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Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

NCT03327272 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-11-20

No results posted yet for this study

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.

Conditions

  • Stenosis
  • Herniated Nucleus Pulposus
  • Degenerative Disc Disease
  • Spondylosis
  • Myelopathy
  • Radiculopathy
  • Myeloradiculopathy

Interventions

DRUG

Methylprednisolone

Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure

DRUG

Saline

Administration of saline at surgical site prior to incision closure

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Kern Singh, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2020-07-24
Completion
2020-07-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03327272 on ClinicalTrials.gov