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

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.

Study Overview

• Status: Completed
• Conditions: Sacro-iliac Insufficiency Fractures

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 Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin / Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Winthrop University Hospital
• Investigators: Principal Investigator: Sean M Tutton, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): August 21, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress
• Other Study ID Numbers: PRO00008209