ACTIVE_NOT_RECRUITING

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

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Conditions

Long Bone Fractures

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-04-05
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04207892

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.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Radiologically confirmed open physis in the injured bone at time of injury
  2. * Diagnosis of an isolated fracture according to the AO PCCF
  3. * 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
  4. * Willingness and ability of the parent(s) to support the patient in his/her study participation
  5. * 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
  1. * Radiologically confirmed closed physis in the injured bone at time of injury
  2. * Polytrauma/multiple fractures
  3. * Previous fracture of the same anatomical region
  4. * Underlying musculoskeletal or neuromuscular disorder
  5. * Present to participating centers with a displaced humeral fracture, tibial shaft fracture, forearm fracture, or femoral neck fracture at greater than 4 weeks postinjury
  6. * Unable to provide the legal consent
  7. * Inability of the patient/parents/legally responsible caregiver to participate in imaging and/or FU procedures

Contacts and Locations

Principal Investigator

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 Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-05
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2022-04-05
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Long Bone Fractures