RecruitingNot ApplicableNCT03344484

Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis

A Pilot Study Comparing Midline Versus Paramedian Approaches to the Lumbar Spine for Single- or Two-Level Fusions in Degenerative Spondylolisthesis


Sponsor

Nova Scotia Health Authority

Enrollment

100 participants

Start Date

Jan 30, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

For the increasing numbers of patients undergoing fusion procedures for the degenerative lumbar spine, infection and re-operation can negatively impact outcomes. Numerous observational and retrospective reviews have shown advantages to para-median versus midline approaches; however, recent systematic reviews have shown a need for a well-powered, prospective randomized control trials comparing both exposures. As a step towards a long-term goal of an RCT to address this issue, the purpose of this pilot study is to gather initial data to examine whether operative approach impacts the short-term infection rate, re-operation rate, length of stay, and overall costs to the system. Patients deemed appropriate surgical candidates with single or two-level degenerative spondylolisthesis will be approached for participation, and randomized into either the midline or paramedian group. Initial follow-ups will be at 2 and 6 weeks, and 3 months. Infection rates, inpatient and outpatient adverse events, re-operation rates, radiation exposure and costs will be determined. Cost effectiveness analysis will be estimated comparing each procedure using a bottom-up estimation. Post-operative wound infection can have a significant effect on patient short and long term outcomes. If a significant difference in infection rate is demonstrated, as well as lower re-operation rates, shorter stays, and decreased overall costs, adoption of paramedian approaches to single or two-level fusions of the lumbar spine might be suggested, providing fuel for a full-scale RCT.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Surgical approach for people with spondylolisthesis, lumbar region. The study is currently recruiting participants at 1 location.

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.

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Interventions

OTHERSurgical approach

Comparison of 2 surgical approaches used to treat degenerative spondylolisthesis via one- and two-level fusion


Locations(1)

QEII Health Sciences Centre - Halifax Infirmary site

Halifax, Nova Scotia, Canada

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NCT03344484


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