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

Recruiting now · Not applicable

Conditions studied: Lumbar Spondylosis, Fusion of Spine

In brief

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.

Key facts

Study ID

NCT03439228

Run by

Hamilton Health Sciences Corporation

People needed

50

Starts

2018-07-16

Expected to finish

2025-12-01

Last updated by the study team

2024-10-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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