Clinical trial NCT04846543: Bioresorbable Intramedullary Nailing of Forearm Fractures
Official title: PMCF Study - Verification of Activa IM-Nail™ Safety and Clinical Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Forearm Fracture
Lead sponsor: Danube University Krems
Sponsor class: OTHER
Collaborators: name: Bioretec Ltd.
First posted: 2021-04-15
Enrollment: 220
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Refracture rate
timeFrame: First year after operation
Secondary outcomes:
measure: Absorption of implant
timeFrame: One and two years after operation
measure: Bony union
timeFrame: One year after operation
measure: Monteggia lesion and equivalent
timeFrame: 2 years after operation
measure: Cost effectiveness
timeFrame: 1 year after operation
Other outcomes:
Locations:
city: Mödling
country: Austria
facility: Landesklinikum Moedling
state: Lower Austria
city: Herlev
country: Denmark
facility: Herlev and Gentofte University Hospital Department of Orthopedic Surgery
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Lille
country: France
facility: Lille University Center, Jeanne de Flandre Hospital
city: Lübeck
country: Germany
facility: University Medical Center Schleswig-Holstein, Campus Lübeck Department of Pediatric Surgery
state: Schleswig-Holstein
city: Budapest
country: Hungary
facility: Péterfy Hospital, National Trauma Center, Department of Pediatric Trauma Surgery
city: Pécs
country: Hungary
facility: Pécs University Hospital, Department of Pediatrics
city: Coimbra
country: Portugal
facility: Hospital Pediátrico - CHUC, EPE
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Landesklinikum Baden/Moedling
name: Christoph Roeder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korhonen L, Perhomaa M, Kyro 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.