Conservative Versus Intramedullary Nailing for Pediatric Tibial Shaft Fractures
ConditionFracture of Tibia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorTurku University Hospital
About this trial
Tibial shaft fracture is a common fracture in the pediatric and adolescent population. The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment.
The investigators will conduct a multicenter, randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Open fracture
Compartment syndrome
Neurovascular deficit
Pathological fracture
Trial design
Design model
Parallel
Treatments tested in this trial
intramedullary nailing
Procedure/SurgeryFlexible intramedullary nailing using 2 nails
casting
Procedure/Surgerycasting with long leg cast
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: CastingOther 1 intervention
Group B: intramedullary nailingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Malunion
malunion described as coronal angulation over 5 degrees, sagittal angulation over 10 degrees, over 50% cortical overlap and over 1 cm shortening.
Time frame
one yearSecondary outcomes
1
Pediatric Quality of Life Inventory
PedsQL
Time frame
one year2
number of reinterventions
any reoperations or remanipulations
Time frame
two year follow up period3
complication
reoperation, infection, compartment syndrome, nerve injury
Time frame
two year follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Turku University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Kuopio University Hospital
Collaborator
Oulu University Hospital
Collaborator
Tampere University Hospital
Collaborator
Source ClinicalTrials.gov
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