Clinical trial NCT03327272: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Stenosis
Herniated Nucleus Pulposus
Degenerative Disc Disease
Spondylosis
Myelopathy
Radiculopathy
Myeloradiculopathy
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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?

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

Primary outcomes:
measure: Postoperative Pain
timeFrame: 2 year postoperative
Secondary outcomes:
measure: Physical Functioning
timeFrame: 2 year postoperative
measure: Disability
timeFrame: 2 year postoperative
measure: General health status
timeFrame: 2 year postoperative
measure: Narcotic Consumption
timeFrame: 2 year postoperative
measure: Length of Stay
timeFrame: 1 week postoperative
measure: Post-operative adverse events
timeFrame: 1 week postoperative
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Kern Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: