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

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

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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