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To Evaluate Success of Cement Treatment of Spinal Compression Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00166374
First Posted: September 14, 2005
Last Update Posted: January 20, 2010
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.
Information provided by:
Mayo Clinic
  Purpose
Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.

Condition Intervention
Back Pain Procedure: balloon kyphoplasty

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • pain
  • disability

Enrollment: 200
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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 Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: January 20, 2010
Last Verified: January 2010

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