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
  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
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

Resource links provided by NLM:


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
vertebroplasty
Procedure: Kyphoplasty
kyphoplasty
Active Comparator: kyphoplasty
kyphoplasty
Procedure: Kyphoplasty
kyphoplasty

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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

No publications provided

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: December 2, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014