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

This study has been completed.

First Received: February 11, 2008 Last Updated: February 20, 2008 History of Changes

Sponsors and Collaborators:	Sunnybrook Health Sciences Centre Medtronic Sofamor Danek
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00620399

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 III

MedlinePlus related topics: Surgery

Study Type:	Interventional
Study Design:	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:

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
1: Experimental brace	Other: lumbar corset
2: Placebo Comparator no brace	Other: lumbar corset

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Sunnybrook Health Sciences Centre ( Sanford Emery and Albert Yee )
Study ID Numbers:	019511
Study First Received:	February 11, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00620399 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sunnybrook Health Sciences Centre:

lumbar fusion

ClinicalTrials.gov processed this record on May 06, 2009