Forearm Fracture
Conditions
Brief summary
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™.
Detailed description
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.
Interventions
OTHERMRI Scan
MRI scan
Sponsors
Bioretec Ltd.
Thomas Klestil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Diaphyseal forearm fractures (radius or ulna or both) * Patients from 3 years to under 13 years, but the age limits depend on the biological development of the child and in addition
Exclusion criteria
* multifragmentary fractures, metaphyseal and epiphyseal fractures * Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection, or where a patient's cooperation cannot be guaranteed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refracture rate | First year after operation | Assessment of refracture rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absorption of implant | One and two years after operation | MRI scans are performed to evaluate soft tissue reaction and biodegradability |
| Bony union | One year after operation | Bony union depending on fracture type and immobilization time, return to sport |
| Monteggia lesion and equivalent | 2 years after operation | Safety and performance of operative technique in Monteggia´s lesion |
| Cost effectiveness | 1 year after operation | HTA assessment for different health care systems in Europe |
Countries
Austria, Denmark, France, Germany, Hungary, Portugal, Switzerland
Contacts
Primary ContactChristoph Roeder, MD
Backup ContactThomas Klestil, MD
Outcome results
None listed