ClinicalTrials.gg
Active, not recruitingNCT04207892Updated Sep 12, 2025

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

An observational study in Long Bone Fractures, sponsored by AO Innovation Translation Center. Active, not recruiting at 17 sites in 12 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by AO Innovation Translation Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
Up to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Long Bone Fractures
03

In context

Lead sponsor

AO Innovation Translation Center is the lead sponsor of 32 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive pediatric patients with key long bone fractures.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Interventions

  • ProcedureConservative (non-surgical) treatment

    Cast Sling Splint Collar

  • ProcedureSurgical treatment

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

06

What researchers measure

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

    Time frame: up to 24 months

Secondary outcomes

  1. 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)

    Time frame: up to 24 months

  2. Leg length discrepancy

    The Leg Length Discrepancy (LLD) will be measured using the standing blocks method

    Time frame: up to 24 months

  3. Return to full activity

    Time to full weight-bearing, time to full activity, and time to return to kindergarten/school

    Time frame: up to 24 months

  4. Implant removal

    Assessment if implant removal was done.

    Time frame: up to 24 months

  5. Patient-reported outcome

    Patient Reported Outcomes of Fracture Healing

    Time frame: up to 24 months

07

Study locations

17 sites
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2022 (actual). Primary completion is estimated for May 2027, 61 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2019
First posted
Dec 23, 2019
StartActual
Apr 5, 2022
Primary completionEst.
May 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Sep 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04207892
Lead sponsor
AO Innovation Translation Center
Responsible party
Sponsor
First posted
Dec 23, 2019
Start date
Apr 5, 2022
Primary completion
May 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 12, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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