Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

Neural injury is a well-known complication following extreme lateral lumbar interbody fusion (XLIF). It has been found that up to 9.4% of patients will have either temporary or persistent neurologic deficit. This occurs with traversal of the psoas muscle or direct injury to lumbosacral plexus or sympathetic ganglion. While often temporary, it can cause hip flexor weakness, thigh numbness, or pain.

Several studies have demonstrated reduced patient reported pain scores following steroid administration, particularly in the early postoperative period. However, few studies have investigated the efficacy of intraoperative local injection of corticosteroid in reducing the incidence and duration of postoperative pain or neurologic injury for XLIF patients.

Study Overview

• Status: Withdrawn
• Conditions: Degenerative Disc Disease; Radiculopathy; Myelopathy; Spondylosis; Stenosis; Herniated Nucleus Pulposus; Myeloradiculopathy
• Intervention / Treatment: Drug: Methylprednisolone; Drug: Saline

Detailed Description

The purpose of this study is to determine if the incidence and duration of postoperative pain is reduced in the subjects receiving a local injection of methylprednisolone when compared to placebo following XLIF.

The investigators hypothesize that subjects undergoing XLIF who receive local methylprednisolone will have:

1. Reduced incidence and duration of postoperative pain and neurologic injury
2. Shorter hospital stay
3. Better short- and long-term outcomes

The study also aims to answer the following questions:

1. Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo?
2. Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo?
3. Is local corticosteroid therapy associated with improved short and long-term outcomes?

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing a 1- to 2-level XLIF
• Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
• Patients able to provide informed consent

Exclusion Criteria:

• Allergies or other contraindications to medicines in the protocol including:
• Existing history of gastrointestinal bleeding
• Lumbar spine trauma
• Unable to speak, read, or understand English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local injection of methylprednisolone; Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure	Drug: Methylprednisolone; Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure; Other Names: Depomedrol
Placebo Comparator: Local injection of saline; Administration of saline at surgical site prior to incision closure.	Drug: Saline; Administration of saline at surgical site prior to incision closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Change in Visual Analogue Scale (VAS) Back and Leg pain score from preoperative value will be assessed. VAS back and leg pain scores assess pain in each region on a scale from 0-10 with 0 being no pain and 10 being worst pain imaginable.	2 year postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Functioning	Patient-Reported Outcomes Measurement Information System (PROMIS) physical function score as compared to preoperative value. This score assesses physical function and is scaled from 0-100 with 100 indicating greater functioning and 0 indicating worse functioning.	2 year postoperative
Disability	Oswestry Disability Index (ODI) score as compared to preoperative score. ODI assesses disability out of a total of 50 points and is scaled to a percentage of total possible points with 0 indicating no disability and 100 indicating severe disability.	2 year postoperative
General health status	Short Form (SF)-12 Survey scores as compared to preoperative values. SF-12 assesses general physical and mental health on a scale of 0 to 100 with higher scores indicating superior health status	2 year postoperative
Narcotic Consumption	The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents	2 year postoperative
Length of Stay	The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria	1 week postoperative
Post-operative adverse events	Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU	1 week postoperative

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): July 24, 2020
• Study Completion (Actual): July 24, 2020

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Radiculopathy; Spinal Cord Diseases; Spondylosis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 17102301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No