Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT06023043
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Adolescent Idiopathic Scoliosis
  • Neuromuscular Scoliosis

Eligibility Criteria

Sex
ALL
Age
9 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    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)

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Mar 2025
Primary completion
Apr 1, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: No Steroid (NS)
    No Dexamethasone (NS)
  • Experimental: With Steroid (WS)
    With Dexamethasone (WS)

Primary Outcome Measure

Length of Stay [ Time Frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Tiffany Phan
[email protected]
3108488377
Lindsay Andras, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital Los Angeles· Los Angeles, CA

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