Bioresorbable Intramedullary Nailing of Forearm Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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PMCF Study - Verification of Activa IM-Nail™ Safety and Clinical Performance

Conditions
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Forearm Fracture

Intervention / Treatment
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* Other: MRI Scan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI scan 1st and 2nd year<br>Additionally to routinely follow up, there will be an MRI scan of enrolled patients after one and two years in some of the study sites | Other: MRI Scan<br>* MRI scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refracture rate | Assessment of refracture rate | First year after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absorption of implant | MRI scans are performed to evaluate soft tissue reaction and biodegradability | One and two years after operation | 
| Bony union | Bony union depending on fracture type and immobilization time, return to sport | One year after operation | 
| Monteggia lesion and equivalent | Safety and performance of operative technique in Monteggia´s lesion | 2 years after operation | 
| Cost effectiveness | HTA assessment for different health care systems in Europe | 1 year after operation |