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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Long Bone Fractures
• Intervention / Treatment: Procedure: Conservative (non-surgical) treatment; Procedure: Surgical treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • The Children's Hospital at Westmead
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Queensland CHILDREN'S HOSPITAL
• Canada
  • Halifax, Canada
    • IWK Health Centre
  • Ottawa, Canada
    • Children's Hospital of Eastern Ontario (CHEO)
  • Toronto, Canada
    • The Hospital for Sick Children
  • Vancouver, Canada
    • BC Children's Hospital
• Chile
  • Valdivia, Chile
    • Hospital Base Valdivia
• Croatia
  • Rijeka, Croatia
    • Clinical Hospital Centre Rijeka
• Germany
  • Karlsruhe, Germany
    • Kinderchirurgische Klinik, Klinikum Karlsruhe
• Ghana
  • Tamale, Ghana
    • Tamale Teaching Hospital
• Greece
  • Pátrai, Greece
    • Karamandaneio Children's Hospital
• India
  • Mangalore, India
    • Tejasvini Hospital and Shantharam Shetty Institute of Orthopaedics and Traumatology (SSIOT) (Orthopaedics)
• Pakistan
  • Peshawar, Pakistan
    • Lady Reading Hospital
• Spain
  • Barcelona, Spain
    • Hospital Sant Joan de Deu Barcelona
  • Valladolid, Spain
    • Hospital Universitario del Río Hortega
• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care
• Venezuela
  • Caracas, Venezuela
    • Hospital Universitario de Caracas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive pediatric patients with key long bone fractures.

Description

Inclusion Criteria:

• Radiologically confirmed open physis in the injured bone at time of injury
• Diagnosis of an isolated fracture according to the AO PCCF
• Willingness and ability of the patient/parents/legally responsible care giver to participate in the registry, including obtaining imaging and adhering to follow-up procedures according to standard of care in each clinic
• Willingness and ability of the parent(s) to support the patient in his/her study participation
• Ability of parents or a legal guardian to understand the content of the patient information/ICF and to sign and date the IRB/EC approved written informed consent form

Exclusion Criteria:

• Radiologically confirmed closed physis in the injured bone at time of injury
• Polytrauma/multiple fractures
• Previous fracture of the same anatomical region
• Underlying musculoskeletal or neuromuscular disorder
• Present to participating centers with a displaced humeral fracture, tibial shaft fracture, forearm fracture, or femoral neck fracture at greater than 4 weeks postinjury
• Unable to provide the legal consent
• Inability of the patient/parents/legally responsible caregiver to participate in imaging and/or FU procedures

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data collection of fracture and trauma details	To analyze the AO Pediatric Long Bone Fracture Classification in terms of utility for treatment decision-making and prediction of fracture outcomes	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial deviation and range of motion (ROM)	Axial deviation or difference in ROM in the shoulder (abduction/adduction, internal rotation/external rotation, flexion/extension), elbow (flexion/extension, varus/valgus), wrist (flexion/extension, abduction/adduction, supination/pronation), hip (flexion/extension, abduction/adduction, internal rotation/external rotation (in flexion)), knee (flexion/extension), ankle (flexion/extension, supination/pronation, abduction/adduction)	up to 24 months
Leg length discrepancy	The Leg Length Discrepancy (LLD) will be measured using the standing blocks method	up to 24 months
Return to full activity	Time to full weight-bearing, time to full activity, and time to return to kindergarten/school	up to 24 months
Implant removal	Assessment if implant removal was done.	up to 24 months
Patient-reported outcome	Patient Reported Outcomes of Fracture Healing	up to 24 months

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Kishore Mulpuri, Prof, BC Children's Hospital, Vancouver; Principal Investigator: Emily Schaeffer, Dr, BC Children's Hospital, Vancouver; Principal Investigator: Alexander Joeris, Prof, AO foundation

Publications and helpful links

General Publications

• Zomar BO, Chen M, Schaeffer EK, Mulpuri K, Joeris A; PedORTHO Study Group. Management of long bone fractures and traumatic hip dislocations in paediatric patients: study protocol for a prospective global multicentre observational cohort registry. BMJ Open. 2024 Mar 8;14(3):e079836. doi: 10.1136/bmjopen-2023-079836.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Therapeutics; Surgical Procedures, Operative
• Other Study ID Numbers: PedORTHO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No