To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Rate of study completion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Brace
Lumbar brace wear prescribed for 3 months post-operation
Intervention: Lumbar brace (Device)
No brace
No lumbar brace prescribed
Outcomes
Primary Outcomes
Rate of study completion
Time Frame: 12 months
Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.
Rate of enrolment
Time Frame: 12 months
Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
Secondary Outcomes
- Lumbar bone fusion(12 months)
- Functional Status(3 months, 6 months, 12 months)
- Pain Status(3 months, 6 months, 12 months)