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NCT00166374 Clinical Trial

To Evaluate Success of Cement Treatment of Spinal Compression Fractures

Back Pain Clinical Trial

Official title:
Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00166374
Other study ID # 1707-05
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated January 19, 2010
Est. completion date June 2007

Study information
Verified date January 2010
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility vertebral compression fracture

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• balloon kyphoplasty

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain
Primary disability
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