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Lumbar Brace for Lumbar Spondylosis (BRACE Pilot Trial)

N/A

Recruiting

Led By Aleksa Cenic, MSc, MD, FRCSC

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Single-level lumbar instrumented postero-lateral fusion from L2-L5

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 12 months

Awards & highlights

BRACE Pilot Trial Summary

This trial is examining whether it is better to prescribe a lumbar brace or not following single-level lumbar fusion for degenerative spondylosis. Outcomes will be compared using CT scans and patient reports of pain and function.

Who is the study for?

This trial is for individuals with a life expectancy over 2 years who are undergoing single-level lumbar fusion surgery between the L2-L5 vertebrae due to non-traumatic spondylosis. It's not suitable for those with previous lumbar surgeries, spine tumors/cancer, osteoporosis, or high-grade spondylolisthesis.Check my eligibility

What is being tested?

The study is testing whether wearing a lumbar brace after single-level lumbar fusion surgery affects bone healing and recovery. Patients will be monitored through CT scans one year post-surgery and their pain and functional scores will be compared.See study design

What are the potential side effects?

While the trial itself does not involve medication that would cause side effects, wearing a brace could potentially lead to discomfort, skin irritation, or restricted movement during the recovery period.

BRACE Pilot Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a specific spine surgery involving screws and rods between L2 and L5.

BRACE Pilot Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of enrolment

Rate of study completion

Secondary outcome measures

Functional Status

Lumbar bone fusion

Pain Status

BRACE Pilot Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BraceExperimental Treatment1 Intervention

Lumbar brace wear prescribed for 3 months post-operation

Group II: No braceActive Control1 Intervention

No lumbar brace prescribed

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,951 Total Patients Enrolled

McMaster UniversityOTHER

881 Previous Clinical Trials

2,597,836 Total Patients Enrolled

DJO IncorporatedIndustry Sponsor

15 Previous Clinical Trials

1,234 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What specific criteria must a participant fulfill to be eligible for this experiment?

"For potential enrolment into this experiment, applicants must have a spinal fusion affliction and be between 18 to 80 years old. To date, roughly 50 individuals are being sought after for the trial."

Answered by AI

Are there still opportunities for participation in this clinical trial?

"Clinicaltrials.gov attests that this research initiative is actively looking for participants, with the original posting date being July 16th 2018 and most recent update taking place March 21st 2022."

Answered by AI

Is the eligibility for this experiment restricted to adults above 18?

"Eligibility for this medical trial requires individuals to be within the age bracket of 18 and 80 years. Additionally, there are two separate trials dedicated to minors under 18, as well as 24 studies targeting those above 65."

Answered by AI

How many participants are being monitored as part of this research endeavor?

"Affirmative. According to records on clinicaltrials.gov, this study is currently recruiting members. It was initially unveiled on July 16th 2018 and underwent its last revision on March 21st 2022. 50 participants need to be recruited from a single medical facility for the trial's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "To Brace or Not to Brace for Single Level Lumbar Fusion Pilot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03439228.