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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00765258
First Posted: October 2, 2008
Last Update Posted: August 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Winthrop University Hospital
Information provided by (Responsible Party):
Sean Tutton, MD, Medical College of Wisconsin
  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
Sacro-iliac Insufficiency Fractures

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

Further study details as provided by Sean Tutton, MD, Medical College of Wisconsin:

Primary Outcome Measures:
  • 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. [ Time Frame: 2008-2012 ]
    The average pre-treatment VAS score was significantly improved after sacroplasty in patients with sacral insufficiency fractures.


Enrollment: 14
Study Start Date: January 2008
Study Completion Date: February 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765258


Locations
United States, Wisconsin
Medical College of Wisconsin / Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Winthrop University Hospital
Investigators
Principal Investigator: Sean M Tutton, MD Medical College of Wisconsin
  More Information

Responsible Party: Sean Tutton, MD, Principal Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00765258     History of Changes
Other Study ID Numbers: PRO00008209
First Submitted: September 30, 2008
First Posted: October 2, 2008
Last Update Posted: August 21, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Fractures, Stress
Fractures, Bone
Wounds and Injuries