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

2014-08-27 03:46:09 | BioPortfolio

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. 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.

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

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Spinal Fractures

Intervention

Percutaneous Vertebral Augmentation of compression fractures

Location

Scottsdale Medical Center
Scottsdale
Arizona
United States
85251

Status

Active, not recruiting

Source

Orthovita

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:46:09-0400

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Medical and Biotech [MESH] Definitions

Crumbling or smashing of cancellous BONE by forces acting parallel to the long axis of bone. It is applied particularly to vertebral body fractures (SPINAL FRACTURES). (Blauvelt and Nelson, A Manual of Orthopedic Terminology, 1994, p4)

Acute and chronic conditions characterized by external mechanical compression of the SPINAL CORD due to extramedullary neoplasm; EPIDURAL ABSCESS; SPINAL FRACTURES; bony deformities of the vertebral bodies; and other conditions. Clinical manifestations vary with the anatomic site of the lesion and may include localized pain, weakness, sensory loss, incontinence, and impotence.

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Broken bones in the vertebral column.

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