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To Evaluate Success of Cement Treatment of Spinal Compression Fractures

This study is currently recruiting participants.
Verified by Mayo Clinic, September 2005

Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00166374
  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

MedlinePlus related topics:   Back Pain    Fractures   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • pain
  • disability

Estimated Enrollment:   200
Study Start Date:   September 2005

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
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

vertebral compression fracture

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166374

Locations
United States, Minnesota
Mayo Clinic     Recruiting
      Rochester, Minnesota, United States, 55905
      Contact: Hugh G Deen     904-953-2103        
      Principal Investigator: Hugh G Deen, MD            

Sponsors and Collaborators
Mayo Clinic

Investigators
Principal Investigator:     H. Gordon Deen, Jr., M.D.     Mayo Clinic    
  More Information

Study ID Numbers:   1707-05
First Received:   September 12, 2005
Last Updated:   September 12, 2005
ClinicalTrials.gov Identifier:   NCT00166374
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Signs and Symptoms
Fractures, Compression
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Neurologic Manifestations
Pain
Back Pain

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2008




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