Bioresorbable Intramedullary Nailing of Forearm Fractures

Forearm Fracture Clinical Trial

— BRINFF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04846543
• Other study ID #: DanubeUK3031
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2021
• Source: Danube University Krems
• Contact: Christoph Roeder, MD
• Phone: +4322529004
• Email: christoph.roeder[@]moedling.lknoe.at
• Is FDA regulated: No
• Study type: Interventional

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™.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: September 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Forearm Fracture
• Fractures, Bone

Intervention

Other:
• MRI Scan
MRI scan

Locations

Country	Name	City	State
Austria	Landesklinikum Moedling	Mödling	Lower Austria
Denmark	Herlev and Gentofte University Hospital Department of Orthopedic Surgery	Herlev
Denmark	Hvidovre Hospital	Hvidovre
France	Lille University Center, Jeanne de Flandre Hospital	Lille
Germany	University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery	Lübeck	Schleswig-Holstein
Hungary	Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery	Budapest
Hungary	Pécs University Hospital, Department of Pediatrics	Pécs
Portugal	Hospital Pediátrico - CHUC, EPE	Coimbra
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Klestil	Bioretec Ltd.

Countries where clinical trial is conducted

Austria,  Denmark,  France,  Germany,  Hungary,  Portugal,  Switzerland, 

References & Publications (1)

Korhonen L, Perhomaa M, Kyrö A, Pokka T, Serlo W, Merikanto J, Sinikumpu JJ. Intramedullary nailing of forearm shaft fractures by biodegradable compared with titanium nails: Results of a prospective randomized trial in children with at least two years of follow-up. Biomaterials. 2018 Dec;185:383-392. doi: 10.1016/j.biomaterials.2018.09.011. Epub 2018 Sep 11. — View Citation

Outcome

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