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Postoperative Steroids for Scoliosis

Phase 4
Waitlist Available
Led By Lindsay Andras, MD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat AIS or NMS
Be younger than 65 years old
Must not have
Prior instrumentation or spine surgery
Non AIS or NMS patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 years from date of surgery.
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effects of using steroids after surgery for scoliosis to help reduce opioid use, facilitate early mobilization, and affect wound complications and scar formation.

Who is the study for?
This trial is for young people aged 9-18 with Adolescent Idiopathic Scoliosis (AIS) or Neuromuscular Scoliosis (NMS), who are scheduled for posterior spinal fusion surgery. It's not open to those who've had prior spine surgeries, have conditions like spina bifida that affect wound healing, steroid allergies, or substance abuse issues.
What is being tested?
The study tests if using steroids right after scoliosis surgery can reduce pain medication needs and help patients move sooner. It also looks at whether steroids impact wound healing and scar appearance over time. Participants will be randomly assigned to receive steroids post-surgery or not.
What are the potential side effects?
Potential side effects of Dexamethasone may include increased risk of infection, blood sugar changes, stomach ulcers, mood swings, and delayed wound healing which could influence the surgical outcome.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 9 and 18 years old and will have surgery to correct my curved spine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had previous spine surgery or a procedure involving spinal instruments.
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I do not have AIS (Adenocarcinoma in Situ) or NMS (Non-Muscle Invasive Bladder Cancer).
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I am not between the ages of 9 and 18.
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I am not undergoing spinal fusion surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 years from date of surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 years from date of surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Length of Stay
Post Operative Opioid Use
Secondary study objectives
Body Mass Index
Patient-Reported Outcomes Measurement Information System (PROMIS)
Post Operative Ambulation (for ambulatory patients)
+4 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Cerebrospinal fluid leak
2%
Deep Vein Thrombosis
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: With Steroid (WS)Experimental Treatment1 Intervention
With Dexamethasone (WS)
Group II: No Steroid (NS)Active Control1 Intervention
No Dexamethasone (NS)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
249 Previous Clinical Trials
5,074,574 Total Patients Enrolled
2 Trials studying Scoliosis
20 Patients Enrolled for Scoliosis
Lindsay Andras, MDPrincipal InvestigatorChildren's Hospital Los Angeles
1 Previous Clinical Trials
92 Total Patients Enrolled
~67 spots leftby Apr 2026
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