Clinical Trial

To Brace or Not to Brace for Single Level Lumbar Fusion Pilot

Study acronym: BRACE Pilot
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 23, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2018-02-14; most recent amendment 2024-10-21.
Status change: Not Yet Recruiting → Recruiting 2018-08-08
Trial Details
NCT Number NCT03439228
Lead Sponsor Hamilton Health Sciences Corporation
Collaborators: McMaster University, DJO Incorporated, Stryker Canada LP
Conditions Lumbar Spondylosis, Fusion of Spine
Enrollment 50 participants
Start Date 2018-07-16
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-10-23