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To Evaluate Success of Cement Treatment of Spinal Compression Fractures

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166374
First received: September 12, 2005
Last updated: January 19, 2010
Last verified: January 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Fractures
U.S. FDA Resources

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00166374     History of Changes
Other Study ID Numbers: 1707-05
Study First Received: September 12, 2005
Last Updated: January 19, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013