Cortoss Pivotal Trial
Do you have back pain that
makes it difficult to walk or move freely?
We are conducting a study for the treatment of painful
vertebral compression fractures caused by osteoporosis.
Research study description
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
you have experienced back pain for at least 4 weeks
but not longer than 1 year, you may be eligible to
participate.
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 PMMA (an FDA-approved
bone cement) and the other group of patients will have
the vertebroplasty procedure using a relatively new
(investigational) biomaterial called Cortoss.
Status
Enrolling
Introduction
Each year more than 700,000 women and
men suffer from vertebral compression fractures (spine
fractures) that are often caused by osteoporosis. The
pain can make it difficult to walk or move freely.
Osteoporosis is a fairly common disease, and is especially
common in postmenopausal women. Osteoporosis
causes bones to thin and become more brittle and weak. When
bones in the spine weaken they can break or cave in
under normal pressure. The thinning bones can
collapse during normal activity, leading to a spinal
fracture. These compression fractures can cause
a great deal of pain and can permanently alter the
shape and strength of the spine.
Vertebroplasty is a procedure that has been performed
since 1984. It is minimally invasive and uses
a bone cement to support the vertebra. Vertebroplasty
restores the integrity and strength of the vertebra,
preventing further collapse. Some benefits of
vertebroplasty are almost immediate and can include
significant relief of pain in 70% to 90% of treated
patients, early mobilization, and a return to pre-fracture
activity levels.
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
you have experienced back pain for at least 4 weeks
but not longer than 1 year, you may be eligible to
participate.
Study overview
Patients who qualify for the
study will be placed into one of two groups: (1)
treatment with the investigational bone void filler
(Cortoss) or (2) treatment with PMMA (FDA-approved
bone cement). This is a random selection, like the
flip of a coin.
All enrolled patients will need to be evaluated at
regular follow-up visits. There will be follow-up
visits at 1 week, 1 month, 3, 6, 12, & 24 months. It
is important to know and understand that enrollment
in the study requires that each patient complete all
follow-up visits in a timely manner. This is
an agreement that each patient will make with the physician.
19 sites throughout the United States are participating
in this study, which will include a total of 300 patients. Several
patients have already been enrolled. Patients
will be paid for their time and travel, and reimbursed
for study-related expenses.
Study sponsor
http://www.orthovita.com
Eligibility criteria
To be considered eligible
for this study, candidates must meet the criteria below. Pain and function
questionnaires, physical and neurological exams, and
radiographic imaging studies (CT Scan, X-Ray, MRI or
Bone Scans) will be used to determine if the
candidate meets all study criteria.
- Is at least 18 years of age;
- Is willing and able to give written Informed
Consent to participate in the study and is willing
to comply with protocol requirements;
- Has one or two painful osteoporotic vertebral
compression fracture (from T6 to L5) that requires
the regular use of analgesics or has resulted in
a substantially altered lifestyle due to the pain;
- Has pain that has lasted at least
4 weeks but no longer than 1 year, or has radiographic
images that indicates the fracture is worsening;
- Is appropriately communicative to verbalize and
differentiate with regard to location and intensity
of his/her pain;
Candidates will not be eligible to participate in
this study if any of the following apply:
- Has a vertebral compression fracture caused by
bone tumor or myeloma
- Is currently being treated for cancer or HIV;
- Has a known allergy to acrylics (e.g., methyl
methacrylate);
- Is currently an alcohol, solvent or drug abuser;
- Female patients that are pregnant or nursing,
or of childbearing potential not using a reliable
contraceptive method;
- Is involved in medical litigation;
- Is a prisoner; and
- Have participated in another investigational
study within 30 days prior to inclusion
Participating sites and contact information
If you are interested in learning more about this
study or you know of someone who may be eligible, please
feel free to contact us at 1-(866) 876-9871 or have
their doctor contact us directly.
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