Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

This study has been completed.
ArthroCare Corporation
Information provided by (Responsible Party):
Avery Evans, MD, University of Virginia Identifier:
First received: January 18, 2006
Last updated: December 2, 2013
Last verified: December 2013
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Back specific functional status(Roland) [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 12 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health status outcome measure(SF-36) [ Time Frame: 12 mo ] [ Designated as safety issue: No ]

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
Procedure: Kyphoplasty
Active Comparator: kyphoplasty
Procedure: Kyphoplasty


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • > 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
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Please refer to this study by its identifier: NCT00279877

United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
ArthroCare Corporation
Principal Investigator: Avery Evans, M.D. University of Virginia
  More Information

Responsible Party: Avery Evans, MD, MD, University of Virginia Identifier: NCT00279877     History of Changes
Other Study ID Numbers: 12031 
Study First Received: January 18, 2006
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Compression
Fractures, Bone
Wounds and Injuries processed this record on May 26, 2016