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

This study has been completed.
Sponsor:
Collaborator:
Medtronic Sofamor Danek
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00620399
First received: February 11, 2008
Last updated: February 20, 2008
Last verified: February 2008
  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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

Keywords provided by Sunnybrook Health Sciences Centre:
lumbar fusion

ClinicalTrials.gov processed this record on July 22, 2014