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Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

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ClinicalTrials.gov Identifier: NCT00279877
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : August 18, 2016
ArthroCare Corporation
Cook Group Incorporated
Information provided by (Responsible Party):
Avery Evans, MD, University of Virginia

Brief Summary:
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.

Condition or disease Intervention/treatment Phase
Osteoporotic Vertebral Compression Fractures Procedure: Kyphoplasty Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial
Study Start Date : May 2005
Primary Completion Date : September 2011
Study Completion Date : September 2011

Arm Intervention/treatment
Active Comparator: vertebroplasty
Procedure: Kyphoplasty
Active Comparator: kyphoplasty
Procedure: Kyphoplasty

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

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

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
  • > or = 50 years of age
  • Compression fracture (T4-L5)within previous 12 mo.
  • Pain from compression fracture
  • No malignant tumor
  • No back surgery

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

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

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 Posted: January 20, 2006    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016

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