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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Brace or Not to Brace for Single Level Lumbar Fusion: A Pilot Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03439228
- Acronym / sponsor ID
- BRACE Pilot / 3478
- Conditions
- Lumbar Spondylosis, Fusion of Spine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University, DJO Incorporated, Stryker Canada LP
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brace | Experimental | Device: Lumbar braceLumbar brace wear prescribed for 3 months post-operation |
| No brace | No intervention | –No lumbar brace prescribed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single-level lumbar instrumented postero-lateral fusion from L2-L5
- Life expectancy greater than 2 years
Key exclusion criteria (4 listed)
- Previous lumbar surgery
- Spine tumour/cancer
- Documented osteoporosis
- High grade (3 or 4) spondylolisthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar brace3 months of lumbar brace wear | Device | Brace |
Primary outcome
Rate of enrolment
Time frame: 12 months
Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
Rate of study completion
Time frame: 12 months
Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aleksa Cenic, MSc, MD, FRCSC principal investigator
Hamilton Health Sciences and McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Martyniuk, MSc (905-521-2100 ext. 44155, martynia@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of enrolment (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.