To Brace or Not to Brace for Single Level Lumbar Fusion Pilot (BRACE Pilot)

H

Hamilton Health Sciences (HHS)

Status

Enrolling

Conditions

Lumbar Spondylosis
Fusion of Spine

Treatments

Device: Lumbar brace

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03439228
3478

Details and patient eligibility

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Brace
Experimental group
Description:
Lumbar brace wear prescribed for 3 months post-operation
Treatment:
Device: Lumbar brace
No brace
No Intervention group
Description:
No lumbar brace prescribed

Trial contacts and locations

1

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Central trial contact

Amanda Martyniuk, MSc

Data sourced from clinicaltrials.gov

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