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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Back Pain emanating from L4-5 |
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| Low Back Pain emanating from L5-S1 |
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| Low Back Pain emanating from L4-5 and L5-S1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Fusion | Procedure | Standard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion |
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| 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 |
| 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 |
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Inclusion Criteria:
Severe chronic low back pain (at least 7 out of 10 on the VAS scale).
Exclusion Criteria:
Psychiatric illness or evidence of emotional instability.
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Each patient who is willing to participate in this study, signs informed consent, and complies with the inclusion/exclusion criteria will be enrolled in the study. Each patient will be enrolled chronologically on a patient enrollment log and given a patient number for the duration of the study.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28698876 | Derived | Serban D, Calina N, Tender G. Standard versus Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Prospective Randomized Study. Biomed Res Int. 2017;2017:7236970. doi: 10.1155/2017/7236970. Epub 2017 Jun 15. |
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