Status:
RECRUITING
Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Spondylolisthesis, Lumbar Region
Eligibility:
All Genders
Phase:
NA
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 retrospecti...
Detailed Description
Paramedian lumbar interbody fusion has been hypothesized to be advantageous over midline approaches for several reasons, the most important of which is lower post-operative infection rates. To achieve...
Eligibility Criteria
Inclusion
- 1\) 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
- 2\) sufficiently fluent in English to provide informed consent and complete questionnaires with or without the need of an interpreter.
Exclusion
- 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
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03344484
Start Date
January 30 2018
End Date
December 31 2025
Last Update
August 21 2024
Active Locations (1)
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1
QEII Health Sciences Centre - Halifax Infirmary site
Halifax, Nova Scotia, Canada, B3H3A7