RecruitingNot ApplicableNCT03439228

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

To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial


Sponsor

Hamilton Health Sciences Corporation

Enrollment

50 participants

Start Date

Jul 16, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is exploring whether patients who have had a single-level lumbar spinal fusion surgery (a procedure that joins two vertebrae in the lower back together permanently) actually need to wear a back brace afterward. Bracing after spinal fusion is common, but the evidence for its benefit is limited. Wearing a brace can be uncomfortable, restrict movement, and may not be necessary for everyone. This trial will compare outcomes between patients who are braced and those who are not, with the goal of informing future larger studies. The surgery involved (single-level posterolateral lumbar fusion, from L2 to L5) is used to treat conditions like degenerative disc disease, spondylolisthesis, or spinal instability. Participants will be followed up to track their recovery and outcomes. You may be eligible if: - You are between 18 and 80 years old - You are undergoing a single-level lumbar posterolateral fusion between L2 and L5 - Your life expectancy is greater than 2 years You may NOT be eligible if: - You have had previous lumbar surgery - You have a spinal tumor or cancer - You have documented osteoporosis - You have high-grade (grade 3 or 4) spondylolisthesis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICELumbar brace

3 months of lumbar brace wear


Locations(1)

Hamilton General Hospital

Hamilton, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03439228


Related Trials