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

NCT ID: NCT04207892

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Conservative (non-surgical) treatment

Cast Sling Splint Collar

Intervention Type: PROCEDURE

Surgical treatment

Elastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Innovation Translation Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kishore Mulpuri, Prof

Role: PRINCIPAL_INVESTIGATOR

BC Children's Hospital, Vancouver

Emily Schaeffer, Dr

Role: PRINCIPAL_INVESTIGATOR

BC Children's Hospital, Vancouver

Alexander Joeris, Prof

Role: PRINCIPAL_INVESTIGATOR

AO foundation

Locations

University of Missouri Health Care

Columbia, Missouri, United States

Queensland Children's Hospital

Brisbane, Queensland, Australia

The Children's Hospital at Westmead

Sydney, , Australia

IWK Health Centre

Halifax, , Canada

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, , Canada

The Hospital for Sick Children

Toronto, , Canada

BC Children's Hospital

Vancouver, , Canada

Hospital Base Valdivia

Valdivia, , Chile

Clinical Hospital Centre Rijeka

Rijeka, , Croatia

Kinderchirurgische Klinik, Klinikum Karlsruhe

Karlsruhe, , Germany

Tamale Teaching Hospital

Tamale, , Ghana

Karamandaneio Children's Hospital

Pátrai, , Greece

Tejasvini Hospital and Shantharam Shetty Institute of Orthopaedics and Traumatology (SSIOT) (Orthopaedics)

Mangalore, , India

Lady Reading Hospital

Peshawar, , Pakistan

Hospital Sant Joan de Déu Barcelona

Barcelona, , Spain

Hospital Universitario del Río Hortega

Valladolid, , Spain

Hospital Universitario de Caracas

Caracas, , Venezuela

Countries

United States; Australia; Canada; Chile; Croatia; Germany; Ghana; Greece; India; Pakistan; Spain; Venezuela

References

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.

Reference Type: DERIVED

PMID: 38458811 (View on PubMed)

Other Identifiers

PedORTHO

Identifier Type: -

Identifier Source: org_study_id