RecruitingNot ApplicableNCT03439228

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


Sponsor

Hamilton Health Sciences Corporation

Enrollment

50 participants

Start Date

Jul 16, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • Single-level lumbar instrumented postero-lateral fusion from L2-L5
  • Life expectancy greater than 2 years

Exclusion Criteria4

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

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Interventions

DEVICELumbar brace

3 months of lumbar brace wear


Locations(1)

Hamilton General Hospital

Hamilton, Ontario, Canada

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NCT03439228


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