Void Filler in vertebral augmentation using the percutaneous vertebroplasty technique. Study eligible patients with painful osteoporotic compression fractures will be randomized (2:1) to vertebroplasty with Cortoss (treatment group) or PMMA (control group), respectively. Patients will not be told which treatment they will receive (single blind study design). Safety and effectiveness will be determined by comparing the success rate of the treatment group to the success rate of the control group. Secondary endpoints will include Quality of Life, Patient satisfaction, evaluation of the patient's pain and function post-operatively compared to baseline, and maintenance of vertebral body height and alignment.

For the purposes of this study, vertebral augmentation, or vertebroplasty, is defined as a minimally invasive procedure utilizing manual instruments and radiological guidance to deliver an in-situ polymerizable material to stabilize a collapsed or fractured vertebral body. The goal is to alleviate pain caused by the fracture and enhance or prevent further deterioration of function.

This multi-center study will evaluate Cortoss for the augmentation of one or two vertebra(e), fractured as a result of osteoporosis, located between (and including) the levels of the sixth thoracic and the fifth lumbar vertebrae. A total of 243 patients will be enrolled at up to 19 sites. All subjects must have radiographic evidence of a vertebral body fracture due to osteoporosis. After complying with all eligibility criteria, subjects will sign an informed consent document and will be randomized into vertebroplasty treatment with Cortoss or PMMA (1:1 ratio). Patients will be followed for at least 24 months and recruitment is expected to take between 9 and 12 months. Visits and assessments are planned according to the time and events schedule.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290862

Locations
United States, Arizona
Scottsdale Medical Center
Scottsdale, Arizona, United States, 85251
United States, California
Core Orthopaedic Medical Center, P.C.
Encinitas, California, United States, 92024
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
St. John's Spine Institute
Santa Monica, California, United States, 90404
United States, Florida
Indian River Radiology
Vero Beach, Florida, United States, 32960
United States, Georgia
Emory Orthopaedics and Spine Center
Atlanta, Georgia, United States, 30329
United States, Illinois
Millenium Pain Center
Bloomington, Illinois, United States, 61701
Northwestern University
Chicago, Illinois, United States, 60611
United States, Louisiana
The Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
United States, Missouri
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Hospital for Special Surgery (HSS)
New York, New York, United States, 10021
United States, North Carolina
Mission Hospitals
Asheville, North Carolina, United States, 28801
United States, Ohio
Dayton Interventional Radiology
Kettering, Ohio, United States, 45409
United States, Oklahoma
Edmond Medical Center
Oklahoma City, Oklahoma, United States, 73034
Mercy Health Center
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Endovascular Center of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Orthovita d/b/a Stryker
Investigators
Study Director: Maarten Persenaire, M.D. Orthovita, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Maarten Persenaire, M.D., Chief Medical Officer, Orthovita
ClinicalTrials.gov Identifier: NCT00290862     History of Changes
Other Study ID Numbers: 1100-0008
Study First Received: February 10, 2006
Last Updated: October 13, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Orthovita d/b/a Stryker:
Osteoporosis
Spine fracture
Back Pain
Vertebroplasty
Vertebral compression fractures related to osteoporosis

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Compression
Osteoporosis
Spinal Fractures
Back Injuries
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Spinal Injuries
Wounds and Injuries
Polymethyl Methacrylate
Antimutagenic Agents
Cardiovascular Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014