Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion

NCT03726190 | Suspended

• 1 other identifier: 201801
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis; Lumbar Disc Herniation

Keywords

Degenerative Disk Disease; Lumbar Fusion; Minimally Invasive Surgery; Lumbar Disk Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Surgery Time

  During surgery

• Hospital stay

  Immediately after surgery

• Blood Loss

  During surgery

• Fluoroscopy Time

  During surgery.

• Rate of screw fracture

  One year after surgery

Study Arms (1)

OLLIF

Patients who underwent Oblique Lateral Lumbar Interbody Fusion

Procedure: Oblique Lateral Lumbar Fusion

Interventions

Oblique Lateral Lumbar Fusion 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.

OLLIF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tristate Brain and Spine Institute: lead

Study Sites (1)

Tristate Brain and Spine Institute

Alexandria, Minnesota, 56308, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2018
• First Posted: October 31, 2018
• Study Start: January 1, 2013
• Primary Completion: July 31, 2016
• Study Completion: December 31, 2025
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)