Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03327272
Status:
WITHDRAWN
Last Update Posted:
2020-11-20
First Post:
2017-10-26
Brief Title:
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not enroll PI decided not to proceed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neural injury is a well-known complication following extreme lateral lumbar interbody fusion XLIF It has been found that up to 94 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None