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
|Condition or disease||Intervention/treatment|
|Degenerative Disc Disease Spondylolisthesis Lumbar Disc Herniation||Procedure: Oblique Lateral Lumbar Fusion|
|Study Type :||Observational|
|Actual Enrollment :||303 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- Surgery Time [ Time Frame: During surgery ]Skin to skin surgery time measured in minutes
- Hospital stay [ Time Frame: Immediately after surgery ]The number of nights spent in the hospital following the surgery measured in days
- Blood Loss [ Time Frame: During surgery ]The amount of blood lost during the surgery measured in milliliters.
- Fluoroscopy Time [ Time Frame: During surgery. ]The time fluoroscopy was used during surgery measured in seconds.
- 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.
- Infection Rate [ Time Frame: Immediately after surgery ]The percentage of patients that experienced a postoperative surgical site infection.
- 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.
- 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)
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
|United States, Minnesota|
|Tristate Brain and Spine Institute|
|Alexandria, Minnesota, United States, 56308|