To Brace or Not to Brace for Single Level Lumbar Fusion Pilot
BRACE Pilot
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedStudy Start
First participant enrolled
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 23, 2024
October 1, 2024
7.4 years
February 14, 2018
October 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of enrolment
Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
12 months
Rate of study completion
Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.
12 months
Secondary Outcomes (3)
Lumbar bone fusion
12 months
Functional Status
3 months, 6 months, 12 months
Pain Status
3 months, 6 months, 12 months
Study Arms (2)
Brace
EXPERIMENTALLumbar brace wear prescribed for 3 months post-operation
No brace
NO INTERVENTIONNo lumbar brace prescribed
Interventions
Eligibility Criteria
You may qualify if:
- Single-level lumbar instrumented postero-lateral fusion from L2-L5
- Life expectancy greater than 2 years
You may not qualify if:
- Previous lumbar surgery
- Spine tumour/cancer
- Documented osteoporosis
- High grade (3 or 4) spondylolisthesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hamilton Health Sciences Corporationlead
- McMaster Universitycollaborator
- DJO Incorporatedcollaborator
- Stryker Canada LPcollaborator
Study Sites (1)
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aleksa Cenic, MSc, MD, FRCSC
Hamilton Health Sciences and McMaster University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2018
First Posted
February 20, 2018
Study Start
July 16, 2018
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
October 23, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share