Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion

Tristate Brain and Spine Institute303 enrolled

Overview

This study is undertaken to evaluate the outcomes of Oblique Lateral Lumbar Interbody Fusion (OLLIF). Specifically, the study seeks to measure outcomes on radiological imaging, outcomes reported by the patients on standardized questionnaires, and complication rates.

Study Type

OBSERVATIONAL

Enrollment

303

Conditions

Degenerative Disc Disease Spondylolisthesis Lumbar Disc Herniation

Interventions

Oblique Lateral Lumbar FusionPROCEDURE

Oblique lateral lumbar interbody fusion (OLLIF) is a lumbar spinal fusion. OLLIF is performed with the patient in the prone position and employs an oblique lateral approach that enables the instrumentation to pass through Kambin's triangle which is defined as the space between the exiting nerve, the superior border of the caudal vertebra, and the superior articulating process of the inferior facet. This approach may be performed without direct visualization, guided by electrophysiological monitoring and biplanar fluoroscopy. During the approach, a blunt probe is used to make contact with the disc, followed by a series of gentle dilations. Discectomy is performed through a 10-mm access portal. The cage is inserted under continued electrophysiological monitoring and fluoroscopy.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis, confirmed by imaging, of one of the following conditions: severe degenerative disc disease, spondylolisthesis, spinal stenosis, disc herniation * Completion of a full course of conservative therapy. Conservative therapy may include physical therapy, therapeutic injections, bracing and behavioral modification. Exclusion Criteria: * bony obstruction of the approach * significant spinal canal stenosis * large facet hypertrophy * grade II listhesis * scoliosis with Cobb angle \> 10º * Patients who underwent procedures that were converted to open fusions

Locations (1)

Tristate Brain and Spine Institute

Alexandria, Minnesota, United States

Outcomes

Primary Outcomes

Patient reported disability on the Oswestry Disability Index

The Oswestry Disability Index is a commonly used tool to assess disability due to low back pain. The Oswestry is assessed on a standardized questionnaire and the scale ranges from 0% to 100% disability. A lower score is considered less disability.

Time frame: One year after surgery

Fusion rate

The rate of bony fusion as determined by independent radiologists on post-operative CT scans. Radiologists will determine whether each level that was operated on was fused, or not fused.

Time frame: One year after surgery

Rate of Neuropraxia

Neuropraxia is defined as lower extremity weakness of 3/5 or below on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery.

Time frame: One year after surgery

Rate of Nerve Root Irritation

Nerve Root Irritation is defined as lower extremity paresthesias or dysesthesias corresponding to dermatome of the level of surgery or weakness of 4/5 or above on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery.

Time frame: One year after surgery

Secondary Outcomes

Surgery Time

Skin to skin surgery time measured in minutes

Time frame: During surgery

Hospital stay

The number of nights spent in the hospital following the surgery measured in days

Data from ClinicalTrials.gov

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