Clinical Outcome After Lumbar Fusion

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Procedure: Lumbar Fusion

• Study Type: Observational
• Enrollment (Actual): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low Back Pain emanating from L4-5; S TLIF at L4-5 (n=10); MI TLIF at L4-5 (n=10); XLIF at L4-5 (n=10)	Procedure: Lumbar Fusion; Standard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion
Low Back Pain emanating from L5-S1; S TLIF at L5-S1 (n=10); MI TLIF at L5-S1 (n=10); XLIF at L5-S1 (n=10)	Procedure: Lumbar Fusion; Standard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion
Low Back Pain emanating from L4-5 and L5-S1; 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; Standard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LSU-7270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No