NCT06453083

Brief Summary

The investigators primary purpose of this study is to determine if the addition of a short course use of steroids following surgery for Adolescent Idiopathic Scoliosis (AIS) will improve post-operative pain management and shorten hospital length of stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for early_phase_1 pain

Timeline
Completed

Started Jan 2023

Typical duration for early_phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

June 5, 2024

Last Update Submit

January 5, 2025

Conditions

Pain

Keywords

Adolescent Idiopathic Scoliosis (AIS)SteroidMedrolPlaceboPain

Outcome Measures

Primary Outcomes (6)

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Day 2, post (AIS) surgery

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Day 3, post (AIS) surgery

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Day 4, post (AIS) surgery

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Day 5, post (AIS) surgery

  • Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Day 6, post (AIS) surgery

Study Arms (2)

Placebo tablets

PLACEBO COMPARATOR

Encapsulated placebo tablets per day (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg.)

Drug: Placebo

Medrol tablets

EXPERIMENTAL

Encapsulated steroid Medrol tablets (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg)

Drug: Medrol

Interventions

PlaceboDRUG

Placebo tablets will be dispensed to the participants for 6-days.

Placebo tablets
MedrolDRUG

Medrol tablets will be dispensed to the participants for 6-days.

Also known as: methylprednisolone
Medrol tablets

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age range of 10-21
  • received AIS surgery

You may not qualify if:

  • participants out of the age range 10-21
  • other forms of scoliosis (not AIS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Joshua Klatt, M.D.

    University of Utah Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 11, 2024

Study Start

January 13, 2023

Primary Completion

December 17, 2024

Study Completion

December 17, 2024

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)