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Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

This study has been completed.
Sponsor:
Collaborators:
Cardinal
ArthroCare Corporation
Cook Group Incorporated
Information provided by (Responsible Party):
Avery Evans, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT00279877
First received: January 18, 2006
Last updated: August 17, 2016
Last verified: August 2016
January 18, 2006
August 17, 2016
May 2005
September 2011   (Final data collection date for primary outcome measure)
  • Back specific functional status(Roland) [ Time Frame: 12 mo ]
  • Pain [ Time Frame: 12 mo ]
  • Back specific functional status(Roland)
  • Pain
Complete list of historical versions of study NCT00279877 on ClinicalTrials.gov Archive Site
Health status outcome measure(SF-36) [ Time Frame: 12 mo ]
Health status outcome measure(SF-36)
Not Provided
Not Provided
 
Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial
Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Osteoporotic Vertebral Compression Fractures
Procedure: Kyphoplasty
kyphoplasty
  • Active Comparator: vertebroplasty
    vertebroplasty
    Intervention: Procedure: Kyphoplasty
  • Active Comparator: kyphoplasty
    kyphoplasty
    Intervention: Procedure: Kyphoplasty
Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
September 2011
September 2011   (Final data collection date for primary outcome measure)
  • > or = 50 years of age
  • Compression fracture (T4-L5)within previous 12 mo.
  • Pain from compression fracture
  • No malignant tumor
  • No back surgery
Sexes Eligible for Study: All
50 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00279877
12031
Not Provided
Not Provided
Not Provided
Avery Evans, MD, University of Virginia
University of Virginia
  • Cardinal
  • ArthroCare Corporation
  • Cook Group Incorporated
Principal Investigator: Avery Evans, M.D. University of Virginia
University of Virginia
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP