Status:
UNKNOWN
Bioresorbable Intramedullary Nailing of Forearm Fractures
Lead Sponsor:
Thomas Klestil
Collaborating Sponsors:
Bioretec Ltd.
Conditions:
Forearm Fracture
Eligibility:
All Genders
3-12 years
Phase:
NA
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 follo...
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, namel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04846543
Start Date
March 1 2021
End Date
September 1 2024
Last Update
April 15 2021
Active Locations (9)
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1
Landesklinikum Moedling
Mödling, Lower Austria, Austria, 2340
2
Herlev and Gentofte University Hospital Department of Orthopedic Surgery
Herlev, Denmark, 2730
3
Hvidovre Hospital
Hvidovre, Denmark, 2650
4
Lille University Center, Jeanne de Flandre Hospital
Lille, France, 59000