NCT03439228 To Brace or Not to Brace for Single Level Lumbar Fusion Pilot
| NCT ID | NCT03439228 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hamilton Health Sciences Corporation |
| Condition | Lumbar Spondylosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2018-07-16 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2018-07-16 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Aleksa Cenic, MSc, MD, FRCSC
PRINCIPAL INVESTIGATOR
Hamilton Health Sciences and McMaster University
Frequently Asked Questions
Who can join the NCT03439228 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lumbar Spondylosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03439228 currently recruiting?
Yes, NCT03439228 is actively recruiting participants. Contact the research team at martynia@mcmaster.ca for enrollment information.
Where is the NCT03439228 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT03439228 clinical trial?
NCT03439228 is sponsored by Hamilton Health Sciences Corporation. The principal investigator is Aleksa Cenic, MSc, MD, FRCSC at Hamilton Health Sciences and McMaster University. The trial plans to enroll 50 participants.