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CAFE Study - Cancer Patient Fracture Evaluation

2014-07-24 14:27:09 | BioPortfolio

Summary

The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.

Description

1. STUDY OBJECTIVES AND ENDPOINTS

1.1. Objectives

The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer.

1.2. Primary Endpoint

The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment.

1.3. Secondary Endpoints

The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit.

Safety:

- Rate of study treatment-related adverse events

- Change in neurological status

Clinical:

- Change in functional status as assessed with

- the Roland-Morris Disability Questionnaire

- the Karnofsky Performance Scale

- Change in quality of life as assessed by the SF-36v2™ Health Survey

- Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS)

- Change in back-pain analgesics used

- Change in ambulation status

- Changes in activities of daily living

- Time to treatment failure

Radiographic:

- Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory

- Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab

In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.

Study Design

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

Conditions

Cancer

Intervention

Balloon Kyphoplasty, Non Surgical Management

Location

Valley Radiology Inc., UCSD
Escondido
California
United States
92025

Status

Completed

Source

Medtronic Spine LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:27:09-0400

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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.

A surgical specialty concerned with management of cancer.

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

A balloon-assisted enteroscopy utilizing a flexible endoscope with one overtube balloon control unit.

Widening of a stenosed HEART VALVE by the insertion of a balloon CATHETER into the valve and inflation of the balloon.

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