Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion

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 Overview

• Status: Suspended
• Conditions: Lumbar Disc Herniation; Degenerative Disc Disease; Spondylolisthesis
• Intervention / Treatment: Procedure: Oblique Lateral Lumbar Fusion

• Study Type: Observational
• Enrollment (Actual): 303

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Tristate Brain and Spine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who presented to the study center and required lumbar fusion were eligible to participate in this study. The study center draws patients from Minnesota, South Dakota and North Dakota. No demographic restrictions were placed on participation in the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

OLLIF; Patients who underwent Oblique Lateral Lumbar Interbody Fusion

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	One year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery Time	Skin to skin surgery time measured in minutes	During surgery
Hospital stay	The number of nights spent in the hospital following the surgery measured in days	Immediately after surgery
Blood Loss	The amount of blood lost during the surgery measured in milliliters.	During surgery
Fluoroscopy Time	The time fluoroscopy was used during surgery measured in seconds.	During surgery.
Rate of screw fracture	The percentage of all screws placed in the study group that is determined to have fractured on postoperative imaging. Imaging is read by independent radiologists.	One year after surgery
Infection Rate	The percentage of patients that experienced a postoperative surgical site infection.	Immediately after surgery
Bleeding Rate	The percentage of patients that experienced bleeding during surgery or immediately after surgery that required transfusion.	During surgery and immediately after surgery
Patient reported pain on a 10-point pain scale	The level of pain reported by the patient on a standard 10-point pain scale. The scale goes from 0 (no pain) to 10 (worst pain imaginable)	One year after surgery

Collaborators and Investigators

• Sponsor: Tristate Brain and Spine Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): July 31, 2016
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 27, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Minimally Invasive Surgery; Lumbar Disk Disease; Degenerative Disk Disease; Lumbar Fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Spondylolysis; Spondylosis; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: 201801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IDP data will not be made publicly available to preserve the privacy of study participants. Requests to access our data will be considered on a case by case basis to ensure that data cannot be re-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No