Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis

NCT03344484 | Recruiting

• 1 other identifier: REB1022987
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Infection rate

  infection will be tracked using the Center for Disease Control (CDC) criteria for diagnosing both deep and superficial infections. Deep infections will be diagnosed with deep wound cultures. The CDC criteria for diagnosing superficial infection is erythema, drainage, dehiscence and "surgeon opinion", allowing for significant subjectively in superficial infections.

  6 months

Study Arms (2)

Midline Approach

EXPERIMENTAL

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

Other: Surgical approach

Paramedian Approach

EXPERIMENTAL

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

Other: Surgical approach

Interventions

Surgical approach OTHER

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

Midline Approach; Paramedian Approach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) surgical candidates with single or two level degenerative spondylolisthesis with the following clinical findings:
• a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward
• a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing
• greater than 6 months of symptoms with failed conservative care
• \) sufficiently fluent in English to provide informed consent and complete questionnaires with or without the need of an interpreter.

You may not qualify if:

• \) clinical history of osteoporotic fracture or chronic oral steroid use;
• \) previous posterior lumbar spinal surgery (excluding prior microdiscectomy); and
• \) 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

QEII Health Sciences Centre - Halifax Infirmary site

Halifax, Nova Scotia, B3H3A7, Canada

RECRUITING

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Andrew Glennie, MD

CONTACT

902-473-3707; andrew.glennie@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: January 30, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)