Status:
WITHDRAWN
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Lead Sponsor:
Rush University Medical Center
Conditions:
Stenosis
Herniated Nucleus Pulposus
Eligibility:
All Genders
Phase:
PHASE3
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 d...
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 foll...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03327272
Start Date
May 22 2018
End Date
July 24 2020
Last Update
November 20 2020
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612