NCT03439228

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Spondylosis
• Fusion of Spine

Interventions

Type	Name	Description
DEVICE	Lumbar brace	3 months of lumbar brace wear

Timeline

• Start date: 2018-07-16
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2018-02-20
• Last updated: 2024-10-23

Locations

1 site across 1 country: Canada