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Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 5, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Start date: Nov 1, 2024 to Nov 1, 2025
    • Site contact updated
    • Publications: details revised at 1 of 9 entries
    v3
  2. Notable Primary completion date: Apr 1, 2024 to Apr 1, 2026
    • Start date: Nov 1, 2023 to Nov 1, 2024
    • Study completion date: Dec 31, 2025 to Dec 31, 2028
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06023043
Lead Sponsor Children's Hospital Los Angeles
Conditions
(from sponsor)
Neuromuscular Scoliosis, Adolescent Idiopathic Scoliosis
Related terms Scoliosis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov