Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion

NCT ID: NCT03726190

Last Updated: 2021-03-15

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

SUSPENDED

Total Enrollment

303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Disc Disease Spondylolisthesis Lumbar Disc Herniation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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OLLIF

Patients who underwent Oblique Lateral Lumbar Interbody Fusion

Oblique Lateral Lumbar Fusion

Intervention Type PROCEDURE

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.

Interventions

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Oblique Lateral Lumbar Fusion

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tristate Brain and Spine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tristate Brain and Spine Institute

Alexandria, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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201801

Identifier Type: -

Identifier Source: org_study_id

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