Postoperative Steroids for Scoliosis

Recruiting in Palo Alto (17 mi)

Overseen byLindsay M Andras, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Children's Hospital Los Angeles

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lindsay M Andras, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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.

Inclusion Criteria

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

Individuals must fulfill all the requirements in order to take part in this study.

Exclusion Criteria

I have a condition like spina bifida that affects how my wounds heal.

I have had previous spine surgery or a procedure involving spinal instruments.

Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

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Treatment Details

Interventions

Dexamethasone (Corticosteroid)

Trial OverviewThe 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.

Participant Groups

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)