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CAFE Study - Cancer Patient Fracture Evaluation

NCT00211237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2021-01-05

Study results available
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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.

Conditions

Interventions

DEVICE

Balloon Kyphoplasty

Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.

OTHER

Non Surgical Management

Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.

Sponsors & Collaborators

  • Medtronic Spine LLC

    lead INDUSTRY

Principal Investigators

  • James Berenson, M.D. · Institute for Myeloma & Bone Cancer Research

  • Frank Vrionis, M.D. · H. Lee Moffitt Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-04-30
Completion
2009-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • Hungary
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211237 on ClinicalTrials.gov