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

Description

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

Conditions

Long Bone Fractures

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Study Overview

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Study Details

Study overview

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

PedORTHO-A Prospective Multicenter Observational Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children

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

Condition
Long Bone Fractures
Intervention / Treatment

-

Contacts and Locations

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Columbia

University of Missouri Health Care, Columbia, Missouri, United States, 65212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AO Innovation Translation Center,

Kishore Mulpuri, Prof, PRINCIPAL_INVESTIGATOR, BC Children's Hospital, Vancouver

Emily Schaeffer, Dr, PRINCIPAL_INVESTIGATOR, BC Children's Hospital, Vancouver

Alexander Joeris, Prof, PRINCIPAL_INVESTIGATOR, AO foundation

Study Record Dates

2028-12-31