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To Evaluate Success of Cement Treatment of Spinal Compression Fractures

This study is currently recruiting participants.
Study NCT00166374.   Last updated on September 12, 2005.   Information provided by Mayo Clinic

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Descriptive Information Fields
Brief Title  To Evaluate Success of Cement Treatment of Spinal Compression Fractures
Official Title  Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture
Brief Summary

Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.

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 Phase
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure  pain
disability
Secondary Outcome Measure 
Condition  Back Pain
Intervention  Procedure: balloon kyphoplasty
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  200
Start Date  September 2005
Completion Date
Eligibility Criteria 

vertebral compression fracture

Gender Both
Ages 20 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00166374
Organization ID 1707-05
Secondary IDs ††
Study Sponsor  Mayo Clinic
Collaborators ††
Investigators 
Principal Investigator:     H. Gordon Deen, Jr., M.D.     Mayo Clinic    
Information Provided By Mayo Clinic
Verification Date September 2005
First Received Date  September 12, 2005
Last Updated Date September 12, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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