Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

This study has been completed.
Sponsor:
Collaborators:
Cardinal
ArthroCare Corporation
Cook
Information provided by (Responsible Party):
Avery Evans, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT00279877
First received: January 18, 2006
Last updated: December 2, 2013
Last verified: December 2013

January 18, 2006
December 2, 2013
May 2005
September 2011   (final data collection date for primary outcome measure)
  • Back specific functional status(Roland) [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Osteoporotic Vertebral Compression Fractures
Procedure: Kyphoplasty
kyphoplasty
  • Active Comparator: vertebroplasty
    vertebroplasty
    Intervention: Procedure: Kyphoplasty
  • Active Comparator: kyphoplasty
    kyphoplasty
    Intervention: Procedure: Kyphoplasty
Not Provided

*   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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00279877
12031
Not Provided
Avery Evans, MD, University of Virginia
University of Virginia
  • Cardinal
  • ArthroCare Corporation
  • Cook
Principal Investigator: Avery Evans, M.D. University of Virginia
University of Virginia
December 2013

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