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

This study has been completed.
Medtronic Sofamor Danek
Information provided by:
Sunnybrook Health Sciences Centre Identifier:
First received: February 11, 2008
Last updated: February 20, 2008
Last verified: February 2008
This study evaluated the hypothesis that bracing following lumbar spinal fusion surgery improves functional outcome following surgery

Condition Intervention Phase
Lumbar Fusion
Other: lumbar corset
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Lumbar Fusion With and Without Postoperative Bracing: A Randomized Prospective Study

Further study details as provided by Sunnybrook Health Sciences Centre:

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

Study Start Date: May 1996
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Other: lumbar corset
Placebo Comparator: 2
no brace
Other: lumbar corset


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00620399

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

Responsible Party: Sanford Emery and Albert Yee, Sunnybrook Health Sciences Centre Identifier: NCT00620399     History of Changes
Other Study ID Numbers: 019511
Study First Received: February 11, 2008
Last Updated: February 20, 2008

Keywords provided by Sunnybrook Health Sciences Centre:
lumbar fusion processed this record on May 25, 2017