Spinal FracturesNCT00290862
A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis
A study testing Percutaneous Vertebral Augmentation of compression fractures in people with Spinal Fractures, run by Orthovita d/b/a Stryker at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- Percutaneous Vertebral Augmentation of compression fractures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 18 sitesUnited States
- Study dates
- Sep 2004to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Mission Hospitals
Asheville, North Carolina, 28801
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
Millenium Pain Center
Bloomington, Illinois, 61701
Northwestern University
Chicago, Illinois, 60611
Core Orthopaedic Medical Center, P.C.
Encinitas, California, 92024
Endovascular Center of Houston
Houston, Texas, 77030
Dayton Interventional Radiology
Kettering, Ohio, 45409
Hospital for Special Surgery (HSS)
New York, New York, 10021
Edmond Medical Center
Oklahoma City, Oklahoma, 73034
Mercy Health Center
Oklahoma City, Oklahoma, 73120
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Eisenhower Medical Center
Rancho Mirage, California, 92270
St. John's Spine Institute
Santa Monica, California, 90404
Scottsdale Medical Center
Scottsdale, Arizona, 85251
The Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Washington University Medical Center
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
Indian River Radiology
Vero Beach, Florida, 32960
About this study
Official title: A Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of CORTOSS® Synthetic Cortical Bone Void Filler in Vertebral Augmentation
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.
Read the 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.
- Conditions
- Spinal Fractures
- Being tested
- Percutaneous Vertebral Augmentation of compression fractures
- Keywords
- Osteoporosis, Spine fracture, Back Pain, Vertebroplasty, Vertebral compression fractures related to osteoporosis
- Medical subject headings
- Spinal Fractures, Osteoporosis, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Vertebral Augmentation of compression fracturesDevice
Also called CORTOSS, a Bis-GMA composite material, a vertebral augmentation strengthening agent., PMMA, commercially available poly methyl methacrylate material, on-label for vertebral augmentation.
Study eligible patients with painful osteoporotic compression fractures will be randomized to percutaneous vertebroplasty with CORTOSS (treatment group) or PMMA (active control group).
| Study group | Role | What they receive |
|---|---|---|
| CORTOSS | Experimental | Patients prospectively randomized to be treated with Cortoss constitute treatment group. Receives: Device: Percutaneous Vertebral Augmentation of compression fractures |
| PMMA | Active comparator | Patients prospectively randomized to be treated with PMMA constitute active control group. Receives: Device: Percutaneous Vertebral Augmentation of compression fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 24 Months
Maintenance vertebral height and alignment (efficacy prong of primary endpoint) at 24 Months compared to 1-month post-vertebropalsty baseline radiographs
Measured: 24 Months
No device-related subsequent surgical intervention at study treated level
Measured: 24 Months
Secondary outcomes (3)
Maintenance or improvement in quality of life (secondary endpoint) at 24 months compared to baseline using the SF-12
Measured: 24 Months
Ambulatory status
Measured: 24 Months
Patient satisfaction
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startSep 2004
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthovita d/b/a Stryker
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maarten Persenaire, M.D., Study director, Orthovita, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290862
- Sponsor's protocol ID
- 1100-0008
- Status last verified
- Oct 2008
- First submitted
- 10 Feb 2006
- Last updated
- 15 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of CORTOSS® Synthetic Cortical Bone Void Filler in Vertebral Augmentation
- ClinicalTrials.gov ID
- NCT00290862
- Acronym / sponsor ID
- 1100-0008
- Conditions
- Spinal Fractures
- Keywords
- Osteoporosis, Spine fracture, Back Pain, Vertebroplasty, Vertebral compression fractures related to osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Orthovita d/b/a StrykerIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Mar 2009
- First posted
- 13 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORTOSS | Experimental | Device: Percutaneous Vertebral Augmentation of compression fracturesPatients prospectively randomized to be treated with Cortoss constitute treatment group. |
| PMMA | Active comparator | Device: Percutaneous Vertebral Augmentation of compression fracturesPatients prospectively randomized to be treated with PMMA constitute active control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Vertebral Augmentation of compression fracturesAlso: CORTOSS, a Bis-GMA composite material, a vertebral augmentation strengthening agent., PMMA, commercially available poly methyl methacrylate material, on-label for vertebral augmentation.Study eligible patients with painful osteoporotic compression fractures will be randomized to percutaneous vertebroplasty with CORTOSS (treatment group) or PMMA (active control group). | Device | CORTOSS, PMMA |
Primary outcome
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
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
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
No device-related subsequent surgical intervention at study treated level
Time frame: 24 Months
3 secondary outcomes
Maintenance or improvement in quality of life (secondary endpoint) at 24 months compared to baseline using the SF-12
Time frame: 24 Months
Ambulatory status
Time frame: 24 Months
Patient satisfaction
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Persenaire, M.D. study director
Orthovita, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Vertebral Augmentation of compression fractures in people with Spinal Fractures, run by Orthovita d/b/a Stryker at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.