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Search / Trial NCT06935331

Prospective Opioid-Free AIS Fusion

Launched by ORTHOCAROLINA RESEARCH INSTITUTE, INC. · Apr 16, 2025

Trial Information

Current as of August 23, 2025

Not yet recruiting

Keywords

Adolescent Idiopathic Scoliosis (Ais) Opioid Pain Management Pathway

ClinConnect Summary

This clinical trial, called "Prospective Opioid-Free AIS Fusion," is looking to compare two different ways of managing pain for young patients with adolescent idiopathic scoliosis (AIS) who need surgery. The study will focus on a new approach that does not use opioids, which are strong pain-relieving medications, and will compare it to the traditional method that includes opioids. The goal is to see how effective and safe the opioid-free method is for managing pain after surgery.

To be eligible for this trial, patients must be between 10 and 20 years old and diagnosed with idiopathic scoliosis, which means their scoliosis has no known cause. They will be undergoing a specific type of surgery called instrumented posterior spinal fusion (PSF), which helps correct the curvature of the spine. The trial is not yet recruiting participants, but it's important for potential candidates and their families to know that this study aims to find safer pain management options following surgery, which could benefit many young patients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Pediatric patients (10-20 years of age at the time of surgery)
  • Diagnosis of idiopathic scoliosis
  • Undergoing primary instrumented PSF
  • Exclusion Criteria:
  • Age \<10 years or \>20 years at time of surgery
  • Patients with non-idiopathic scoliosis etiology, ie neuromuscular or syndromic scoliosis
  • Patients undergoing non-fusion spinal surgeries, ie growing rods or tethering

About Orthocarolina Research Institute, Inc.

Orthocarolina Research Institute, Inc. is a leading clinical research organization dedicated to advancing orthopedic care through innovative research and clinical trials. With a focus on improving patient outcomes, the institute collaborates with a network of healthcare professionals to conduct rigorous studies that explore new treatments and technologies in orthopedics. Committed to ethical standards and scientific integrity, Orthocarolina Research Institute aims to enhance the understanding of musculoskeletal conditions, ultimately contributing to the development of evidence-based practices and improving the quality of life for patients.

Locations

Charlotte, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Michael Paloski, DO

Principal Investigator

OrthoCarolina Research Institute, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported