Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06023043
PHASE4

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

Sponsor: Children's Hospital Los Angeles

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

9 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-11-01

Completion Date

2028-12-31

Last Updated

2025-03-05

Healthy Volunteers

No

Interventions

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)

Locations (1)

Children's Hospital Los Angeles

Los Angeles, California, United States