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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: August 17, 2016
Last verified: August 2016
  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 Blind (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

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
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: NCT00279877

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Cardinal
ArthroCare Corporation
Cook
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
Study First Received: January 18, 2006
Last Updated: August 17, 2016

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

ClinicalTrials.gov processed this record on June 22, 2017