Assessing the use of a lumbar brace after spine fusion surgery
To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial
This study tests if wearing a lumbar brace after spine fusion surgery helps patients recover better than those who don't wear one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hamilton Health Sciences Corporation Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT03439228 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using a lumbar brace following single-level lumbar fusion surgery for degenerative spondylosis. It aims to determine whether patients who wear a brace experience better recovery outcomes compared to those who do not. The study will collect preliminary data on bone healing through CT scans and assess functional and pain scores over a one-year recovery period. The findings will help inform future guidelines on brace usage in post-surgical care.
Who should consider this trial
Good fit: Ideal candidates include individuals undergoing single-level lumbar instrumented postero-lateral fusion from L2-L5 with a life expectancy greater than two years.
Not a fit: Patients with previous lumbar surgery, spine tumors, documented osteoporosis, or high-grade spondylolisthesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence to guide post-operative care and improve recovery outcomes for patients undergoing lumbar fusion surgery.
How similar studies have performed: While there is variability in practice regarding brace use, this study addresses a gap in evidence and aims to provide clarity on the topic, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamilton, Ontario
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Aleksa Cenic, MSc, MD, FRCSC — Hamilton Health Sciences and McMaster University
- Study coordinator: Amanda Martyniuk, MSc
- Email: martynia@mcmaster.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.