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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03439228

Acronym

BRACE Pilot

Enrollment

Registered

2018-02-20

Start date

2018-07-16

Completion date

2025-12-31

Last updated

2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fusion of Spine, Lumbar Spondylosis

Brief 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.

Interventions

DEVICELumbar brace

3 months of lumbar brace wear

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of enrolment	12 months	Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
Rate of study completion	12 months	Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.

Secondary

Measure	Time frame	Description
Lumbar bone fusion	12 months	Status of bone fusion assessed radiologically by CT scan
Functional Status	3 months, 6 months, 12 months	The Oswestry Disability Index
Pain Status	3 months, 6 months, 12 months	Visual analog scale (0, no pain to 10, worst pain)

Countries

Canada

Contacts

Primary ContactAmanda Martyniuk, MSc

martynia@mcmaster.ca905-521-2100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026