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Clinical Trials/NCT03327272
NCT03327272WithdrawnPhase 3

Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

Rush University Medical Center1 site in 1 countryStarted: May 22, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Withdrawn
Locations
1
Primary Endpoint
Postoperative Pain

Study Overview

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?

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Local injection of methylprednisolone

Active Comparator

Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure

Intervention: Methylprednisolone (Drug)

Local injection of saline

Placebo Comparator

Administration of saline at surgical site prior to incision closure.

Intervention: Saline (Drug)

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: 2 year postoperative

Change in Visual Analogue Scale (VAS) Back and Leg pain score from preoperative value will be assessed. VAS back and leg pain scores assess pain in each region on a scale from 0-10 with 0 being no pain and 10 being worst pain imaginable.

Secondary Outcomes

  • Disability(2 year postoperative)
  • Narcotic Consumption(2 year postoperative)
  • Length of Stay(1 week postoperative)
  • General health status(2 year postoperative)
  • Physical Functioning(2 year postoperative)
  • Post-operative adverse events(1 week postoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kern Singh

Professor, Department of Orthopaedic Surgery

Rush University Medical Center

Study Sites (1)

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