Back to resultsTo Evaluate Success of Cement Treatment of Spinal Compression Fractures
Primary Purpose
Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
balloon kyphoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain
Eligibility Criteria
vertebral compression fracture
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
pain
disability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00166374
Brief Title
To Evaluate Success of Cement Treatment of Spinal Compression Fractures
Official Title
Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
5. Study Description
Brief Summary
Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.
Detailed Description
Patients with vertebral compression fracture will be diagnosed and treated with balloon kyphoplasty. Pain and functional status will be assessed at baseline, 1-, 12-, and 24-months post-operatively using VAS pain scale, Oswestry Disability Index, and SF-36.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
balloon kyphoplasty
Primary Outcome Measure Information:
Title
pain
Title
disability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
vertebral compression fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Gordon Deen, Jr., M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
To Evaluate Success of Cement Treatment of Spinal Compression Fractures
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