Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting nerve roots. It is commonly associated with low back and leg pain, and is a frequent reason for spine surgery particularly in individuals over age 65 years. Recently novel minimally invasive surgical techniques have heightened public and government interest by touting benefits of reduced approached-related morbidity which in turn leads to quicker recovery, shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost. However, there is no randomized controlled trial evidence to describe the actual advantages and disadvantages associated with minimally invasive spinal fusion. This pilot study is a randomized control trial comparing minimally invasive MID-line Lumbar Fusion (MIDLF) to traditional "open" posterior lumbar interbody fusion (PLIF) with respect to length of stay, approach related morbidity, patient centered outcome measures, and cost-effectiveness in the treatment of degenerative lumbar spondylolisthesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
London Health Science Centre
London, Ontario, Canada
RECRUITINGLondon Health Sciences Centre
London, Ontario, Canada
RECRUITINGTime to discharge
Time frame: Length of inhospital stay after surgery - average 4 days
Approach-related in-hospital morbidity
Blood loss, length of surgery, narcotic usage, nursing care, and adverse events will be compared between groups
Time frame: At time of index surgery
Oswestry Disability Index
The Oswestry Disability Index is an effective method of measuring disability in patients with back and leg pain and is well suited to patients who have had persistent severe disability. It is commonly utilized, validated and highly reproducible.
Time frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
Cost-effectiveness of the two surgical approaches
Economic score and cost analysis for each procedure
Time frame: Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years
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