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Clinical Trial 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™.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04846543
Study type Interventional
Source Danube University Krems
Contact Christoph Roeder, MD
Phone +4322529004
Email christoph.roeder@moedling.lknoe.at
Status Recruiting
Phase N/A
Start date March 1, 2021
Completion date September 2024

See also
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Completed NCT03906929 - Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures N/A
Completed NCT03297047 - Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children N/A
Terminated NCT00763880 - Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction Phase 4
Recruiting NCT04941612 - Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures N/A
Completed NCT02769117 - Bone Ultrasound to Access Fracture Healing N/A
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Terminated NCT03097757 - Trial of Ultrasound Guidance for Reduction of Pediatric Forearm Fractures N/A
Completed NCT03474900 - Biodegradable Versus Titanium Nailing in Forearm Shaft Fractures in Children N/A
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