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RECRUITING
NCT03439228
NA

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

Sponsor: Hamilton Health Sciences Corporation

View on ClinicalTrials.gov

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.

Official title: To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2018-07-16

Completion Date

2025-12

Last Updated

2024-10-23

Healthy Volunteers

No

Interventions

DEVICE

Lumbar brace

3 months of lumbar brace wear

Locations (1)

Hamilton General Hospital

Hamilton, Ontario, Canada