Long Bone FracturesNCT04207892
Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
An observational study of Long Bone Fractures, run by AO Innovation Translation Center at 17 sites in 12 countries.
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 Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Long Bone Fractures
- What is being tested?
- Conservative (non-surgical) treatment and Surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 17 sitesin 12 countries
- Study dates
- 5 Apr 2022to 31 Dec 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Consecutive pediatric patients with key long bone fractures.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 12 countries.
17 sites in 12 countries
Canada4 sites
IWK Health Centre
Halifax
Children's Hospital of Eastern Ontario (CHEO)
Ottawa
The Hospital for Sick Children
Toronto
BC Children's Hospital
Vancouver
Australia2 sites
Queensland Children's Hospital
Brisbane, Queensland, 4101
The Children's Hospital at Westmead
Sydney
Spain2 sites
Hospital Sant Joan de Déu Barcelona
Barcelona
Hospital Universitario del Río Hortega
Valladolid
United States1 site
University of Missouri Health Care
Columbia, Missouri, 65212
India1 site
Tejasvini Hospital and Shantharam Shetty Institute of Orthopaedics and Traumatology (SSIOT) (Orthopaedics)
Mangalore
About this study
Official title: PedORTHO-A Prospective Multicenter Observational Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
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
Read the detailed 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.
- Conditions
- Long Bone Fractures
- Being tested
- Conservative (non-surgical) treatment, Surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative (non-surgical) treatmentProcedure or surgery
Cast Sling Splint Collar
Surgical treatmentProcedure or surgery
Elastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 months
Secondary outcomes (5)
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)
Measured: up to 24 months
Leg length discrepancy
The Leg Length Discrepancy (LLD) will be measured using the standing blocks method
Measured: up to 24 months
Return to full activity
Time to full weight-bearing, time to full activity, and time to return to kindergarten/school
Measured: up to 24 months
Implant removal
Assessment if implant removal was done.
Measured: up to 24 months
Patient-reported outcome
Patient Reported Outcomes of Fracture Healing
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start5 Apr 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long Bone FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kishore Mulpuri, Prof, Principal investigator, BC Children's Hospital, VancouverEmily Schaeffer, Dr, Principal investigator, BC Children's Hospital, VancouverAlexander Joeris, Prof, Principal investigator, AO foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207892
- Sponsor's protocol ID
- PedORTHO
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38458811
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PedORTHO-A Prospective Multicenter Observational Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children
- ClinicalTrials.gov ID
- NCT04207892
- Acronym / sponsor ID
- PedORTHO
- Conditions
- Long Bone Fractures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Consecutive pediatric patients with key long bone fractures.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative (non-surgical) treatmentCast Sling Splint Collar | Procedure or surgery | – |
| Surgical treatmentElastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation | Procedure or surgery | – |
Primary outcome
Data collection of fracture and trauma details
Time frame: up to 24 months
To analyze the AO Pediatric Long Bone Fracture Classification in terms of utility for treatment decision-making and prediction of fracture outcomes
5 secondary outcomes
Axial deviation and range of motion (ROM)
Time frame: up to 24 months
Leg length discrepancy
Time frame: up to 24 months
Return to full activity
Time frame: up to 24 months
Implant removal
Time frame: up to 24 months
Patient-reported outcome
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 38458811Zomar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
17 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long Bone Fractures, run by AO Innovation Translation Center at 17 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada, Australia, Spain, United States, Chile and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection of fracture and trauma details (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.