Bioresorbable Intramedullary Nailing of Forearm Fractures (BRINFF)

Thomas Klestil

Status

Enrolling

Conditions

Forearm Fracture

Treatments

Other: MRI Scan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04846543

DanubeUK3031

Details and patient eligibility

About

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™.

Full 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.

Enrollment

220 estimated patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

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.