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Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00279877
First Posted: January 20, 2006
Last Update Posted: August 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cardinal
ArthroCare Corporation
Cook Group Incorporated
Information provided by (Responsible Party):
Avery Evans, MD, University of Virginia
  Purpose
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.

Condition Intervention Phase
Osteoporotic Vertebral Compression Fractures Procedure: Kyphoplasty Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial

Further study details as provided by Avery Evans, MD, University of Virginia:

Primary Outcome Measures:
  • Back specific functional status(Roland) [ Time Frame: 12 mo ]
  • Pain [ Time Frame: 12 mo ]

Secondary Outcome Measures:
  • Health status outcome measure(SF-36) [ Time Frame: 12 mo ]

Enrollment: 112
Study Start Date: May 2005
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vertebroplasty
vertebroplasty
Procedure: Kyphoplasty
kyphoplasty
Active Comparator: kyphoplasty
kyphoplasty
Procedure: Kyphoplasty
kyphoplasty

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • > or = 50 years of age
  • Compression fracture (T4-L5)within previous 12 mo.
  • Pain from compression fracture
  • No malignant tumor
  • No back surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279877


Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Cardinal
ArthroCare Corporation
Cook Group Incorporated
Investigators
Principal Investigator: Avery Evans, M.D. University of Virginia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Avery Evans, MD, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT00279877     History of Changes
Other Study ID Numbers: 12031
First Submitted: January 18, 2006
First Posted: January 20, 2006
Last Update Posted: August 18, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Fractures, Compression
Fractures, Bone
Wounds and Injuries