Track topics on Twitter Track topics that are important to you
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Percutaneous Vertebral Augmentation of compression fractures
Scottsdale Medical Center
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:46:09-0400
Patients with osteoporotic vertebral body compression fractures will be randomly assigned to treatment with balloon kyphoplasty or vertebroplasty. Over 2 years of follow-up, back pain, ba...
Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentialit...
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral comp...
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with Os...
The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractur...
Network meta-analysis of percutaneous vertebroplasty, percutaneous kyphoplasty, nerve block, and conservative treatment for nonsurgery options of acute/subacute and chronic osteoporotic vertebral compression fractures (OVCFs) in short-term and long-term effects.
Osteoporotic vertebral compression fractures (OVCFs) commonly afflicts most aged people resulting back pain, substantial vertebral deformity, functional disability, decreased quality of life, and incr...
Osteoporotic vertebral compression fractures (OVCFs) are common diseases in elderly patients and can cause serious thoracolumbar compression fractures. For patients with such fractures, conservative t...
Vertebral fractures are associated with persistent pain, disability and mortality. However, around two thirds of women with vertebral fractures are unaware of them. We aimed to analyze which factors c...
Osteoporotic vertebral body fractures (OVFs) represent a significant medical and socioeconomic burden. There is ongoing debate concerning the role of cement augmentation versus conservative management...
This study analyses the difference in 25OH-vitamin D values between two groups of patients both affected by severe osteoporosis with fragility fractures, but one group has vertebral fractures and the ...
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.
Fractures of the short, constricted portion of the thigh bone between the femur head and the trochanters. It excludes intertrochanteric fractures which are HIP FRACTURES.
Procedures to repair or stabilize vertebral fractures, especially compression fractures by injecting BONE CEMENTS into the fractured VERTEBRAE.
Broken bones in the vertebral column.
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...