Clinical trial NCT04207892: Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
Official title: PedORTHO-A Prospective Multicenter Observational Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Long Bone Fractures
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive pediatric patients with key long bone fractures.

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.

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

Primary outcomes:
measure: Data collection of fracture and trauma details
timeFrame: up to 24 months
Secondary outcomes:
measure: Axial deviation and range of motion (ROM)
timeFrame: up to 24 months
measure: Leg length discrepancy
timeFrame: up to 24 months
measure: Return to full activity
timeFrame: up to 24 months
measure: Implant removal
timeFrame: up to 24 months
measure: Patient-reported outcome
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Queensland
city: Sydney
country: Australia
facility: The Children's Hospital at Westmead
city: Halifax
country: Canada
facility: IWK Health Centre
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario (CHEO)
city: Toronto
country: Canada
facility: The Hospital for Sick Children
city: Vancouver
country: Canada
facility: BC Children's Hospital
city: Valdivia
country: Chile
facility: Hospital Base Valdivia
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka
city: Karlsruhe
country: Germany
facility: Kinderchirurgische Klinik, Klinikum Karlsruhe
city: Tamale
country: Ghana
facility: Tamale Teaching Hospital
city: Patras
country: Greece
facility: Karamandaneio Children's Hospital
city: Mangalore
country: India
facility: Tejasvini Hospital and Shantharam Shetty Institute of Orthopaedics and Traumatology (SSIOT) (Orthopaedics)
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu Barcelona
city: Valladolid
country: Spain
facility: Hospital Universitario del Río Hortega
city: Caracas
country: Venezuela
facility: Hospital Universitario de Caracas
Study officials:
affiliation: BC Children's Hospital, Vancouver
name: Kishore Mulpuri, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: BC Children's Hospital, Vancouver
name: Emily Schaeffer, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: AO foundation
name: Alexander Joeris, Prof
role: PRINCIPAL_INVESTIGATOR
References: