Registry for tracking pediatric long bone fractures and health outcomes
PedORTHO-A Prospective Multicenter Observational Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
This study is tracking how children with certain long bone fractures heal over time to see which treatments work best for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | AO Innovation Translation Center Academic / other |
| Locations | 17 sites (Columbia, Missouri and 16 other locations) |
| Trial ID | NCT04207892 on ClinicalTrials.gov |
What this trial studies
This international registry collects prospective treatment and outcomes data on specific non-pathological long bone fractures in children with open physes. The study aims to establish proof-of-principle by initially focusing on key fracture types where optimal treatment is debated. Participants will be enrolled based on their injury diagnosis and followed throughout their treatment according to standard clinical practices. Data will be gathered at multiple follow-up visits to assess recovery and outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are children with radiologically confirmed open physis and isolated long bone fractures.
Not a fit: Patients with closed physis, multiple fractures, or underlying musculoskeletal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment strategies and health outcomes for children with long bone fractures.
How similar studies have performed: Other studies have shown success in using registries to improve treatment outcomes in pediatric orthopedic conditions, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbia, Missouri and 16 other locations
- University of Missouri Health Care — Columbia, Missouri, United States (Recruiting)
- Queensland Children's Hospital — Brisbane, Queensland, Australia (Recruiting)
- The Children's Hospital at Westmead — Sydney, Australia (Recruiting)
- IWK Health Centre — Halifax, Canada (Terminated)
- Children's Hospital of Eastern Ontario (CHEO) — Ottawa, Canada (Recruiting)
- The Hospital for Sick Children — Toronto, Canada (Recruiting)
- BC Children's Hospital — Vancouver, Canada (Recruiting)
- Hospital Base Valdivia — Valdivia, Chile (Recruiting)
- Clinical Hospital Centre Rijeka — Rijeka, Croatia (Recruiting)
- Kinderchirurgische Klinik, Klinikum Karlsruhe — Karlsruhe, Germany (Recruiting)
- Tamale Teaching Hospital — Tamale, Ghana (Terminated)
- Karamandaneio Children's Hospital — Patras, Greece (Recruiting)
- Tejasvini Hospital and Shantharam Shetty Institute of Orthopaedics and Traumatology (SSIOT) (Orthopaedics) — Mangalore, India (Recruiting)
- Lady Reading Hospital — Peshawar, Pakistan (Recruiting)
- Hospital Sant Joan de Déu Barcelona — Barcelona, Spain (Recruiting)
- Hospital Universitario del Río Hortega — Valladolid, Spain (Recruiting)
- Hospital Universitario de Caracas — Caracas, Venezuela (Recruiting)
Study contacts
- Principal investigator: Kishore Mulpuri, Prof — BC Children's Hospital, Vancouver
- Study coordinator: Cynthia Sob, PhD
- Email: cynthia.sob@aofoundation.org
- Phone: +41 79 893 74 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.