Advertisement

Topics

KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures

2014-08-27 03:44:49 | BioPortfolio

Summary

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, back function, quality of life, adverse events, subsequent fractures and cumulative healthcare costs will be compared.

Description

Kyphon Inc. is sponsoring the KAVIAR study, a randomized clinical trial comparing balloon kyphoplasty to vertebroplasty for the treatment of osteoporotic vertebral body compression fractures (VCFs). Up to 1,234 subjects at up to 75 study centers with one to three VCFs and VB morphologies suitable for both balloon kyphoplasty and vertebroplasty will be randomly assigned to receive one or the other procedure. Study visits will occur at baseline, 30 days postoperatively, and at 3, 12 and 24 months postoperatively. At all visits, adverse events, back pain, back function and quality of life will be assessed. In addition, a 7-day phone call will be conducted, which will include assessment of back pain, narcotic use and adverse events. At baseline, pre-discharge, 3-, 12- and 24-month visits, lateral spine x-rays will be taken. The primary endpoint will be the proportion of patients with one or more subsequent fractures at 12 and 24 months, detected radiographically as determined by a core radiology laboratory. Secondary clinical endpoints include changes from baseline in back pain, back function and quality of life, and adverse events. Secondary radiographic comparisons include the restoration and maintenance of VB height and angulation, and sagittal vertical axis, a measure of global sagittal balance. A postoperative CT scan will be evaluated to detect cement extravasation and to examine the relationship between cement distribution and clinical outcomes. Another important feature of the study is a detailed healthcare utilization data assessment. Combined with a costing methodology based on Medicare cost data and other sources, cumulative two-year healthcare costs related to VCF will be estimated. Combined with quality of life measurements, the cost analysis will allow a calculation of the relative cost-effectiveness of balloon kyphoplasty and vertebroplasty. Sample size is based on the primary endpoint, the proportion with subsequent fractures at 24 months.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Spinal Fractures

Intervention

Vertebroplasty, Kyphoplasty, Balloon Kyphoplasty

Location

Scottsdale Medical Imaging, Ltd
Scottsdale
Arizona
United States
85252

Status

Recruiting

Source

Medtronic Spine LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:49-0400

Clinical Trials [1781 Associated Clinical Trials listed on BioPortfolio]

A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases

Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compr...

Comparative Study of Balloon Kyphoplasty and Conservative Treatment

This study will compare two treatments in acute stable traumatic vertebral fractures (types A1, A2 and A3.1 in MAGERL Classification). The two treatments are the followings: 1. Conserv...

Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures

This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.

Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.

Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the ...

Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation

Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two s...

PubMed Articles [2784 Associated PubMed Articles listed on BioPortfolio]

Comparison of percutaneous balloon dilation kyphoplasty and percutaneous vertebroplasty in treatment for thoracolumbar vertebral compression fractures.

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...

Delayed Height Loss after Kyphoplasty in Osteoporotic Vertebral Fracture with Severe Collapse: Comparison with Vertebroplasty.

To compare clinical and radiographic outcomes, as well as complications after vertebroplasty (VP) and kyphoplasty (KP) for osteoporotic vertebral fractures (OVFs) with severe collapse.

Cost-Effectiveness of Balloon Kyphoplasty for Patients with Acute/ Subacute Osteoporotic Vertebral Fractures in the Super-Aging Japanese Society.

Propensity score matching study OBJECTIVE.: To assess the cost effectiveness of balloon kyphoplasty (BKP) in Japan.

Comparison of Percutaneous Kyphoplasty versus Modified Percutaneous Kyphoplasty for Treatment of Osteoporotic Vertebral Compression Fractures.

Although percutaneous kyphoplasty (PKP) is performed to restore the vertebral body height and kyphosis in osteoporotic vertebral compression fractures (OVCFs), the regained height may be lost upon bal...

Projection of the Most Anterior Line of the Spinal Canal on Lateral Radiograph: An Anatomic Study for Percutaneous Kyphoplasty and Percutaneous Vertebroplasty.

To measure the projection of the most anterior line of the spinal canal on lateral radiographs of the vertebra (C3-L5) and evaluate the efficacy of the safety line (SL) in preventing intraspinal cemen...

Medical and Biotech [MESH] Definitions

Procedures to restore vertebrae to their original shape following vertebral compression fractures by inflating a balloon inserted into the vertebrae, followed by removal of the balloon and injection of BONE CEMENTS to fill the cavity.

Procedures to repair or stabilize vertebral fractures, especially compression fractures by injecting BONE CEMENTS into the fractured VERTEBRAE.

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)

The use of balloon CATHETERS to remove emboli by retraction of the balloon that is inflated behind the EMBOLUS.

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.

More From BioPortfolio on "KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pain
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...

Healthcare
Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial