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Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

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ClinicalTrials.gov Identifier: NCT03327272
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Kern Singh, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE October 26, 2017
First Posted Date  ICMJE October 31, 2017
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE May 22, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2017)
Postoperative Pain [ Time Frame: 2 year postoperative ]
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
Change History Complete list of historical versions of study NCT03327272 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • Physical Functioning [ Time Frame: 2 year postoperative ]
    Patient-Reported Outcomes Measurement Information System (PROMIS) physical function score as compared to preoperative value. This score assesses physical function and is scaled from 0-100 with 100 indicating greater functioning and 0 indicating worse functioning.
  • Disability [ Time Frame: 2 year postoperative ]
    Oswestry Disability Index (ODI) score as compared to preoperative score. ODI assesses disability out of a total of 50 points and is scaled to a percentage of total possible points with 0 indicating no disability and 100 indicating severe disability.
  • General health status [ Time Frame: 2 year postoperative ]
    Short Form (SF)-12 Survey scores as compared to preoperative values. SF-12 assesses general physical and mental health on a scale of 0 to 100 with higher scores indicating superior health status
  • Narcotic Consumption [ Time Frame: 2 year postoperative ]
    The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
  • Length of Stay [ Time Frame: 1 week postoperative ]
    The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria
  • Post-operative adverse events [ Time Frame: 1 week postoperative ]
    Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2017)
  • Physical Functioning [ Time Frame: 2 year postoperative ]
    Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
  • Disability [ Time Frame: 2 year postoperative ]
    Oswestry Disability Index score as compared to preoperative score
  • General health status [ Time Frame: 2 year postoperative ]
    Short Form-12 Survey scores as compared to preoperative value
  • Narcotic Consumption [ Time Frame: 2 year postoperative ]
    The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
  • Length of Stay [ Time Frame: 1 week postoperative ]
    The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria
  • Post-operative adverse events [ Time Frame: 1 week postoperative ]
    Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Official Title  ICMJE Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Stenosis
  • Herniated Nucleus Pulposus
  • Degenerative Disc Disease
  • Spondylosis
  • Myelopathy
  • Radiculopathy
  • Myeloradiculopathy
Intervention  ICMJE
  • Drug: Methylprednisolone
    Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
    Other Name: Depomedrol
  • Drug: Saline
    Administration of saline at surgical site prior to incision closure
Study Arms  ICMJE
  • Active Comparator: Local injection of methylprednisolone
    Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure
    Intervention: Drug: Methylprednisolone
  • Placebo Comparator: Local injection of saline
    Administration of saline at surgical site prior to incision closure.
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2017)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Susan Dvojack, MS 3129426689 Susan_Dvojack@rush.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03327272
Other Study ID Numbers  ICMJE 17102301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kern Singh, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kern Singh, MD Rush University Medical Center
PRS Account Rush University Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP