We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

To Evaluate Success of Cement Treatment of Spinal Compression Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00166374
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : January 20, 2010
Information provided by:

Study Description
Brief Summary:
Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.

Condition or disease Intervention/treatment
Back Pain Procedure: balloon kyphoplasty

Detailed Description:
Patients with vertebral compression fracture will be diagnosed and treated with balloon kyphoplasty. Pain and functional status will be assessed at baseline, 1-, 12-, and 24-months post-operatively using VAS pain scale, Oswestry Disability Index, and SF-36.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. pain
  2. disability

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
vertebral compression fracture
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166374

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: H. Gordon Deen, Jr., M.D. Mayo Clinic
More Information

ClinicalTrials.gov Identifier: NCT00166374     History of Changes
Other Study ID Numbers: 1707-05
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Back Pain
Fractures, Compression
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fractures, Bone
Wounds and Injuries