Actively Recruiting
To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial
Led by Hamilton Health Sciences Corporation · Updated on 2024-10-23
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hamilton Health Sciences Corporation
Lead Sponsor
M
McMaster University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the use of lumbar braces following single-level lumbar fusion surgery for degenerative spondylosis, a non-traumatic spine condition. The study focuses on whether wearing a brace or not leads to better or similar recovery outcomes. There is currently no clear guideline or evidence to support either approach, so this pilot trial collects preliminary data to plan a larger definitive study. Participants will be randomly assigned to one of two groups: those who will wear a lumbar brace for three months after surgery and those who will not wear a brace. The trial will compare the healing of the spine using CT scans one year after surgery and will evaluate patients' pain and functional status at 3, 6, and 12 months post-operation. During the study, participants will be monitored for enrollment and completion rates over 12 months. Researchers will assess lumbar bone fusion through imaging and track changes in pain and functional ability through patient reports at multiple time points. The total study duration involves follow-up for up to one year after surgery to gather comprehensive recovery data.
CONDITIONS
Brief Title
To Brace or Not to Brace for Single Level Lumbar Fusion Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Single-level lumbar instrumented postero-lateral fusion from L2-L5
- Life expectancy greater than 2 years
- Age between 18 and 80 years
You will not qualify if you...
- Previous lumbar surgery
- Spine tumour/cancer
- Documented osteoporosis
- High grade (3 or 4) spondylolisthesis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to discharge
Participants undergo single-level lumbar instrumented postero-lateral fusion surgery followed by immediate recovery care.
1 visit for surgery and hospital stay
Duration - 3 months
Participants in the experimental group wear a lumbar brace for 3 months post-operation; participants in the control group do not wear a brace.
Periodic visits as prescribed for brace management
Duration - Up to 12 months
Participants are assessed for lumbar bone fusion, functional status, and pain status at 3, 6, and 12 months after surgery.
3 visits at 3, 6, and 12 months post-operation
Trial Site Locations
Total: 1 location
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
Research Team
A
Amanda Martyniuk, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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