NCT04207892

Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children

PedORTHO-A Prospective Multicenter Observational Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

International registry to collect prospective treatment and outcomes data on specific, key non-pathological fractures in children with open physes. Data will be collected during follow-up visits according to standard of care at 3 to 8 weeks, 3, 6, 12 and 24 months

Detailed description

This international registry will collect prospective treatment and outcomes data on specific, key non-pathological fractures in children with open physes. The long-term goal is to build this registry to include all fractures according to the AO pediatric fracture classification (AO PCCF). However, to establish proof-of-principle and study feasibility, the investigators aim to first begin with the inclusion of a limited number of key long bone fracture types for which optimal treatment and management are under particular debate, or for which substantial clinical equipoise exists. Consequently, the investigators aim to begin with separate registry arms based on defined fracture segments in specific bones. Each registry arm will be defined by a customized set of outcomes to be collected. Participants will be enrolled into these specific arms according to their injury diagnosis. The registry arms will be categorized as follows: * Proximal humerus fractures * Distal humerus fractures * Proximal radius fractures * Forearm shaft fractures * Tibial shaft fractures (with/without fibula fracture) All participants enrolled in the registry will be followed over the course of their treatment from the time of enrolment to end of treatment in accordance with the treating surgeon's regular clinical practice. All relevant information will be recorded at baseline and at each follow-up visit that participants attend at the orthopedic clinic, according to standard of care for each fracture type. A standardized set of prospective data including demographic information, baseline injury information, diagnosis, treatment details and clinical, radiographic, functional, and PROs will be collected for each participant. Data involving additional outcomes or variables may also be collected depending on the specific sub-study or registry arm that the participant is enrolled in.

Conditions

• Long Bone Fractures

Interventions

Type	Name	Description
PROCEDURE	Conservative (non-surgical) treatment	Cast Sling Splint Collar
PROCEDURE	Surgical treatment	Elastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation

Timeline

• Start date: 2022-04-05
• Primary completion: 2027-05-31
• Completion: 2028-12-31
• First posted: 2019-12-23
• Last updated: 2025-09-12

Locations

17 sites across 12 countries: United States, Australia, Canada, Chile, Croatia, Germany, Ghana, Greece, India, Pakistan, Spain, Venezuela