<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03308084</url>
  </required_header>
  <id_info>
    <org_study_id>15052003</org_study_id>
    <nct_id>NCT03308084</nct_id>
  </id_info>
  <brief_title>Use of Local Intraoperative Steroid in MIS TLIF</brief_title>
  <official_title>Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the frequency and duration of postoperative pain&#xD;
      are improved in participants receiving a local steroid injection (methylprednisolone) plus a&#xD;
      systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving&#xD;
      a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already&#xD;
      currently used at Rush and are considered standard of practice. It is well established that&#xD;
      steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is&#xD;
      routinely used in many types of surgery, but it is not known whether two steroids are better&#xD;
      than one. The medications provided in this study are approved by the Food and Drug&#xD;
      Administration (FDA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain is a well-known complication following minimally invasive transforaminal&#xD;
      lumbar interbody fusion (MIS TLIF). It has been found that up to 40% of lumbar spinal&#xD;
      patients will have either recurrent or persistent postoperative pain. Several studies have&#xD;
      demonstrated reduced patient reported pain scores following steroid administration. However,&#xD;
      few studies have investigated intraoperative local injection of corticosteroid at the&#xD;
      surgical site in an effort to reduce the incidence and duration of postoperative pain for MIS&#xD;
      TLIF patients.&#xD;
&#xD;
      The purpose of this study is to determine if the incidence and duration of postoperative pain&#xD;
      is improved in participants receiving a local injection of methylprednisolone with systemic&#xD;
      dexamethasone when compared to those receiving the usual systemic dexamethasone undergoing&#xD;
      MIS TLIF.&#xD;
&#xD;
      The investigators hypothesize that participants undergoing MIS TLIF who receive local&#xD;
      methylprednisolone along with the systemic dexamethasone will have:&#xD;
&#xD;
        1. Reduced incidence and duration of postoperative pain compared to participants receiving&#xD;
           only systemic dexamethasone.&#xD;
&#xD;
        2. Shorter hospital stay compared to participants receiving only systemic dexamethasone.&#xD;
&#xD;
        3. Better short- and long-term outcomes compared to participants receiving only systemic&#xD;
           dexamethasone&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2015</start_date>
  <completion_date type="Actual">May 3, 2019</completion_date>
  <primary_completion_date type="Actual">May 3, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Functioning</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System score as compared to preoperative value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Oswestry Disability Index score as compared to preoperative score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General health status</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Short Form-12 Survey scores as compared to preoperative value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Narcotic Consumption</measure>
    <time_frame>1 week postoperative</time_frame>
    <description>The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>1 week postoperative</time_frame>
    <description>The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-operative adverse events</measure>
    <time_frame>day of surgery</time_frame>
    <description>Blood loss, length of surgery, procedural details, complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative adverse events</measure>
    <time_frame>1 week postoperative</time_frame>
    <description>Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Dysphasia</condition>
  <arm_group>
    <arm_group_label>Local Depomedrol plus IV dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV dexamethasone</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard systemic (IV) dexamethasone only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure</description>
    <arm_group_label>Local Depomedrol plus IV dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Administration of 10mg Dexamethasone IV intraoperatively</description>
    <arm_group_label>IV dexamethasone</arm_group_label>
    <arm_group_label>Local Depomedrol plus IV dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing a primary 1- to 2-level MIS TLIF&#xD;
&#xD;
          -  Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus&#xD;
             pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal&#xD;
             stenosis&#xD;
&#xD;
          -  Patients able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies or other contraindications to medicines in the protocol including:&#xD;
&#xD;
             (a) Existing history of gastrointestinal bleeding&#xD;
&#xD;
          -  Current Smokers&#xD;
&#xD;
          -  Lumbar spine trauma&#xD;
&#xD;
          -  Bilateral cages&#xD;
&#xD;
          -  Lack of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kern Singh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <reference>
    <citation>Schizas C, Tzinieris N, Tsiridis E, Kosmopoulos V. Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience. Int Orthop. 2009 Dec;33(6):1683-8. doi: 10.1007/s00264-008-0687-8. Epub 2008 Nov 21.</citation>
    <PMID>19023571</PMID>
  </reference>
  <reference>
    <citation>McGirt MJ, Parker SL, Lerner J, Engelhart L, Knight T, Wang MY. Comparative analysis of perioperative surgical site infection after minimally invasive versus open posterior/transforaminal lumbar interbody fusion: analysis of hospital billing and discharge data from 5170 patients. J Neurosurg Spine. 2011 Jun;14(6):771-8. doi: 10.3171/2011.1.SPINE10571. Epub 2011 Mar 18.</citation>
    <PMID>21417699</PMID>
  </reference>
  <reference>
    <citation>Ranguis SC, Li D, Webster AC. Perioperative epidural steroids for lumbar spine surgery in degenerative spinal disease. A review. J Neurosurg Spine. 2010 Dec;13(6):745-57. doi: 10.3171/2010.6.SPINE09796.</citation>
    <PMID>21121754</PMID>
  </reference>
  <reference>
    <citation>Jamjoom BA, Jamjoom AB. Efficacy of intraoperative epidural steroids in lumbar discectomy: a systematic review. BMC Musculoskelet Disord. 2014 May 5;15:146. doi: 10.1186/1471-2474-15-146.</citation>
    <PMID>24885519</PMID>
  </reference>
  <reference>
    <citation>Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6. doi: 10.1097/00024720-200208000-00002.</citation>
    <PMID>12177541</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>Kern Singh</investigator_full_name>
    <investigator_title>Professor, Department of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <keyword>transforaminal lumbar interbody fusion, methylprednisolone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03308084
org study id: 15052003
nct id: NCT03308084
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if the frequency and duration of postoperative pain
      are improved in participants receiving a local steroid injection (methylprednisolone) plus a
      systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving
      a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already
      currently used at Rush and are considered standard of practice. It is well established that
      steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is
      routinely used in many types of surgery, but it is not known whether two steroids are better
      than one. The medications provided in this study are approved by the Food and Drug
      Administration (FDA).
Postoperative pain is a well-known complication following minimally invasive transforaminal
      lumbar interbody fusion (MIS TLIF). It has been found that up to 40% of lumbar spinal
      patients will have either recurrent or persistent postoperative pain. Several studies have
      demonstrated reduced patient reported pain scores following steroid administration. However,
      few studies have investigated intraoperative local injection of corticosteroid at the
      surgical site in an effort to reduce the incidence and duration of postoperative pain for MIS
      TLIF patients.

