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Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis

NCT03344484 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-21

No results posted yet for this study

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.

Conditions

  • Spondylolisthesis, Lumbar Region

Interventions

OTHER

Surgical approach

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

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344484 on ClinicalTrials.gov