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

Sacro-iliac Insufficiency Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765258
• Other study ID #: PRO00008209
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: August 19, 2013
• Start date: January 2008
• Est. completion date: February 2013

Study information

• Verified date: August 2013
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

The purpose of the study is to report the use of CT fluoroscopy guidance during the performance of percutaneous sacroplasty. In addition, clinical results will be reported with the Roland Morris Disability Questionnaire(RMDQ)pre and post procedure, demonstrating the utility of the RMDQ in assessing improvement in patients pain, mobility and ability to perform activities of daily living.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Stress
• Sacro-iliac Insufficiency Fractures

Locations

Country	Name	City	State
United States	Medical College of Wisconsin / Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of pain and improved mobility in patients post percutaneous sacroplasty effectively assessed using the VAS pain scale and RMDQ both pre and post procedure.	The average pre-treatment VAS score was significantly improved after sacroplasty in patients with sacral insufficiency fractures.	2008-2012	Yes