A Study on the Use of a Brace Following Low Back Surgery

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. Identifier: NCT00620399
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : February 21, 2008
Medtronic Sofamor Danek
Information provided by:
Sunnybrook Health Sciences Centre

Brief Summary:
This study evaluated the hypothesis that bracing following lumbar spinal fusion surgery improves functional outcome following surgery

Condition or disease Intervention/treatment Phase
Lumbar Fusion Other: lumbar corset Phase 3

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Lumbar Fusion With and Without Postoperative Bracing: A Randomized Prospective Study
Study Start Date : May 1996
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Arm Intervention/treatment
Experimental: 1
Other: lumbar corset
Placebo Comparator: 2
no brace
Other: lumbar corset

Primary Outcome Measures :
  1. functional outcome scores [ Time Frame: 2 years following surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-80
  • Undergoing posterior lumbar fusion surgery for degenerative conditions

Exclusion Criteria:

  • Unable to complete questionnaires due to language or cognitive barrier
  • Declined study participation

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 identifier (NCT number): NCT00620399

United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Medtronic Sofamor Danek

Responsible Party: Sanford Emery and Albert Yee, Sunnybrook Health Sciences Centre Identifier: NCT00620399     History of Changes
Other Study ID Numbers: 019511
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: February 2008

Keywords provided by Sunnybrook Health Sciences Centre:
lumbar fusion