Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT03439228

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

Led by Hamilton Health Sciences Corporation · Updated on 2024-10-23

50

Participants Needed

1

Research Sites

385 weeks

Total Duration

On this page

Sponsors

H

Hamilton Health Sciences Corporation

Lead Sponsor

M

McMaster University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Single-level lumbar instrumented postero-lateral fusion from L2-L5
  • Life expectancy greater than 2 years
Not Eligible

You will not qualify if you...

  • Previous lumbar surgery
  • Spine tumour/cancer
  • Documented osteoporosis
  • High grade (3 or 4) spondylolisthesis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

Actively Recruiting

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Research Team

A

Amanda Martyniuk, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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