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

Study acronym: BRACE Pilot
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2025 → Dec 2027
See other at-risk trials from Hamilton Health Sciences Corporation

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 2025 to Dec 2027
    • Eligibility criteria expanded, about 6 words
  2. Primary and study completion dates: Apr 30, 2025 to Dec 2025v7
  3. Primary and study completion dates: Apr 30, 2023 to Apr 30, 2025v6
  4. Primary and study completion dates: Apr 30, 2021 to Apr 30, 2023v5
  5. Primary and study completion dates: Apr 30, 2020 to Apr 30, 2021v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 16, 2018 to Jul 16, 2018
    • Study sites: 0 to 1
    • Collaborators: 2 to 3
    v3
  2. Start date: Mar 1, 2018 to Apr 16, 2018
    • Primary endpoints: 1 to 2
    • Primary and study completion dates: Mar 31, 2020 to Apr 30, 2020
    • Secondary endpoints: details revised at 1 of 3 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03439228
Lead Sponsor Hamilton Health Sciences Corporation
Collaborators: McMaster University, DJO Incorporated, Stryker Canada LP
Conditions
(from sponsor)		 Lumbar Spondylosis, Fusion of Spine
Related terms Spondylosis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov