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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03726190
Other study ID # 201801
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date December 31, 2025

Study information

Verified date March 2021
Source Tristate Brain and Spine Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 303
Est. completion date December 31, 2025
Est. primary completion date July 31, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Tristate Brain and Spine Institute Alexandria Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Tristate Brain and Spine Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Surgery Time Skin to skin surgery time measured in minutes During surgery
Secondary Hospital stay The number of nights spent in the hospital following the surgery measured in days Immediately after surgery
Secondary Blood Loss The amount of blood lost during the surgery measured in milliliters. During surgery
Secondary Fluoroscopy Time The time fluoroscopy was used during surgery measured in seconds. During surgery.
Secondary 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
Secondary Infection Rate The percentage of patients that experienced a postoperative surgical site infection. Immediately after surgery
Secondary Bleeding Rate The percentage of patients that experienced bleeding during surgery or immediately after surgery that required transfusion. During surgery and immediately after surgery
Secondary 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
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