ClinicalTrials.gov
ClinicalTrials.gov Menu

Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03344484
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew Glennie, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Spondylolisthesis, Lumbar Region Other: Surgical approach Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study Comparing Midline Versus Paramedian Approaches to the Lumbar Spine for Single- or Two-Level Fusions in Degenerative Spondylolisthesis
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Midline Approach
A midline surgical approach will be used for the exposure required to complete the lumbar fusion.
Other: Surgical approach
Comparison of 2 surgical approaches used to treat degenerative spondylolisthesis via one- and two-level fusion

Experimental: Paramedian Approach
A paramedian (i.e. Wiltse) surgical approach will be used for the exposure required to complete the lumbar fusion.
Other: Surgical approach
Comparison of 2 surgical approaches used to treat degenerative spondylolisthesis via one- and two-level fusion




Primary Outcome Measures :
  1. Infection rate [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Andrew Glennie, Orthopaedic Spine Surgeon, NSHA, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03344484     History of Changes
Other Study ID Numbers: REB1022987
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases