Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

Study Overview
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Brief Summary
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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.

Official Title
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Minimal Access Midline Lumbar Fusion Versus Traditional Open Posterior Lumbar Interbody Fusion for Degenerative Lumbar Spondylolisthesis

Conditions
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Degenerative Lumbar Spondylolisthesis

Intervention / Treatment
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* Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF)
* Procedure: Posterior lumbar interbody fusion (PLIF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients attending Victoria Hospital Degenerative spondylolisthesis in the lumbar spine at one level Medically Suitable for surgical management Able to consent for surgery Exclusion Criteria: Lytic spondylolisthesis Non degenerative stenosis: tumor, trauma Active infection On long term disability or workers compensation claims Drug or alcohol misuse Lack of permanent home residence Previous surgery in the lumbar spine at the surgical level Previous fusion in the lumbar spine Contraindication to surgery: medical co morbidities Unable to complete questionnaire: eg dementia Unable to give voluntary consent Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: minimally invasive MID-line Lumbar Fusion (MIDLF)<br>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. | Procedure: minimally invasive MID-line Lumbar Fusion (MIDLF)<br> <br> |
| Other: posterior lumbar interbody fusion (PLIF)<br>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. | Procedure: Posterior lumbar interbody fusion (PLIF)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge |  | Length of inhospital stay after surgery - average 4 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |