search
Back to results

Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

Primary Purpose

Stenosis, Herniated Nucleus Pulposus, Degenerative Disc Disease

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Methylprednisolone
Saline
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stenosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Local injection of methylprednisolone

Local injection of saline

Arm Description

Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure

Administration of saline at surgical site prior to incision closure.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
Narcotic Consumption
The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
Length of Stay
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria
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

Full Information

First Posted
October 26, 2017
Last Updated
November 18, 2020
Sponsor
Rush University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03327272
Brief Title
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Official Title
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Did not enroll, PI decided not to proceed.
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
July 24, 2020 (Actual)
Study Completion Date
July 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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: Reduced incidence and duration of postoperative pain and neurologic injury Shorter hospital stay Better short- and long-term outcomes The study also aims to answer the following questions: Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo? Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo? Is local corticosteroid therapy associated with improved short and long-term outcomes?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis, Herniated Nucleus Pulposus, Degenerative Disc Disease, Spondylosis, Myelopathy, Radiculopathy, Myeloradiculopathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local injection of methylprednisolone
Arm Type
Active Comparator
Arm Description
Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure
Arm Title
Local injection of saline
Arm Type
Placebo Comparator
Arm Description
Administration of saline at surgical site prior to incision closure.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Depomedrol
Intervention Description
Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Administration of saline at surgical site prior to incision closure
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
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.
Time Frame
2 year postoperative
Secondary Outcome Measure Information:
Title
Physical Functioning
Description
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.
Time Frame
2 year postoperative
Title
Disability
Description
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.
Time Frame
2 year postoperative
Title
General health status
Description
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
Time Frame
2 year postoperative
Title
Narcotic Consumption
Description
The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
Time Frame
2 year postoperative
Title
Length of Stay
Description
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria
Time Frame
1 week postoperative
Title
Post-operative adverse events
Description
Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
Time Frame
1 week postoperative

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kern Singh, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

We'll reach out to this number within 24 hrs