Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion

Degenerative Disc Disease Clinical Trial

Official title:

Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03726190
• Other study ID #: 201801
• Status: Suspended
• 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
• 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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Lumbar Disc Herniation
• Spondylolisthesis

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