drugset / Trial / NCT03327272

Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

NCT03327272 ↗

Phase 3 Withdrawn Rush University Medical Center
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2018-05-22
Primary completion
2020-07-24
Completion
2020-07-24

Outcome

Outcome not reported

Stopped (Enrollment): “Did not enroll, PI decided not to proceed.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 80 mg Other