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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
First Received: September 12, 2005   No Changes Posted
Sponsor: 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

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

Resource links provided by NLM:


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

No publications provided

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

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

ClinicalTrials.gov processed this record on November 27, 2009