Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

• ClinicalTrials.gov Identifier: NCT03327272
• Recruitment Status: Withdrawn
• First Posted: October 31, 2017
• Last Update Posted: November 20, 2020
• Sponsor: Rush University Medical Center
• 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:

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 (Clinical Trial)
• Actual Enrollment: 0 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
• Actual Primary Completion Date: July 24, 2020
• Actual Study Completion Date: July 24, 2020

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 :

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

• 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

Locations

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

• Principal Investigator: Kern Singh, MD; Rush University Medical Center

More Information

• Responsible Party: Kern Singh, Professor, Department of Orthopaedic Surgery, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT03327272
• Other Study ID Numbers: 17102301
• First Posted: October 31, 2017
• Last Update Posted: November 20, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

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