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Clinical Trials in Canada / NCT03439228
Recruiting Not applicable

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

NCT03439228 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2018-07-16
Last updated
2024-10-23

Condition(s) studied

Lumbar SpondylosisFusion of Spine

Investigational drug(s) / intervention(s)

Lumbar brace

Lumbar brace: 3 months of lumbar brace wear

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Single-level lumbar instrumented postero-lateral fusion from L2-L5 * Life expectancy greater than 2 years Exclusion Criteria: * Previous lumbar surgery * Spine tumour/cancer * Documented osteoporosis * High grade (3 or 4) spondylolisthesis

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hamilton General Hospital Hamilton Ontario Recruiting

More Hamilton Health Sciences Corporation trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03439228 on ClinicalTrials.gov ↗ ← All trials in Canada