Status:
RECRUITING
Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Children With Medical Complexity (CMC)
Multiple Chronic Conditions
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
The goal of this pilot hybrid type I efficacy/implementation trial is to assess a newly developed decision support tool patients, parents, and providers to use during surgical treatment decision makin...
Detailed Description
Neuromuscular scoliosis (NMS) can result in severe disability for children. Non-operative management including bracing and physical therapy minimally slows scoliosis progression, but operative managem...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Parent-child dyads of children with neuromuscular scoliosis who speak English and Spanish.
- Child is between ages 8-21 years of age and they are coming into the pediatric orthopaedic surgery clinic for consultation about potential surgery for NMS.
- NMS is defined as having neurologic impairment (NI) and scoliosis using relevant ICD-9 or ICD-10 codes from Feudtner, et al. 2014 or Berry, et al. 2012. or a qualifying diagnosis per the Pediatric Spine Study Group definition of NMS.
- All pediatric orthopaedic surgeons and neurosurgeons who treat neuromuscular scoliosis at our study sites will be eligible participants.
- Exclusion criteria:
- Families whose child with NMS is less than 8 years of age at time of orthopaedic consultation because surgery at a younger age usually indicates an atypical case.
- Children with the diagnosis of Duchenne's or Becker's muscular dystrophy due to potential disease modifying therapies that may alter curve progression.
Exclusion
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07167927
Start Date
October 21 2025
End Date
March 31 2027
Last Update
December 5 2025
Active Locations (2)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of Utah
Salt Lake City, Utah, United States, 84114