Comparing two surgical approaches for 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

This study is testing whether a different way of doing back surgery for degenerative lumbar spondylolisthesis can help patients have fewer infections, shorter hospital stays, and save money compared to the traditional method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: Nova Scotia Health Authority (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Halifax, Nova Scotia)
• Trial ID: NCT03344484 on ClinicalTrials.gov

What this trial studies

This pilot study aims to compare the midline and paramedian surgical approaches in patients undergoing fusion procedures for degenerative lumbar spondylolisthesis. It will assess whether the paramedian approach leads to lower infection rates, reduced re-operation rates, shorter hospital stays, and overall cost savings. Eligible patients will be randomized into either the midline or paramedian group, with follow-ups scheduled at 2 weeks, 6 weeks, and 3 months post-surgery. The study will collect baseline patient-reported outcomes and monitor adverse events related to each surgical approach.

Who should consider this trial

Good fit: Ideal candidates are surgical patients with single or two-level degenerative spondylolisthesis who have not responded to conservative care for at least six months.

Not a fit: Patients with a history of osteoporotic fractures, chronic steroid use, previous spinal surgery, or neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced healthcare costs for patients with degenerative lumbar spondylolisthesis.

How similar studies have performed: While there have been observational studies suggesting advantages of the paramedian approach, this pilot study is necessary to provide well-powered, prospective data on the topic.

Eligibility criteria

Inclusion Criteria:

* 1\) surgical candidates with single or two level degenerative spondylolisthesis with the following clinical findings:

  1. a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward
  2. a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing
  3. greater than 6 months of symptoms with failed conservative care
* 2\) sufficiently fluent in English to provide informed consent and complete questionnaires with or without the need of an interpreter.

Exclusion Criteria:

* 1\) clinical history of osteoporotic fracture or chronic oral steroid use;
* 2\) previous posterior lumbar spinal surgery (excluding prior microdiscectomy); and
* 3\) patients who have evidence of neurological disorders that affect physical function (e.g. peripheral neuropathy), neuromuscular disorders (e.g. multiple sclerosis, Parkinson's etc.) or systemic illness (e.g. inflammatory arthritis) that affects physical function

Where this trial is running

Halifax, Nova Scotia

• QEII Health Sciences Centre - Halifax Infirmary site — Halifax, Nova Scotia, Canada (Recruiting)

Study contacts

• Study coordinator: Andrew Glennie, MD

Conditions Spondylolisthesis, Lumbar Region