← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 years from date of surgery.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 9 and 18 years old and will have surgery to correct my curved spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 years from date of surgery.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of Stay

Post Operative Opioid Use

Secondary outcome measures

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

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

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

~2590

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,668 Total Patients Enrolled

2 Trials studying Scoliosis

20 Patients Enrolled for Scoliosis

Lindsay Andras, MDPrincipal InvestigatorChildren's Hospital Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has With Steroid (WS) been cleared by the U.S. Food and Drug Administration?

"Our team at Power has awarded WS a safety rating of 3, as it is currently classified as an approved therapeutic by Phase 4 standards."

Answered by AI

To what demographic is enrollment for this clinical investigation open?

"To partake in this research, participants must have been diagnosed with scoliosis and be between the ages of nine to eighteen. Approximately 100 candidates are needed for this trial."

Answered by AI

Are any new participants being admitted to this clinical trial?

"On the clinicaltrials.gov database, it is stated that this medical study has no current openings for participants - despite being initially posted on November 1st 2023 and last updated September 1st of the same year. However, there are 75 other trials actively seeking members at present."

Answered by AI

Are participants aged 40 or over eligible for consideration in this research project?

"This clinical trial is exclusively open to those aged between 9 and 18 years old. 71 studies are available for minors, while seniors over 65 can access nine different trials."

Answered by AI

What is the main aim of this investigation?

"The primary aim of this clinical study, which will span from the date a patient is admitted to hospital for surgery until two weeks post-operation, is to evaluate Post Operative Opioid Use. Secondary objectives include evaluating Return of Bowel Function (time till bowel sounds are noted and when first bowel movement occurs), Rate of wound complications requiring intervention (additional clinic visits, antibiotics or further interventions/hospitalization due to infection concerns) and Scar Appearance with Stony Brook's Scar Evaluation Scale ranging from 0-5 (worst - best)."

Answered by AI

Recent research and studies

Journal of Children's OrthopaedicsJournal

Clinical and Economic Implications of Early Discharge Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis

Fletcher, Nicholas D., Nader Shourbaji, Phillip M. Mitchell, Timothy S. Oswald, Dennis P. Devito, and Robert W. Bruce. 2014. “Clinical and Economic Implications of Early Discharge Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis”. Journal of Children's Orthopaedics. SAGE Publications. doi:10.1007/s11832-014-0587-y.

clinicaltrials.govStudy

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

Lindsay Andras 2023. "Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023043.

All > Scoliosis