To Evaluate Success of Cement Treatment of Spinal Compression Fractures

This study is currently recruiting participants.

Verified by Mayo Clinic, September 2005

First Received: September 12, 2005 No Changes Posted

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

Estimated Enrollment:	200
Study Start Date:	September 2005

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	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Hugh G Deen 904-953-2103
Principal Investigator: Hugh G Deen, MD

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

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

Mayo Clinic

More Information

No publications provided

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

Additional relevant MeSH terms:

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

Disorders of Environmental Origin
Neurologic Manifestations
Pain
Back Pain

ClinicalTrials.gov processed this record on November 27, 2009