Back to resultsCost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial
Primary Purpose
Osteoporotic Vertebral Compression Fractures
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Kyphoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporotic Vertebral Compression Fractures
Eligibility Criteria
> or = 50 years of age Compression fracture (T4-L5)within previous 12 mo. Pain from compression fracture No malignant tumor No back surgery
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
vertebroplasty
kyphoplasty
Arm Description
vertebroplasty
kyphoplasty
Outcomes
Primary Outcome Measures
Back specific functional status(Roland)
Pain
Secondary Outcome Measures
Health status outcome measure(SF-36)
Full Information
NCT ID
NCT00279877
First Posted
January 18, 2006
Last Updated
August 17, 2016
Sponsor
University of Virginia
Collaborators
Cardinal Health, ArthroCare Corporation, Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00279877
Brief Title
Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial
Official Title
Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Cardinal Health, ArthroCare Corporation, Cook Group Incorporated
4. Oversight
5. Study Description
Brief Summary
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Vertebral Compression Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vertebroplasty
Arm Type
Active Comparator
Arm Description
vertebroplasty
Arm Title
kyphoplasty
Arm Type
Active Comparator
Arm Description
kyphoplasty
Intervention Type
Procedure
Intervention Name(s)
Kyphoplasty
Intervention Description
kyphoplasty
Primary Outcome Measure Information:
Title
Back specific functional status(Roland)
Time Frame
12 mo
Title
Pain
Time Frame
12 mo
Secondary Outcome Measure Information:
Title
Health status outcome measure(SF-36)
Time Frame
12 mo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
> or = 50 years of age
Compression fracture (T4-L5)within previous 12 mo.
Pain from compression fracture
No malignant tumor
No back surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avery Evans, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26109687
Citation
Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.
Results Reference
derived
Learn more about this trial
Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial
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