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

Long Bone Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04207892
• Other study ID #: PedORTHO
• Status: Recruiting
• Start date: April 5, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: AO Innovation Translation Center
• Contact: Aleksandra Vidakovic
• Phone: +41 44 200 24 20
• Email: aleksandra.vidakovic[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Description:

This international registry will collect prospective treatment and outcomes data on specific, key non-pathological fractures in children with open physes. The long-term goal is to build this registry to include all fractures according to the AO pediatric fracture classification (AO PCCF). However, to establish proof-of-principle and study feasibility, the investigators aim to first begin with the inclusion of a limited number of key long bone fracture types for which optimal treatment and management are under particular debate, or for which substantial clinical equipoise exists. Consequently, the investigators aim to begin with separate registry arms based on defined fracture segments in specific bones. Each registry arm will be defined by a customized set of outcomes to be collected. Participants will be enrolled into these specific arms according to their injury diagnosis. The registry arms will be categorized as follows:

• Proximal humerus fractures

• Distal humerus fractures

• Proximal radius fractures

• Forearm shaft fractures

• Tibial shaft fractures (with/without fibula fracture)

All participants enrolled in the registry will be followed over the course of their treatment from the time of enrolment to end of treatment in accordance with the treating surgeon's regular clinical practice. All relevant information will be recorded at baseline and at each follow-up visit that participants attend at the orthopedic clinic, according to standard of care for each fracture type. A standardized set of prospective data including demographic information, baseline injury information, diagnosis, treatment details and clinical, radiographic, functional, and PROs will be collected for each participant. Data involving additional outcomes or variables may also be collected depending on the specific sub-study or registry arm that the participant is enrolled in.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Long Bone Fractures

Intervention

Procedure:
• Conservative (non-surgical) treatment
Cast Sling Splint Collar
• Surgical treatment
Elastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation

Locations

Country	Name	City	State
Australia	Queensland Children's Hospital	Brisbane	Queensland
Australia	The Children's Hospital at Westmead	Sydney
Canada	IWK Health Centre	Halifax
Canada	Children's Hospital of Eastern Ontario (CHEO)	Ottawa
Canada	The Hospital for Sick Children	Toronto
Canada	BC Children's Hospital	Vancouver
Chile	Hospital Base Valdivia	Valdivia
China	Shanghai Children's Medical Center	Shanghai
China	Tianjin Hospital	Tianjin
Croatia	Clinical Hospital Centre Rijeka	Rijeka
Germany	Kinderchirurgische Klinik, Klinikum Karlsruhe	Karlsruhe
Ghana	Tamale Teaching Hospital	Tamale
Greece	Karamandaneio Children's Hospital	Patras
India	Tejasvini Hospital and Shantharam Shetty Institute of Orthopaedics and Traumatology (SSIOT) (Orthopaedics)	Mangalore
Pakistan	Lady Reading Hospital	Peshawar
Spain	Hospital Sant Joan de Déu Barcelona	Barcelona
Spain	Hospital Universitario del Río Hortega	Valladolid
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of Missouri Health Care	Columbia	Missouri
Venezuela	Hospital Universitario de Caracas	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

United States,  Venezuela,  Australia,  Canada,  Chile,  China,  Croatia,  Germany,  Ghana,  Greece,  India,  Pakistan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data collection of fracture and trauma details	To analyze the AO Pediatric Long Bone Fracture Classification in terms of utility for treatment decision-making and prediction of fracture outcomes	up to 24 months
Secondary	Axial deviation and range of motion (ROM)	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)	up to 24 months
Secondary	Leg length discrepancy	The Leg Length Discrepancy (LLD) will be measured using the standing blocks method	up to 24 months
Secondary	Return to full activity	Time to full weight-bearing, time to full activity, and time to return to kindergarten/school	up to 24 months
Secondary	Implant removal	Assessment if implant removal was done.	up to 24 months
Secondary	Patient-reported outcome	Patient Reported Outcomes of Fracture Healing	up to 24 months