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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04207892




Registration number
NCT04207892
Ethics application status
Date submitted
19/12/2019
Date registered
23/12/2019

Titles & IDs
Public title
Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
Scientific title
PedORTHO-A Prospective Multicenter Observational Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
Secondary ID [1] 0 0
PedORTHO
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long Bone Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Data collection of fracture and trauma details
Timepoint [1] 0 0
up to 24 months
Secondary outcome [1] 0 0
Axial deviation and range of motion (ROM)
Timepoint [1] 0 0
up to 24 months
Secondary outcome [2] 0 0
Leg length discrepancy
Timepoint [2] 0 0
up to 24 months
Secondary outcome [3] 0 0
Return to full activity
Timepoint [3] 0 0
up to 24 months
Secondary outcome [4] 0 0
Implant removal
Timepoint [4] 0 0
up to 24 months
Secondary outcome [5] 0 0
Patient-reported outcome
Timepoint [5] 0 0
up to 24 months

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
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland Children's Hospital - Brisbane
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
Canada
State/province [3] 0 0
Halifax
Country [4] 0 0
Canada
State/province [4] 0 0
Ottawa
Country [5] 0 0
Canada
State/province [5] 0 0
Toronto
Country [6] 0 0
Canada
State/province [6] 0 0
Vancouver
Country [7] 0 0
Chile
State/province [7] 0 0
Valdivia
Country [8] 0 0
China
State/province [8] 0 0
Shanghai
Country [9] 0 0
China
State/province [9] 0 0
Tianjin
Country [10] 0 0
Croatia
State/province [10] 0 0
Rijeka
Country [11] 0 0
Germany
State/province [11] 0 0
Karlsruhe
Country [12] 0 0
Ghana
State/province [12] 0 0
Tamale
Country [13] 0 0
Greece
State/province [13] 0 0
Patras
Country [14] 0 0
India
State/province [14] 0 0
Mangalore
Country [15] 0 0
Pakistan
State/province [15] 0 0
Peshawar
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Valladolid
Country [18] 0 0
Venezuela
State/province [18] 0 0
Caracas

Funding & Sponsors
Primary sponsor type
Other
Name
AO Innovation Translation Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kishore Mulpuri, Prof
Address 0 0
BC Children's Hospital, Vancouver
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cynthia Sob, PhD
Address 0 0
Country 0 0
Phone 0 0
+41 79 893 74 28
Fax 0 0
Email 0 0
cynthia.sob@aofoundation.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04207892