Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion

Suspended

• Conditions: Spondylolisthesis; Degenerative Disc Disease; Lumbar Disc Herniation
• Interventions: Procedure: Oblique Lateral Lumbar Fusion

• Registration Number: NCT03726190
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2016-07-31
• Study First Submitted: 2018-10-27
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 303

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OLLIF	Oblique Lateral Lumbar Fusion	Patients who underwent Oblique Lateral Lumbar Interbody Fusion

Primary Outcome Measures

Name	Time	Method
Fusion rate	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 Nerve Root Irritation	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.
Patient reported disability on the Oswestry Disability Index	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.
Rate of Neuropraxia	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.

Secondary Outcome Measures

Name	Time	Method
Hospital stay	Immediately after surgery	The number of nights spent in the hospital following the surgery measured in days
Blood Loss	During surgery	The amount of blood lost during the surgery measured in milliliters.
Fluoroscopy Time	During surgery.	The time fluoroscopy was used during surgery measured in seconds.
Infection Rate	Immediately after surgery	The percentage of patients that experienced a postoperative surgical site infection.
Patient reported pain on a 10-point pain scale	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)
Rate of screw fracture	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.
Surgery Time	During surgery	Skin to skin surgery time measured in minutes
Bleeding Rate	During surgery and immediately after surgery	The percentage of patients that experienced bleeding during surgery or immediately after surgery that required transfusion.

Trial Locations

Locations (1)

Tristate Brain and Spine Institute; 🇺🇸 Alexandria, Minnesota, United States