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

Running, not enrolling

Conditions studied: Long Bone Fractures

In brief

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

Key facts

Study ID

NCT04207892

Run by

AO Innovation Translation Center

People needed

1000

Starts

2022-04-05

Expected to finish

2028-12-31

Last updated by the study team

2025-09-12

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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