Clinical Outcome After Lumbar Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2016-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Lumbar Fusion

Intervention Type PROCEDURE

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)

Lumbar Fusion

Intervention Type 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 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)

Lumbar Fusion

Intervention Type PROCEDURE

Standard Transforaminal Lumbar Interbody Fusion (S TLIF)

Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF)

AxiaLIF Fusion

Interventions

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Lumbar Fusion

Standard Transforaminal Lumbar Interbody Fusion (S TLIF)

Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF)

AxiaLIF Fusion

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No