Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

March 3, 2025 updated by: Lindsay Andras, Children's Hospital Los Angeles

A Randomized Trial of Postoperative Steroid Use Following Posterior Spinal Fusion in 100-subject Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis (NMS)

The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion.

The main question it aims to answer are:

  • What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)?
  • Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation?

Participants will:

  • Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years

  • Have clinical photos of their incision at 3 months, 1 year, and 2 years

    • Their photos will be assessed using the stony book scar evaluation scale
  • For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand.
  • Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Children remain a vulnerable population historically known to be undertreated and underrecognized for their pain, only perpetuating the complexity of managing pain control in this cohort. Children's Hospital of Los Angeles conducted a study observing patient and family's perioperative perception regarding their posterior spinal fusion and found that pain control is a primary concern, however, surgeons did not share the sentiment. Opioids were primarily the medication of choice with dentists and surgeons accounting for approximately two-thirds of opioid prescriptions. However, with the rise of the national opioid crisis and its adverse effects not limited to addiction, providers are gravitating towards alternative multidisciplinary use of medication to manage pain.

Though steroids were formerly used for surgical patients, concerns regarding increased surgical site infection and wound healing complications were of major concern. However, to the investigators knowledge, these issues have only been documented with chronic steroid use. The impact of immediate use of steroids postoperatively for accelerated discharge has gained momentum in the literature with its demonstration in facilitating earlier mobility, decreased pain scores, and decreased narcotic usage. A retrospective study suggested that post-operative dexamethasone administration can have the positive effect of reducing opioid use in pediatric PSF patients without increasing wound complications.

The proposed study aims to rigorously observe the effects of post operative steroid use in its facilitation in early mobilization in adolescent PSF patients, while also understanding the incidence of wound complications and long-term scar formation. Should the randomized controlled trial align with the literature, the implementation of post-operative steroids could potentially alter standard of care for adolescent PSF patients.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
        • Contact:
        • Contact:
          • Lindsay Andras, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all of the inclusion criteria to participate in this study:

• Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat AIS or NMS

Exclusion Criteria:

Patients will be excluded if any of the following criteria are met at baseline:

  • Prior instrumentation or spine surgery
  • Conditions associated with increased wound healing issues such as spina bifida
  • Non AIS or NMS patients
  • Not undergoing PSF
  • Outside the ages of 9-18
  • Allergies to the steroids and/or their ingredients
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Steroid (NS)
No Dexamethasone (NS)
Experimental: With Steroid (WS)
With Dexamethasone (WS)
Drug: Dexamethasone
Three (3) post operative intravenous dexamethasone injections at 8-hour intervals post-operatively. Dosing will be determined as 0.15 mg/kg per dose (WS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Day/hours to discharge from hospital following completion of surgery.
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Post Operative Opioid Use
Time Frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Ambulation (for ambulatory patients)
Time Frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Will obtain number of feet ambulated with physical therapy (PT) staff on each post operative day. Will record number of days postoperatively until PT clearance for discharge.
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Return of Bowel Function
Time Frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement.
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Rate of wound complications requiring intervention
Time Frame: Less than 90 days from hospitalization
3.1) Additional clinic visits for drainage or wound concerns will be recorded. 3.2) Use of antibiotic for superficial wound issues will be recorded. 3.3) Any additional operative intervention or hospitalization for concern/management of an infection.
Less than 90 days from hospitalization
Scar Appearance
Time Frame: Immediately from enrollment through study completion, at an average of 2 years

Clinical photos will be obtained and graded with Stony Brook Scar Evaluation Scale.

The Stony Brook Scar evaluation scale ranges from a minimum value of 0 (worst) to a maximum value of 5 (best).
Immediately from enrollment through study completion, at an average of 2 years
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame: Immediately from enrollment through study completion, at an average of 2 years

The Patient-Reported Outcomes Measurement Information System is a validated quality of life and outcome questionnaire used for various studies. This will also be completed by the parent, if the patient is unable to do so.

PROMIS domains that will be utilized include:

  1. pain interference

    • A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used.
    • A higher score is indicative of more problems with pain hindering activities than a lower score.

  2. physical activity

    • A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used.
    • A higher score is indicative of engagement with more physical activities than a lower score.

  3. mobility

    • A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used.
    • A higher score is indicative of engagement with more mobility than a lower score.
Immediately from enrollment through study completion, at an average of 2 years
Post-Operative Complications
Time Frame: Within 2 years from date of surgery.
Any additional emergency room visits/readmission or revision surgery
Within 2 years from date of surgery.
Body Mass Index
Time Frame: Immediately from enrollment through study completion, at an average of 2 years
Weight, measured in kilograms, and height, measured in meters, will be combined to report body mass index in kg/m^2
Immediately from enrollment through study completion, at an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Los Angeles

Investigators

  • Principal Investigator: Lindsay Andras, MD, Children's Hospital Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHLA-23-00124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescent Idiopathic Scoliosis

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe