To Brace or Not to Brace for Single Level Lumbar Fusion Pilot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lumbar brace.
- Who it may be relevant to
- Registry conditions: Lumbar Spondylosis, Fusion of Spine. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial
Overview
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.
Interventions
- Device Lumbar brace
3 months of lumbar brace wear
Primary outcome measures
- Rate of enrolment [Time frame: 12 months]
- Rate of study completion [Time frame: 12 months]
Secondary outcome measures (3)
- Lumbar bone fusion [Time frame: 12 months]
- Functional Status [Time frame: 3 months, 6 months, 12 months]
- Pain Status [Time frame: 3 months, 6 months, 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Hamilton General Hospital — Hamilton
Identifiers
NCT: NCT03439228 · 3478