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

Last updated: February 13, 2025
Sponsor: AO Innovation Translation Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Conservative (non-surgical) treatment

Surgical treatment

Clinical Study ID

NCT04207892
PedORTHO
  • Ages < 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 toparticipate in the registry, including obtaining imaging and adhering to follow-upprocedures according to standard of care in each clinic

  • Willingness and ability of the parent(s) to support the patient in his/her studyparticipation

  • Ability of parents or a legal guardian to understand the content of the patientinformation/ICF and to sign and date the IRB/EC approved written informed consentform

Exclusion

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 shaftfracture, forearm fracture, or femoral neck fracture at greater than 4 weekspostinjury

  • Unable to provide the legal consent

  • Inability of the patient/parents/legally responsible caregiver to participate inimaging and/or FU procedures

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Conservative (non-surgical) treatment
Phase:
Study Start date:
April 05, 2022
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Queensland Children's Hospital

    Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • The Children's Hospital at Westmead

    Sydney,
    Australia

    Active - Recruiting

  • IWK Health Centre

    Halifax,
    Canada

    Terminated

  • Children's Hospital of Eastern Ontario (CHEO)

    Ottawa,
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto,
    Canada

    Active - Recruiting

  • BC Children's Hospital

    Vancouver,
    Canada

    Active - Recruiting

  • Hospital Base Valdivia

    Valdivia,
    Chile

    Active - Recruiting

  • Shanghai Children's Medical Center

    Shanghai,
    China

    Site Not Available

  • Tianjin Hospital

    Tianjin,
    China

    Site Not Available

  • Clinical Hospital Centre Rijeka

    Rijeka,
    Croatia

    Active - Recruiting

  • Kinderchirurgische Klinik, Klinikum Karlsruhe

    Karlsruhe,
    Germany

    Active - Recruiting

  • Tamale Teaching Hospital

    Tamale,
    Ghana

    Active - Recruiting

  • Karamandaneio Children's Hospital

    Patras,
    Greece

    Active - Recruiting

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

    Mangalore,
    India

    Active - Recruiting

  • Lady Reading Hospital

    Peshawar,
    Pakistan

    Active - Recruiting

  • Hospital Sant Joan de Déu Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario del Río Hortega

    Valladolid,
    Spain

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Missouri Health Care

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Hospital Universitario de Caracas

    Caracas,
    Venezuela

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.