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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minimally invasive MID-line Lumbar Fusion (MIDLF) | Other | MIDLF surgery involves a minimally invasive midline laminectomy posterior approach to the lumbar spine. An incision that is smaller than the standard incision is made in the midline of the low back directly over the spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed as described in the PLIF procedure. |
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| posterior lumbar interbody fusion (PLIF) | Other | PLIF surgery involves a standard incision in the midline of the low back directly over the involved spinal levels. Afterward the pressure on the compressed nerves is released, and the disc between the affected vertebrae is completely removed. A metal cage filled with bone graft is placed in between the vertebral bodies where the disc usually lies. This will allow bone fusion (healing) to occur from one vertebral body to the other. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minimally invasive MID-line Lumbar Fusion (MIDLF) | Procedure |
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| Posterior lumbar interbody fusion (PLIF) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge | Length of inhospital stay after surgery - average 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Approach-related in-hospital morbidity | Blood loss, length of surgery, narcotic usage, nursing care, and adverse events will be compared between groups | At time of index surgery |
| Oswestry Disability Index |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale for back pain intensity (0-10; 0=no pain; 10= worst pain) | Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years | |
| Numeric rating scale for leg pain intensity (0-10; o=no pain; 10=worst pain) | Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Urquhart | Contact | 5196858500 | 53062 | jennifer.urquhart@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Chris Bailey | London Health Sciences Centre and Western University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Science Centre | Recruiting | London | Ontario | N6G 5L7 | Canada |
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| Procedure |
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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.
| 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 | Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years |
| General Health outcome measure (SF12) | The SF12 is a standardized health related quality of life outcome questionnaire, which assesses 8 health domains. The physical and mental component can be derived. It has been validated and reliable when applied to the spine patient population | Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years |
| Patient satisfaction | All things considered, how satisfied are you with the results of your recent treatment for your spine condition 1-7. This sentence is the recommended tool for assessing global satisfaction. | Enrollment, 6 weeks, 3 months, 6 months, 1 year, 2 year and 5 years |
| London Health Sciences Centre | Recruiting | London | Ontario | N6G 5L7 | Canada |
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