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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
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative (non-surgical) treatment | Procedure | Cast Sling Splint Collar | ||
| Surgical treatment | Procedure | Elastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive pediatric patients with key long bone fractures.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States | ||
| Queensland Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38458811 | Derived | 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. |
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| up to 24 months |
| Leg length discrepancy | The Leg Length Discrepancy (LLD) will be measured using the standing blocks method | up to 24 months |
| Return to full activity | Time to full weight-bearing, time to full activity, and time to return to kindergarten/school | up to 24 months |
| Implant removal | Assessment if implant removal was done. | up to 24 months |
| Patient-reported outcome | Patient Reported Outcomes of Fracture Healing | up to 24 months |
| Brisbane |
| Queensland |
| 4101 |
| Australia |
| The Children's Hospital at Westmead | Sydney | Australia |
| 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 | Canada |
| Hospital Base Valdivia | Valdivia | Chile |
| Clinical Hospital Centre Rijeka | Rijeka | Croatia |
| Kinderchirurgische Klinik, Klinikum Karlsruhe | Karlsruhe | Germany |
| Tamale Teaching Hospital | Tamale | Ghana |
| Karamandaneio Children's Hospital | Pátrai | Greece |
| Tejasvini Hospital and Shantharam Shetty Institute of Orthopaedics and Traumatology (SSIOT) (Orthopaedics) | Mangalore | India |
| Lady Reading Hospital | Peshawar | Pakistan |
| Hospital Sant Joan de Déu Barcelona | Barcelona | Spain |
| Hospital Universitario del Río Hortega | Valladolid | Spain |
| Hospital Universitario de Caracas | Caracas | Venezuela |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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