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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Fractures, Compression
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014