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Completed

NCT Number: NCT03155789

Clinical Outcome After Lumbar Fusion

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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Key information

Conditions

Chronic Low Back Pain

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lumbar Fusion

Procedure

Standard Transforaminal Lumbar Interbody Fusion (S TLIF)

Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF)

AxiaLIF Fusion

Primary outcomes

  1. Change from Baseline Visual Analog Scale (VAS)

    Time frame: 2 weeks, 6 months, 1 year

    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. Change from Baseline Prolo Functional and Economic Score

    Time frame: 2 weeks, 6 months, 1 year

    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.

  3. Change from Baseline Dallas Pain Questionnaire (DPQ)

    Time frame: 2 weeks, 6 months, 1 year

    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.

  4. Change from Baseline Short Form 12 (SF-12)

    Time frame: 2 weeks, 6 months, 1 year

    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.

  5. Change from Baseline Oswestry Disability Index (ODI)

    Time frame: 2 weeks, 6 months, 1 year

    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.

Secondary outcomes

  1. Radiologic Fusion Rates

    Time frame: 6 months and 1 year

    Fusion rates will be evaluated by flexion-extension X-rays and CT imaging.

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
May 16, 2017
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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