      The purpose of this study is to determine if the incidence and duration of postoperative pain
      is improved in participants receiving a local injection of methylprednisolone with systemic
      dexamethasone when compared to those receiving the usual systemic dexamethasone undergoing
      MIS TLIF.

      The investigators hypothesize that participants undergoing MIS TLIF who receive local
      methylprednisolone along with the systemic dexamethasone will have:

        1. Reduced incidence and duration of postoperative pain compared to participants receiving
           only systemic dexamethasone.

        2. Shorter hospital stay compared to participants receiving only systemic dexamethasone.

        3. Better short- and long-term outcomes compared to participants receiving only systemic
           dexamethasone
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Postoperative Pain
time frame: 2 years postoperative
description: Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
measure: Physical Functioning
time frame: 2 years postoperative
description: Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
measure: Disability
time frame: 2 years postoperative
description: Oswestry Disability Index score as compared to preoperative score
measure: General health status
time frame: 2 years postoperative
description: Short Form-12 Survey scores as compared to preoperative value
measure: Narcotic Consumption
time frame: 1 week postoperative
description: The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
measure: Length of Stay
time frame: 1 week postoperative
description: The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.
measure: Intra-operative adverse events
time frame: day of surgery
description: Blood loss, length of surgery, procedural details, complications
measure: Post-operative adverse events
time frame: 1 week postoperative
description: Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
arm group label: Local Depomedrol plus IV dexamethasone
arm group type: Active Comparator
description: Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
arm group label: IV dexamethasone
arm group type: Placebo Comparator
description: Standard systemic (IV) dexamethasone only
intervention type: Drug
intervention name: Methylprednisolone
description: Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
arm group label: Local Depomedrol plus IV dexamethasone
intervention type: Drug
intervention name: Dexamethasone
description: Administration of 10mg Dexamethasone IV intraoperatively
arm group label: IV dexamethasone
arm group label: Local Depomedrol plus IV dexamethasone
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kern Singh, MD
role: Principal Investigator
affiliation: Rush University Medical Center
citation: Schizas C, Tzinieris N, Tsiridis E, Kosmopoulos V. Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience. Int Orthop. 2009 Dec;33(6):1683-8. doi: 10.1007/s00264-008-0687-8. Epub 2008 Nov 21.
PMID: 19023571
citation: McGirt MJ, Parker SL, Lerner J, Engelhart L, Knight T, Wang MY. Comparative analysis of perioperative surgical site infection after minimally invasive versus open posterior/transforaminal lumbar interbody fusion: analysis of hospital billing and discharge data from 5170 patients. J Neurosurg Spine. 2011 Jun;14(6):771-8. doi: 10.3171/2011.1.SPINE10571. Epub 2011 Mar 18.
PMID: 21417699
citation: Ranguis SC, Li D, Webster AC. Perioperative epidural steroids for lumbar spine surgery in degenerative spinal disease. A review. J Neurosurg Spine. 2010 Dec;13(6):745-57. doi: 10.3171/2010.6.SPINE09796.
PMID: 21121754
citation: Jamjoom BA, Jamjoom AB. Efficacy of intraoperative epidural steroids in lumbar discectomy: a systematic review. BMC Musculoskelet Disord. 2014 May 5;15:146. doi: 10.1186/1471-2474-15-146.
PMID: 24885519
citation: Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6. doi: 10.1097/00024720-200208000-00002.
PMID: 12177541
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: Kern Singh
investigator title: Professor, Department of Orthopaedic Surgery
mesh term: Aphasia
mesh term: Dexamethasone
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: No