To Evaluate Success of Cement Treatment of Spinal Compression Fractures

This study has been completed.

First Received on September 12, 2005. Last Updated on January 19, 2010 History of Changes

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00166374

Purpose

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

Condition	Intervention
Back Pain	Procedure: balloon kyphoplasty

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Outcomes Following Balloon Kyphoplasty for Vertebral Compression Fracture

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Fractures

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

pain
disability

Enrollment:	200
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

vertebral compression fracture

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166374

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

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

Mayo Clinic

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00166374 History of Changes
Other Study ID Numbers:	1707-05
Study First Received:	September 12, 2005
Last Updated:	January 19, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Back Pain
Fractures, Compression
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on February 13, 2012