Clinical Outcome After Lumbar Fusion

May 15, 2017 updated by: Gabriel C. Tender, MD, Louisiana State University Health Sciences Center in New Orleans

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Standard Transforaminal Lumbar Interbody Fusion (S TLIF)

Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF)

AxiaLIF 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

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
  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

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 weeks, 6 months, 1 year
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.
2 weeks, 6 months, 1 year
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.
2 weeks, 6 months, 1 year
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.
2 weeks, 6 months, 1 year
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.
2 weeks, 6 months, 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiologic Fusion Rates
Time Frame: 6 months and 1 year
Fusion rates will be evaluated by flexion-extension X-rays and CT imaging.
6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Louisiana State University Health Sciences Center in New Orleans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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