Lumbar SpondylosisBRACE PilotNCT03439228
To Brace or Not to Brace for Single Level Lumbar Fusion Pilot
A study testing Lumbar brace in people with Lumbar Spondylosis and Fusion of Spine, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Spondylosis, Fusion of Spine
- What is being tested?
- Lumbar brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2018to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single-level lumbar instrumented postero-lateral fusion from L2-L5
- Life expectancy greater than 2 years
Who cannot join
- Previous lumbar surgery
- Spine tumour/cancer
- Documented osteoporosis
- High grade (3 or 4) spondylolisthesis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Amanda Martyniuk, MSc
About this study
Official title: To Brace or Not to Brace for Single Level Lumbar Fusion: A Pilot Prospective Randomized Controlled Trial
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.
- Conditions
- Lumbar Spondylosis, Fusion of Spine
- Being tested
- Lumbar brace
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar braceDevice
3 months of lumbar brace wear
| Study group | Role | What they receive |
|---|---|---|
| Brace | Experimental | Lumbar brace wear prescribed for 3 months post-operation Receives: Device: Lumbar brace |
| No brace | No intervention | No lumbar brace prescribed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of enrolment
Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
Measured: 12 months
Rate of study completion
Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.
Measured: 12 months
Secondary outcomes (3)
Lumbar bone fusion
Status of bone fusion assessed radiologically by CT scan
Measured: 12 months
Functional Status
The Oswestry Disability Index
Measured: 3 months, 6 months, 12 months
Pain Status
Visual analog scale (0, no pain to 10, worst pain)
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start16 Jul 2018
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, DJO Incorporated, Stryker Canada LP
- Responsible party
- Sponsor
- Investigators
- Aleksa Cenic, MSc, MD, FRCSC, Principal investigator, Hamilton Health Sciences and McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439228
- Sponsor's protocol ID
- 3478
- Acronym
- BRACE Pilot
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2018
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No