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
Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Data collection of fracture and trauma details — up to 24 months To analyze the AO Pediatric Long Bone Fracture Classification in terms of utility for treatment decision-making and prediction of fracture outcomes
Trial sites (17)
Facility
City
Region
Status
University of Missouri Health Care
Columbia
Missouri
Queensland Children's Hospital
Brisbane
Queensland
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
More AO Innovation Translation Center trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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