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

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Kern Singh, Rush University Medical Center

Study Description

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:

Reduced incidence and duration of postoperative pain and neurologic injury
Shorter hospital stay
Better short- and long-term outcomes

The study also aims to answer the following questions:

Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo?
Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo?
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

Genetics Home Reference related topics: Intervertebral disc disease

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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

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

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 Spondylosis Radiculopathy Spinal Cord Diseases 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

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