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

Completed

• Conditions: Sacro-iliac Insufficiency Fractures

• Registration Number: NCT00765258
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2012-05
• Study Completion: 2013-02
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	2008-2012	The average pre-treatment VAS score was significantly improved after sacroplasty in patients with sacral insufficiency fractures.

Trial Locations

Locations (1)

Medical College of Wisconsin / Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States