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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Stenosis Herniated Nucleus Pulposus Degenerative Disc Disease Spondylosis Myelopathy Radiculopathy Myeloradiculopathy Drug: Methylprednisolone Drug: Saline Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Local injection of methylprednisolone
Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure
 Drug: Methylprednisolone
Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
Other Name: Depomedrol
Placebo Comparator: Local injection of saline
Administration of saline at surgical site prior to incision closure.
 Drug: Saline
Administration of saline at surgical site prior to incision closure


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327272


Contacts
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Contact: Susan Dvojack, MS 3129426689 Susan_Dvojack@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Susan Dvojack    312-942-6689    Susan_Dvojack@rush.edu   
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Kern Singh, MD Rush University Medical Center
More Information
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Responsible Party: Kern Singh, Professor, Department of Orthopaedic Surgery, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03327272     History of Changes
Other Study ID Numbers: 17102301
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Radiculopathy
Spinal Cord Diseases
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Central Nervous System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
 Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal