Clinical Outcome After Lumbar Fusion

Study Overview
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Brief Summary
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The main objective of this prospective study is to compare the clinical outcomes after lumbar fusion for chronic low back pain using the four techniques commonly employed in our surgical practice. Lumbar fusion stops motion at a painful vertebral segment, which can decrease back pain. The four techniques are standard transforaminal lumbar interbody fusion (S TLIF), minimally invasive transforaminal lumbar interbody fusion (MI TLIF), extreme lateral interbody fusion (XLIF), and axial lumbar interbody fusion (AxiaLIF). Each differ in where incisions are made and level of invasiveness; not all may be implemented in each surgical case. The four different techniques are all standard approaches with different advantages and have yet to be compared in efficacy for relieving chronic low back pain.

Official Title
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Clinical Outcome After Lumbar Fusion for the Treatment of Chronic Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Procedure: Lumbar Fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe chronic low back pain (at least 7 out of 10 on the VAS scale). Age: 25-65 years. Pain duration at least 2 years. The treating surgeon should interpret the pain as emanating from L4-S1. The patient must have had unsuccessful maximal possible conservative (non surgical) treatment for at least one year. Radiographic evidence (MRI, CT, CT-SPECT, and/or plain films) of degenerative changes (spondylosis) Exclusion Criteria: Psychiatric illness or evidence of emotional instability. Previous spine surgery except for successful removal of a herniated disc more than 2 years before entering the study and with no persistent nerve root symptoms. Specific radiologic findings, such as fractures, infection, inflammatory process, or neoplasm. Obvious painful and disabling arthritic hip joints and anamnestic and radiologic signs of spinal stenosis. Involvement in Workman's Comp or litigation.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Back Pain emanating from L4-5<br>S TLIF at L4-5 (n=10) MI TLIF at L4-5 (n=10) XLIF at L4-5 (n=10) | Procedure: Lumbar Fusion<br>* Standard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion<br>|
| Low Back Pain emanating from L5-S1<br>S TLIF at L5-S1 (n=10) MI TLIF at L5-S1 (n=10) XLIF at L5-S1 (n=10) | Procedure: Lumbar Fusion<br>* Standard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion<br>|
| Low Back Pain emanating from L4-5 and L5-S1<br>S TLIF at L4-5 and L5-S1 (n=10) MI TLIF at L4-5 and L5-S1 (n=10) XLIF at L4-5 and L5-S1 (n=10) | Procedure: Lumbar Fusion<br>* Standard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Visual Analog Scale (VAS) | This is part of the Patient Questionnaire primary outcome measure. A Visual Analogue Scale (VAS) is a measurement instrument that measures the intensity or frequency of pain across a continuum of values. | 2 weeks, 6 months, 1 year | 
| Change from Baseline Prolo Functional and Economic Score | This is part of the Patient Questionnaire primary outcome measure. The Prolo Score is a 10-point scale consisting of only two questions evaluating the functional and economic status of the patient. | 2 weeks, 6 months, 1 year | 
| Change from Baseline Dallas Pain Questionnaire (DPQ) | This is part of the Patient Questionnaire primary outcome measure. The Dallas Pain Questionnaire (DPQ) assess the amount of chronic spine pain that affects the patient's daily and work-leisure activities, anxiety-depression, and social interest. | 2 weeks, 6 months, 1 year | 
| Change from Baseline Short Form 12 (SF-12) | This is part of the Patient Questionnaire primary outcome measure. The Short Form 12 (SF-12) was designed to measure the patient's functional health and well-being. | 2 weeks, 6 months, 1 year | 
| Change from Baseline Oswestry Disability Index (ODI) | This is part of the Patient Questionnaire primary outcome measure. The Oswestry Disability Index measures a patient's impairment and quality of life due to pain. | 2 weeks, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologic Fusion Rates | Fusion rates will be evaluated by flexion-extension X-rays and CT imaging. | 6 months and 1 year |