Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

NCT06023043 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: CHLA-23-00124
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Scoliosis; Adolescent Idiopathic Scoliosis

Keywords

Steroid; Dexamethasone; Scoliosis

Outcome Measures

Primary Outcomes (2)

• Length of Stay

  Day/hours to discharge from hospital following completion of surgery.

  From date of hospitalization for surgery until date of first discharge, assessed up to two weeks

• Post Operative Opioid Use

  Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)

  From date of hospitalization for surgery until date of first discharge, assessed up to two weeks

Secondary Outcomes (7)

• Post Operative Ambulation (for ambulatory patients)

  From date of hospitalization for surgery until date of first discharge, assessed up to two weeks

• Return of Bowel Function

  From date of hospitalization for surgery until date of first discharge, assessed up to two weeks

• Rate of wound complications requiring intervention

  Less than 90 days from hospitalization

• Scar Appearance

  Immediately from enrollment through study completion, at an average of 2 years

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  Immediately from enrollment through study completion, at an average of 2 years

Study Arms (2)

No Steroid (NS)

NO INTERVENTION

No Dexamethasone (NS)

With Steroid (WS)

EXPERIMENTAL

With Dexamethasone (WS)

Drug: Dexamethasone

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)

With Steroid (WS)

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat AIS or NMS

You may not qualify if:

• Patients will be excluded if any of the following criteria are met at baseline:
• Prior instrumentation or spine surgery
• Conditions associated with increased wound healing issues such as spina bifida
• Non AIS or NMS patients
• Not undergoing PSF
• Outside the ages of 9-18
• Allergies to the steroids and/or their ingredients
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (9)

• Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014 May;8(3):257-63. doi: 10.1007/s11832-014-0587-y. Epub 2014 Apr 27.

  PMID: 24770995 BACKGROUND

• Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.

  PMID: 27927519 BACKGROUND

• Keohane D, Sheridan G, Harty J. Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty. J Orthop. 2020 Oct 7;22:449-453. doi: 10.1016/j.jor.2020.10.004. eCollection 2020 Nov-Dec.

  PMID: 33093753 BACKGROUND

• Fletcher ND, Ruska T, Austin TM, Guisse NF, Murphy JS, Bruce RW Jr. Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2020 Oct 21;102(20):1807-1813. doi: 10.2106/JBJS.20.00259.

  PMID: 33086348 BACKGROUND

• Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.

  PMID: 24809068 BACKGROUND

• Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084.

  PMID: 25554755 BACKGROUND

• Gonzalez L. Pediatric Opioid Prescribing: A Call for Calm. Pediatrics. 2021 Sep;148(3):e2021052190. doi: 10.1542/peds.2021-052190. Epub 2021 Aug 16. No abstract available.

  PMID: 34400573 BACKGROUND

• Singla A, Qureshi R, Chen DQ, Nourbakhsh A, Hassanzadeh H, Shimer AL, Shen FH. Risk of Surgical Site Infection and Mortality Following Lumbar Fusion Surgery in Patients With Chronic Steroid Usage and Chronic Methicillin-Resistant Staphylococcus aureus Infection. Spine (Phila Pa 1976). 2019 Apr 1;44(7):E408-E413. doi: 10.1097/BRS.0000000000002864.

  PMID: 30889145 BACKGROUND

• Chan P, Skaggs DL, Sanders AE, Villamor GA, Choi PD, Tolo VT, Andras LM. Pain is the Greatest Preoperative Concern for Patients and Parents Before Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1245-E1250. doi: 10.1097/BRS.0000000000002147.

  PMID: 28263228 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Lindsay Andras, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay M Andras, MD

CONTACT

323-361-2142; landras@chla.usc.edu

Tiffany Phan, BA

CONTACT

tphan@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Division Chief and Director of the Spine Program

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 5, 2023
• Study Start: November 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)