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Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion

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ClinicalTrials.gov Identifier: NCT03726190
Recruitment Status : Active, not recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Tristate Brain and Spine Institute

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.

Condition or disease Intervention/treatment
Degenerative Disc Disease Spondylolisthesis Lumbar Disc Herniation Procedure: Oblique Lateral Lumbar Fusion

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Study Type : Observational
Actual Enrollment : 303 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : July 31, 2016
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Patient reported disability on the Oswestry Disability Index [ Time Frame: One year after surgery ]
    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.

  2. Fusion rate [ Time Frame: One year after surgery ]
    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.

  3. Rate of Neuropraxia [ Time Frame: One year after surgery ]
    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.

  4. Rate of Nerve Root Irritation [ Time Frame: One year after surgery ]
    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.


Secondary Outcome Measures :
  1. Surgery Time [ Time Frame: During surgery ]
    Skin to skin surgery time measured in minutes

  2. Hospital stay [ Time Frame: Immediately after surgery ]
    The number of nights spent in the hospital following the surgery measured in days

  3. Blood Loss [ Time Frame: During surgery ]
    The amount of blood lost during the surgery measured in milliliters.

  4. Fluoroscopy Time [ Time Frame: During surgery. ]
    The time fluoroscopy was used during surgery measured in seconds.

  5. Rate of screw fracture [ Time Frame: One year after surgery ]
    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.

  6. Infection Rate [ Time Frame: Immediately after surgery ]
    The percentage of patients that experienced a postoperative surgical site infection.

  7. Bleeding Rate [ Time Frame: During surgery and immediately after surgery ]
    The percentage of patients that experienced bleeding during surgery or immediately after surgery that required transfusion.

  8. Patient reported pain on a 10-point pain scale [ Time Frame: One year after surgery ]
    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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726190


Locations
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United States, Minnesota
Tristate Brain and Spine Institute
Alexandria, Minnesota, United States, 56308
Sponsors and Collaborators
Tristate Brain and Spine Institute

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Responsible Party: Tristate Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT03726190     History of Changes
Other Study ID Numbers: 201801
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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

Keywords provided by Tristate Brain and Spine Institute:
Degenerative Disk Disease
Lumbar Fusion
Minimally Invasive Surgery
Lumbar Disk Disease

Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis