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

NCT04207892 | Active Not Recruiting

• 1 other identifier: PedORTHO
• Study Type: observational
• Target: 1,000
• Locations: 12 countries
• Sites: 17

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

Conditions

Long Bone Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Axial deviation and range of motion (ROM)

  up to 24 months

• Leg length discrepancy

  up to 24 months

• Return to full activity

  up to 24 months

• Implant removal

  up to 24 months

• Patient-reported outcome

  up to 24 months

Interventions

Conservative (non-surgical) treatment PROCEDURE

Cast Sling Splint Collar

Surgical treatment PROCEDURE

Elastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Consecutive pediatric patients with key long bone fractures.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (17)

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Queensland Children's Hospital

Brisbane, Queensland, 4101, Australia

Location

The Children's Hospital at Westmead

Sydney, Australia

Location

IWK Health Centre

Halifax, Canada

Location

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Canada

Location

The Hospital for Sick Children

Toronto, Canada

Location

BC Children's Hospital

Vancouver, Canada

Location

Hospital Base Valdivia

Valdivia, Chile

Location

Clinical Hospital Centre Rijeka

Rijeka, Croatia

Location

Kinderchirurgische Klinik, Klinikum Karlsruhe

Karlsruhe, Germany

Location

Tamale Teaching Hospital

Tamale, Ghana

Location

Karamandaneio Children's Hospital

Pátrai, Greece

Location

Tejasvini Hospital and Shantharam Shetty Institute of Orthopaedics and Traumatology (SSIOT) (Orthopaedics)

Mangalore, India

Location

Lady Reading Hospital

Peshawar, Pakistan

Location

Hospital Sant Joan de Déu Barcelona

Barcelona, Spain

Location

Hospital Universitario del Río Hortega

Valladolid, Spain

Location

Hospital Universitario de Caracas

Caracas, Venezuela

Location

Related Publications (1)

• Zomar BO, Chen M, Schaeffer EK, Mulpuri K, Joeris A; PedORTHO Study Group. Management of long bone fractures and traumatic hip dislocations in paediatric patients: study protocol for a prospective global multicentre observational cohort registry. BMJ Open. 2024 Mar 8;14(3):e079836. doi: 10.1136/bmjopen-2023-079836.

  PMID: 38458811 DERIVED

MeSH Terms

Interventions

Therapeutics; Surgical Procedures, Operative

Study Officials

• Kishore Mulpuri, Prof

  BC Children's Hospital, Vancouver

  PRINCIPAL INVESTIGATOR

• Emily Schaeffer, Dr

  BC Children's Hospital, Vancouver

  PRINCIPAL INVESTIGATOR

• Alexander Joeris, Prof

  AO foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: April 5, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); GH (1); CR (1); IN (1); PA (1); US (1); CL (1); DE (1); CA (4); ES (2); GR (1); VE (1)