Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
- Conditions
- Long Bone Fractures
- Registration Number
- NCT04207892
- Lead Sponsor
- AO Innovation Translation Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Axial deviation and range of motion (ROM) up to 24 months Axial deviation or difference in ROM in the shoulder (abduction/adduction, internal rotation/external rotation, flexion/extension), elbow (flexion/extension, varus/valgus), wrist (flexion/extension, abduction/adduction, supination/pronation), hip (flexion/extension, abduction/adduction, internal rotation/external rotation (in flexion)), knee (flexion/extension), ankle (flexion/extension, supination/pronation, abduction/adduction)
Patient-reported outcome up to 24 months Patient Reported Outcomes of Fracture Healing
Leg length discrepancy up to 24 months The Leg Length Discrepancy (LLD) will be measured using the standing blocks method
Return to full activity up to 24 months Time to full weight-bearing, time to full activity, and time to return to kindergarten/school
Implant removal up to 24 months Assessment if implant removal was done.
Trial Locations
- Locations (17)
University of Missouri Health Care
๐บ๐ธColumbia, Missouri, United States
Queensland Children's Hospital
๐ฆ๐บBrisbane, Queensland, Australia
The Children's Hospital at Westmead
๐ฆ๐บSydney, Australia
IWK Health Centre
๐จ๐ฆHalifax, Canada
The Hospital for Sick Children
๐จ๐ฆToronto, Canada
Hospital Base Valdivia
๐จ๐ฑValdivia, Chile
Children's Hospital of Eastern Ontario (CHEO)
๐จ๐ฆOttawa, Canada
Kinderchirurgische Klinik, Klinikum Karlsruhe
๐ฉ๐ชKarlsruhe, Germany
Tamale Teaching Hospital
๐ฌ๐ญTamale, Ghana
Karamandaneio Children's Hospital
๐ฌ๐ทPatras, Greece
Tejasvini Hospital and Shantharam Shetty Institute of Orthopaedics and Traumatology (SSIOT) (Orthopaedics)
๐ฎ๐ณMangalore, India
Lady Reading Hospital
๐ต๐ฐPeshawar, Pakistan
Hospital Sant Joan de Dรฉu Barcelona
๐ช๐ธBarcelona, Spain
Hospital Universitario del Rรญo Hortega
๐ช๐ธValladolid, Spain
Hospital Universitario de Caracas
๐ป๐ชCaracas, Venezuela
BC Children's Hospital
๐จ๐ฆVancouver, Canada
Clinical Hospital Centre Rijeka
๐ญ๐ทRijeka, Croatia