To Evaluate Success of Cement Treatment of Spinal Compression Fractures - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 12, 2005

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

pain
disability

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

To Evaluate Success of Cement Treatment of Spinal Compression Fractures

Official Title ^ICMJE

Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Back Pain

Intervention ^ICMJE

Procedure: balloon kyphoplasty

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

vertebral compression fracture

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00166374

Responsible Party

Study ID Numbers ^ICMJE

1707-05

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

H. Gordon Deen, Jr., M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP