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RecruitingNCT03439228BRACE PilotUpdated Oct 2, 2026

To Brace or Not to Brace for Single Level Lumbar Fusion Pilot

An interventional study of Lumbar brace in Lumbar Spondylosis and Fusion of Spine, sponsored by Hamilton Health Sciences Corporation. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2018; still recruiting 8 years 3 months later.
Updated Oct 2, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lumbar Spondylosis
  • Fusion of Spine

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03

In context

Spondylosis

142 studies on the registry are indexed under Spondylosis; 42 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 101 interventional studies indexed under Spondylosis.

Browse Spondylosis studies →

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Single-level lumbar instrumented postero-lateral fusion from L2-L5
  • greater than 2 years

Exclusion criteria

Exclusion Criteria:

  • Previous lumbar surgery
  • Spine tumour/cancer
  • Documented osteoporosis
  • High grade (3 or 4) spondylolisthesis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Brace

    Lumbar brace wear prescribed for 3 months post-operation

    Device: Lumbar brace

  • No intervention
    No brace

    No lumbar brace prescribed

Interventions

  • DeviceLumbar brace

    3 months of lumbar brace wear

06

What researchers measure

Primary outcomes

  1. Rate of enrolment

    Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.

    Time frame: 12 months

  2. Rate of study completion

    Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.

    Time frame: 12 months

Secondary outcomes

  1. Lumbar bone fusion

    Status of bone fusion assessed radiologically by CT scan

    Time frame: 12 months

  2. Functional Status

    The Oswestry Disability Index

    Time frame: 3 months, 6 months, 12 months

  3. Pain Status

    Visual analog scale (0, no pain to 10, worst pain)

    Time frame: 3 months, 6 months, 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Dec 2025→Dec 2027
Oct 2, 2026
Study completion
Dec 2025→Dec 2027
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Primary completion Dec 2025→Dec 2027
    Study completion Dec 2025→Dec 2027
    + 4 other changes: index terms, identifiers, verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03439228
Collaborators
McMaster University, DJO Incorporated, Stryker Canada LP
Responsible party
Sponsor
First posted
Feb 20, 2018
Start date
Jul 16, 2018
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

Amanda Martyniuk, MSc
Contact
martynia@mcmaster.ca
905-521-2100 ext. 44155
Aleksa Cenic, MSc, MD, FRCSC
principal investigator · Hamilton Health Sciences and McMaster University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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