Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
NCT03344484

Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis

Led by Nova Scotia Health Authority · Updated on 2024-08-21

100

Participants Needed

1

Research Sites

413 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Surgical candidates with single or two-level degenerative spondylolisthesis who have:
    1. Back, buttock, and leg pain worsened by walking or standing and improved by lying, sitting, or bending forward
    2. Leg symptoms greater than or equal to back symptoms when walking or standing
    3. Symptoms lasting longer than 6 months despite conservative treatment
  • Sufficient fluency in English to provide informed consent and complete questionnaires, with or without an interpreter
Not Eligible

You will not qualify if you...

  • History of osteoporotic fracture or chronic oral steroid use
  • Previous posterior lumbar spinal surgery (excluding prior microdiscectomy)
  • Evidence of neurological disorders affecting physical function (e.g., peripheral neuropathy), neuromuscular disorders (e.g., multiple sclerosis, Parkinson's disease), or systemic illnesses (e.g., inflammatory arthritis) affecting physical function

AI-Screening

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Trial Site Locations

Total: 1 location

1

QEII Health Sciences Centre - Halifax Infirmary site

Halifax, Nova Scotia, Canada, B3H3A7

Actively Recruiting

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Research Team

A

Andrew Glennie, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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