Recruiting

Midline vs. Paramedian

Sponsor:

Nova Scotia Health Authority

Code:

NCT03344484

Conditions

Spondylolisthesis, Lumbar Region

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Surgical approach

Study Details

Brief 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

Study ID

NCT03344484

Start date

Jan 30, 2018

Status verified date

Aug, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Midline Approach

A midline surgical approach will be used for the exposure required to complete the lumbar fusion.

experimental: Paramedian Approach

A paramedian (i.e. Wiltse) surgical approach will be used for the exposure required to complete the lumbar fusion.

Interventions

Surgical approach

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

Primary outcome measure

  • Infection rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

QEII Health Sciences Centre - Halifax Infirmary site

Recruiting

Halifax, Nova Scotia, Canada, B3H3A7

Contacts

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-21.