NCT04846543

Bioresorbable Intramedullary Nailing of Forearm Fractures

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Thomas Klestil · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Forearm Fracture

Interventions

Type	Name	Description
OTHER	MRI Scan	MRI scan

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2021-04-15
• Last updated: 2021-04-15

Locations

9 sites across 7 countries: Austria, Denmark, France, Germany, Hungary, Portugal, Switzerland