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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620399
First Posted: February 21, 2008
Last Update Posted: February 21, 2008
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:
Medtronic Sofamor Danek
Information provided by:
Sunnybrook Health Sciences Centre
  Purpose
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
brace
Other: lumbar corset
Placebo Comparator: 2
no brace
Other: lumbar corset

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
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): NCT00620399


Locations
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
ClinicalTrials.gov Identifier: NCT00620399     History of Changes
Other Study ID Numbers: 019511
First Submitted: February 11, 2008
First Posted: February 21, 2008
Last Update Posted: February 21, 2008
Last Verified: February 2008

Keywords provided by Sunnybrook Health Sciences Centre:
lumbar fusion