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Back brace or no brace? trial tests recovery after spinal fusion

NCT ID NCT03439228

Symptom relief Sponsor: Hamilton Health Sciences Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 02, 2026 · Last updated Oct 02, 2026

Summary

Surgeons disagree about whether patients should wear a lumbar brace after single-level spinal fusion for degenerative spine disease. This pilot trial randomly assigns 50 adults to wear a brace for three months or to go without one. Researchers compare CT scans of bone healing one year after surgery, along with pain and disability scores, to see whether bracing makes a difference. The study also checks whether a larger trial is practical to run.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a lumbar brace worn for three months after spinal fusion surgery
What this could lead to
If bracing proves unnecessary, patients could avoid the cost and hassle of wearing a brace during recovery. If it helps, surgeons would have clearer guidance on when to prescribe one.
What could go wrong
This is a small pilot study of 50 people, designed mainly to see whether a larger trial is feasible. It cannot settle whether bracing helps or harms, and results may not apply to other types of spinal surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

spondylosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fusion of spine Lumbar spondylosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

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