RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Hamilton Health Sciences Corporation • ClinicalTrials.gov ID: NCT03439228

Registry updated: 2026-10-02

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Description

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.

Interventions

Lumbar brace (Device)
3 months of lumbar brace wear

Eligibility criteria

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

Conditions

Lumbar Spondylosis Fusion of Spine

Locations

Hamilton General Hospital — Hamilton, Ontario, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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