Clinical Outcome After Lumbar Fusion

NCT03155789 | Completed

• 1 other identifier: LSU-7270
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Radiologic Fusion Rates

  6 months and 1 year

Study Arms (3)

Low Back Pain emanating from L4-5

1. S TLIF at L4-5 (n=10) 2. MI TLIF at L4-5 (n=10) 3. XLIF at L4-5 (n=10)

Procedure: Lumbar Fusion

Low Back Pain emanating from L5-S1

1. S TLIF at L5-S1 (n=10) 2. MI TLIF at L5-S1 (n=10) 3. XLIF at L5-S1 (n=10)

Procedure: Lumbar Fusion

Low Back Pain emanating from L4-5 and L5-S1

1. S TLIF at L4-5 and L5-S1 (n=10) 2. MI TLIF at L4-5 and L5-S1 (n=10) 3. XLIF at L4-5 and L5-S1 (n=10)

Procedure: Lumbar Fusion

Interventions

Lumbar Fusion PROCEDURE

Standard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion

Low Back Pain emanating from L4-5; Low Back Pain emanating from L4-5 and L5-S1; Low Back Pain emanating from L5-S1

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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")

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 28698876 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 16, 2017
• Study Start: July 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share