Clinical trial NCT03155789: Clinical Outcome After Lumbar Fusion
Official title: Clinical Outcome After Lumbar Fusion for the Treatment of Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Visual Analog Scale (VAS)
timeFrame: 2 weeks, 6 months, 1 year
measure: Change from Baseline Prolo Functional and Economic Score
timeFrame: 2 weeks, 6 months, 1 year
measure: Change from Baseline Dallas Pain Questionnaire (DPQ)
timeFrame: 2 weeks, 6 months, 1 year
measure: Change from Baseline Short Form 12 (SF-12)
timeFrame: 2 weeks, 6 months, 1 year
measure: Change from Baseline Oswestry Disability Index (ODI)
timeFrame: 2 weeks, 6 months, 1 year
Secondary outcomes:
measure: Radiologic Fusion Rates
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.