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Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis

Spondylolisthesis, Lumbar Region

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    0 and up

Participation 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

Study Location

QEII Health Sciences Centre - Halifax Infirmary site
QEII Health Sciences Centre - Halifax Infirmary site
Halifax, Nova Scotia
Canada

Contact Study Team

Primary Contact

Orthopaedic Adult Spine Group

[email protected]
902-473-3707
Study Sponsored By
Nova Scotia Health Authority
Participants Required
More Information
Study ID: NCT03344484