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
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.
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.
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