The Activa IM-Nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nail™.
Residual risk related to re-fracture rate will be addressed by this PMCF study. The research question is, if the re-fracture risk with Activa IM-nail is in line with the other treatment methods, namely ESIN. Primary objective: will be to assess clinical outcome by determining re-fracture rate of all treated patients, difference of re-fracture rate depending on the fracture type determined by X-ray (e.g. greenstick vs. non-greenstick fracture), subject's age, BMI, surgical technique, immobilization time and bony union formation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
220
MRI scan
Landesklinikum Moedling
Mödling, Lower Austria, Austria
RECRUITINGHerlev and Gentofte University Hospital Department of Orthopedic Surgery
Herlev, Denmark
NOT_YET_RECRUITINGRefracture rate
Assessment of refracture rate
Time frame: First year after operation
Absorption of implant
MRI scans are performed to evaluate soft tissue reaction and biodegradability
Time frame: One and two years after operation
Bony union
Bony union depending on fracture type and immobilization time, return to sport
Time frame: One year after operation
Monteggia lesion and equivalent
Safety and performance of operative technique in Monteggia´s lesion
Time frame: 2 years after operation
Cost effectiveness
HTA assessment for different health care systems in Europe
Time frame: 1 year after operation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hvidovre Hospital
Hvidovre, Denmark
NOT_YET_RECRUITINGLille University Center, Jeanne de Flandre Hospital
Lille, France
NOT_YET_RECRUITINGUniversity Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery
Lübeck, Schleswig-Holstein, Germany
NOT_YET_RECRUITINGPéterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery
Budapest, Hungary
RECRUITINGPécs University Hospital, Department of Pediatrics
Pécs, Hungary
NOT_YET_RECRUITINGHospital Pediátrico - CHUC, EPE
Coimbra, Portugal
NOT_YET_RECRUITINGCentre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
NOT_YET_RECRUITING