Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures
NCT ID: NCT04664517
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2021-05-01
2024-12-31
Brief Summary
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Detailed Description
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Primary outcome is 1) PROMIS Pediatric Item Bank v2.0 - Upper Extremity and 2) forearm pronation-supination range of motion at one-year follow-up. Secondary outcomes are Quick DASH, Pediatric pain questionnaire, Cosmetic VAS, wrist range of motion as well as any complications (malunion, delayed union, non-union or deep wound infection, peripheral nerve injury, need for re-intervention during 1-year follow-up) and costs of treatment.
The investigators hypothesize that flexible intramedullary nailing results in a superior outcome.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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FIN (Flexible intramedullary nail)
Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs.
Flexible intramedullary nail (FIN)
Both bone FIN
Long arm cast
Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks.
Reduction auder general anesthesia and long arm cast
Reduction and cast
Patient Choice FIN
Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs.
Flexible intramedullary nail (FIN)
Both bone FIN
Patient Choice cast
Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks.
Reduction auder general anesthesia and long arm cast
Reduction and cast
Interventions
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Flexible intramedullary nail (FIN)
Both bone FIN
Reduction auder general anesthesia and long arm cast
Reduction and cast
Eligibility Criteria
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Inclusion Criteria
* Open distal radial physis
* Both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2)
* More than 10 degrees of angulation
* with or without less than 10mm of shortening
Exclusion Criteria
* Gustilo-Anderson grade I-III open fracture
* Neurovascular deficit
* Compartment syndrome
* Pathologic fracture
* Patient not able to give a written informed consent
7 Years
12 Years
ALL
Yes
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Petra Grahn
Hand Surgeon, Principal investigator
Principal Investigators
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Ilkka Helenius, MD
Role: STUDY_DIRECTOR
Helsinki University Central Hospital
Petra Grahn, MD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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HUS New Childrens Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Petra Grahn, MD
Role: primary
Matti Ahonen, MD
Role: backup
Yrjänä Nietosvaara, MD
Role: primary
Juha-Jaakko Sinikumpu, MD
Role: primary
Anne Salonen, MD
Role: primary
Johanna Syvänen, MD
Role: primary
References
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Grahn P, Sinikumpu JJ, Nietosvaara Y, Syvanen J, Salonen A, Ahonen M, Helenius I. Casting versus flexible intramedullary nailing in displaced forearm shaft fractures in children aged 7-12 years: a study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 20;11(8):e048248. doi: 10.1136/bmjopen-2020-048248.
Related Links
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Protocol publication
Other Identifiers
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78/1801/2020
Identifier Type: -
Identifier Source: org_study_id
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