Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment

This study is currently recruiting participants.

Verified by Medical College of Wisconsin, October 2008

Sponsored by:	Medical College of Wisconsin
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00765258

Purpose

To examine, through retrospective and prospective chart review, the difference in pain and mobility, pre and post treatment, as assessed by the patient's completion of the VAS pain scale and Roland Morris Disability Questionnaire (RMDQ).

CT fluoroscopy guidance during percutaneous sacroplasty is an effective treatment for sacro-iliac insufficiency fractures resulting in rapid reduction of pain and improved mobility in patients. This can be effectively assessed using the VAS pain scale and RMDQ both pre and post procedure.

Condition
Pain and Decreased Mobility as a Result of Sacro-Iliac Insufficiency Fractures

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment

Further study details as provided by Medical College of Wisconsin:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient's with pain and decreased mobility as a result of sacro-iliac insufficiency fracture(s).

Criteria

Inclusion Criteria:

greater than 18 years of age and treated with or about to be treated with percutaneous CT fluoro-guided sacroplasty, regardless of gender or ethnicity.

Exclusion Criteria:

less than 18 years old
pregnancy
inability to complete forms and surveys

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765258

Contacts

Contact: Elizabeth Weil

414-805-2077

Locations

United States, Wisconsin
Medical College of Wisconsin / Froedtert Hospital	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Weil eweil@mcw.edu
Principal Investigator: Sean M Tutton, MD

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

Principal Investigator:

Sean M Tutton, MD

Medical College of Wisconsin

More Information

Responsible Party:	Medical College of Wisconsin ( Sean M. Tutton MD )
Study ID Numbers:	PRO00008209
Study First Received:	September 30, 2008
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00765258
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Quality of Life
Disorders of Environmental Origin

Stress
Fractures, Stress
Pain

ClinicalTrials.gov processed this record on January 13, 2009