Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

NCT03327272 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 17102301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenosis; Herniated Nucleus Pulposus; Degenerative Disc Disease; Spondylosis; Myelopathy; Radiculopathy; Myeloradiculopathy

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  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.

  2 year postoperative

Secondary Outcomes (6)

• Physical Functioning

  2 year postoperative

• Disability

  2 year postoperative

• General health status

  2 year postoperative

• Narcotic Consumption

  2 year postoperative

• Length of Stay

  1 week postoperative

Study Arms (2)

Local injection of methylprednisolone

ACTIVE COMPARATOR

Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure

Drug: Methylprednisolone

Local injection of saline

PLACEBO COMPARATOR

Administration of saline at surgical site prior to incision closure.

Drug: Saline

Interventions

Methylprednisolone DRUG

Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure

Also known as: Depomedrol

Local injection of methylprednisolone

Saline DRUG

Administration of saline at surgical site prior to incision closure

Local injection of saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Constriction, Pathologic; Intervertebral Disc Degeneration; Spondylosis; Spinal Cord Diseases; Radiculopathy

Interventions

Methylprednisolone; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kern Singh, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 31, 2017
• Study Start: May 22, 2018
• Primary Completion: July 24, 2020
• Study Completion: July 24, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)