Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

Degenerative Disc Disease Clinical Trial

Official title:

Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03327272
• Other study ID #: 17102301
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 22, 2018
• Est. completion date: July 24, 2020

Study information

• Verified date: November 2020
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 24, 2020
• Est. primary completion date: July 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Herniated Nucleus Pulposus
• Intervertebral Disc Degeneration
• Myelopathy
• Myeloradiculopathy
• Radiculopathy
• Spinal Cord Diseases
• Spondylosis
• Stenosis

Intervention

Drug:
• Methylprednisolone
Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
• Saline
Administration of saline at surgical site prior to incision closure

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of Stay	The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria	1 week postoperative
Secondary	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