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Clinical Trials in India / NCT04207892
Active, not recruiting Observational

Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children

NCT04207892 · tracked via the Priya Life Science India tracker
Sponsor
AO Innovation Translation Center
Phase
Observational
Started
2022-04-05
Last updated
2025-09-12

Condition(s) studied

Long Bone Fractures

Investigational drug(s) / intervention(s)

Conservative (non-surgical) treatmentSurgical treatment

Conservative (non-surgical) treatment: Cast Sling Splint Collar

Surgical treatment: Elastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation

Study 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

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)

Trial sites (17)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT04207892 on ClinicalTrials.gov ↗ ← All trials in India