Pathologic Fracture of the Vertebra Due to Osteoporosis Clinical Trial
Official title:
Clinical Evaluation of the Crosstrees® System for PVA in Symptomatic Adult Patients With Acute Vertebral Body Compression Fractures at T4-L5
The clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
Every year in the United States more than 700,000 people suffer from compression fractures
of the spinal column , and the number of people affected is much higher across the world.
Osteoporosis is the main cause of fractures of the vertebral bodies. Other causes of
vertebral fractures include malignant processes including benign lesions (hemangioma) and
malignant lesions (metastatic cancers, myeloma), infections and trauma; however,
osteoporosis is by far the main cause of this problem.
In a normal person, the vertebral bodies are composed of a porous structure called
trabecular or spongy bone encapsulated within a thin external cap of cortical (dense) bone.
In a person with osteoporosis, the trabeculae that form the central porous bone become
thinner and weaker. When this occurs, the vertebral bodies begin to fracture and become
deformed. This deformation of the vertebral bodies is classified into three types, according
to the shape: wedge, biconcave, and crush. The degree of severity of these deformations is
classified as grade A1.1, grade A1.2, or grade A1.3
The Crosstrees PVA™ Pod™ is a device designed to percutaneously provide controlled delivery
of PMMA bone filler material during vertebral augmentation. The Crosstrees PVA System for
Percutaneous Vertebral Augmentation (PVA) is designed for use with Crosstrees Fortibrae
PMMA. The system is novel in providing the ability to control the delivery of PMMA to the
vertebral body without the need for an additional permanent implant to remain within the
patient. The Crosstrees System for Percutaneous Vertebral Augmentation will be used with
Crosstrees Access Tools, which are regulated as Class I exempt orthopedic manual surgical
instruments.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment