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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04207892
Registration number
NCT04207892
Ethics application status
Date submitted
19/12/2019
Date registered
23/12/2019
Date last updated
28/02/2024
Titles & IDs
Public title
Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
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Scientific title
PedORTHO-A Prospective Multicenter Observational Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
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Secondary ID [1]
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PedORTHO
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Long Bone Fractures
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Conservative (non-surgical) treatment
Treatment: Surgery - Surgical treatment
Treatment: Surgery: Conservative (non-surgical) treatment
Cast Sling Splint Collar
Treatment: Surgery: Surgical treatment
Elastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Data collection of fracture and trauma details
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Assessment method [1]
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To analyze the AO Pediatric Long Bone Fracture Classification in terms of utility for treatment decision-making and prediction of fracture outcomes
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Timepoint [1]
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up to 24 months
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Secondary outcome [1]
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Axial deviation and range of motion (ROM)
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Assessment method [1]
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Axial deviation or difference in ROM in the shoulder (abduction/adduction, internal rotation/external rotation, flexion/extension), elbow (flexion/extension, varus/valgus), wrist (flexion/extension, abduction/adduction, supination/pronation), hip (flexion/extension, abduction/adduction, internal rotation/external rotation (in flexion)), knee (flexion/extension), ankle (flexion/extension, supination/pronation, abduction/adduction)
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Timepoint [1]
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up to 24 months
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Secondary outcome [2]
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Leg length discrepancy
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Assessment method [2]
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The Leg Length Discrepancy (LLD) will be measured using the standing blocks method
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Timepoint [2]
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up to 24 months
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Secondary outcome [3]
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Return to full activity
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Assessment method [3]
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Time to full weight-bearing, time to full activity, and time to return to kindergarten/school
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Timepoint [3]
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up to 24 months
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Secondary outcome [4]
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Implant removal
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Assessment method [4]
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Assessment if implant removal was done.
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Timepoint [4]
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up to 24 months
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Secondary outcome [5]
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Patient-reported outcome
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Assessment method [5]
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Patient Reported Outcomes of Fracture Healing
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Timepoint [5]
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up to 24 months
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Queensland Children's Hospital - Brisbane
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Recruitment hospital [2]
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The Children's Hospital at Westmead - Sydney
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Recruitment postcode(s) [1]
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4101 - Brisbane
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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Country [2]
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United States of America
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State/province [2]
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Missouri
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Country [3]
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Canada
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State/province [3]
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Halifax
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Country [4]
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Canada
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State/province [4]
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Ottawa
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Country [5]
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Canada
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State/province [5]
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Toronto
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Country [6]
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Canada
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State/province [6]
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Vancouver
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Country [7]
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Chile
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State/province [7]
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Valdivia
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Country [8]
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China
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State/province [8]
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Shanghai
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Country [9]
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China
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State/province [9]
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Tianjin
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Country [10]
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Croatia
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State/province [10]
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Rijeka
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Country [11]
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Germany
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State/province [11]
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Karlsruhe
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Country [12]
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Ghana
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State/province [12]
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Tamale
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Country [13]
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Greece
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State/province [13]
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Patras
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Country [14]
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India
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State/province [14]
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Mangalore
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Country [15]
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Pakistan
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State/province [15]
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Peshawar
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Country [16]
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Spain
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State/province [16]
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Barcelona
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Country [17]
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Spain
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State/province [17]
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Valladolid
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Country [18]
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Venezuela
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State/province [18]
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Caracas
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Funding & Sponsors
Primary sponsor type
Other
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Name
AO Innovation Translation Center
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04207892
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Aleksandra Vidakovic
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Address
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Country
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Phone
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+41 44 200 24 20
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04207892
Download to PDF