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

April 16, 2020 updated by: Sunnybrook Health Sciences Centre

Lumbar Fusion With and Without Postoperative Bracing: A Randomized Prospective Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
brace
Other: lumbar corset
Placebo Comparator: 2
no brace
Other: lumbar corset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
functional outcome scores
Time Frame: 2 years following surgery
2 years following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Medtronic Sofamor Danek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1996

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 019511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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