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To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial
The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not. There is a lack of guidelines and evidence to support either treatment option. The purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Hamilton General Hospital
Hamilton, Ontario, Canada
Start Date
July 16, 2018
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2025
Last Updated
October 23, 2024
50
ESTIMATED participants
Lumbar brace
DEVICE
Lead Sponsor
Hamilton Health Sciences Corporation
Collaborators
NCT06528288
NCT05029726
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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