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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):
David F. Kallmes, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00279877
First received: January 18, 2006
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279877

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Cardinal
ArthroCare Corporation
Cook
Investigators
Principal Investigator: David F. Kallmes, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: David F. Kallmes, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00279877     History of Changes
Other Study ID Numbers: 930-05
Study First Received: January 18, 2006
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013