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Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

NCT ID: NCT03327272

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-22

Study Completion Date

2020-07-24

Brief Summary

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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.

Detailed Description

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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?

Conditions

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Stenosis Herniated Nucleus Pulposus Degenerative Disc Disease Spondylosis Myelopathy Radiculopathy Myeloradiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Local injection of methylprednisolone

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

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

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

Local injection of saline

Administration of saline at surgical site prior to incision closure.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Administration of saline at surgical site prior to incision closure

Interventions

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Methylprednisolone

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

Intervention Type DRUG

Saline

Administration of saline at surgical site prior to incision closure

Intervention Type DRUG

Other Intervention Names

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Depomedrol

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kern Singh

Professor, Department of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kern Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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17102301

Identifier Type: -

Identifier Source: org_study_id