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

Lumbar Spondylosis Clinical Trial

— BRACE Pilot  

Official title:

To Brace or Not to Brace for Single Level Lumbar Fusion: A Pilot Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03439228
• Other study ID #: 3478
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: September 2023
• Source: Hamilton Health Sciences Corporation
• Contact: Amanda Martyniuk, MSc
• Phone: 905-521-2100
• Email: martynia[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fusion of Spine
• Lumbar Spondylosis
• Spondylosis

Intervention

Device:
• Lumbar brace
3 months of lumbar brace wear

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	DJO Incorporated, McMaster University, Stryker Canada LP

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of enrolment	Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.	12 months
Primary	Rate of study completion	Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.	12 months
Secondary	Lumbar bone fusion	Status of bone fusion assessed radiologically by CT scan	12 months
Secondary	Functional Status	The Oswestry Disability Index	3 months, 6 months, 12 months
Secondary	Pain Status	Visual analog scale (0, no pain to 10, worst pain)	3 months, 6 months, 12 months