Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children (NCT04207892) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
United States, Australia, Canada1,000 participantsStarted 2022-04-05
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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