Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/31/2018 |
| Start Date: | May 22, 2018 |
| End Date: | December 2020 |
| Contact: | Susan Dvojack, MS |
| Email: | Susan_Dvojack@rush.edu |
| Phone: | 3129426689 |
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.
(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.
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?
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?
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
We found this trial at
1
site
1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-6689
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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