Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Mar 8;14(3):e079836.
doi: 10.1136/bmjopen-2023-079836.

Management of long bone fractures and traumatic hip dislocations in paediatric patients: study protocol for a prospective global multicentre observational cohort registry

Bryn O Zomar  1   2 , Maio Chen  3 , Emily K Schaeffer  4   2 , Kishore Mulpuri  1   2 , Alexander Joeris  3 ; PedORTHO Study Group
Collaborators, Affiliations

Management of long bone fractures and traumatic hip dislocations in paediatric patients: study protocol for a prospective global multicentre observational cohort registry

Bryn O Zomar et al. BMJ Open. .

Abstract

Introduction: Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making.

Methods and analysis: Eligible paediatric patients (N=750-1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24-36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.

Ethics and dissemination: Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.

Trial registration number: NCT04207892.

Keywords: Paediatric orthopaedics; Paediatric surgery; Patient Reported Outcome Measures; REGISTRIES; Trauma management.

PubMed Disclaimer

Conflict of interest statement

Competing interests: KM reports other financial activities (outside the submitted work) with I’m a HIPpy Foundation, Pega Medical, View and PrecisionOS; personal fees from IPSEN and OrthoPediatrics; non-financial support from DePuy Synthes, Johnson & Johnson, Allergan, IPSEN and Pega Medical; and grants from OrthoPediatrics, Pediatric Orthopaedic Society of North America and Canadian Institutes of Health Research.

Similar articles

See all similar articles

Cited by

References

    1. AO pediatric comprehensive classification of long bone fractures (PCCF). J Orthop Trauma 2018;32:S117–40. 10.1097/BOT.0000000000001065 - DOI - PubMed
    1. Cruz AI, Kleiner JE, Gil JA, et al. . Inpatient surgical treatment of Paediatric proximal Humerus fractures between 2000 and 2012. J Child Orthop 2018;12:111–6. 10.1302/1863-2548.12.170220 - DOI - PMC - PubMed
    1. Fernandez FF, Eberhardt O, Langendörfer M, et al. . Treatment of severely displaced proximal Humeral fractures in children with retrograde elastic stable Intramedullary nailing. Injury 2008;39:1453–9. 10.1016/j.injury.2008.04.001 - DOI - PubMed
    1. Hutchinson PH, Bae DS, Waters PM. Intramedullary nailing versus percutaneous pin fixation of pediatric proximal Humerus fractures: a comparison of complications and early radiographic results. J Pediatr Orthop 2011;31:617–22. 10.1097/BPO.0b013e3182210903 - DOI - PubMed
    1. Schwendenwein E, Hajdu S, Gaebler C, et al. . Displaced fractures of the proximal Humerus in children require open/closed reduction and internal fixation. Eur J Pediatr Surg 2004;14:51–5. 10.1055/s-2004-815781 - DOI - PubMed

Publication types

Associated data